[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Unknown Section]
[Pages 1158-1169]
[FR Doc No: 2013-29632]

Vol. 79

Tuesday,

No. 4

January 7, 2014

Part VIII

Department of Health and Human Services

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Semiannual Regulatory Agenda

Federal Register / Vol. 79, No. 4 / Tuesday, January 7, 2014 /
Unified Agenda

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

25 CFR Ch. V

42 CFR Chs. I-V

45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII

Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual regulatory agenda.

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SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order
12866 require the Department semiannually to issue an inventory of
rulemaking actions under development to provide the public a summary of
forthcoming regulatory actions. This information will help the public
more effectively participate in the Department's regulatory activity,
and the Department welcomes comments on any aspect of this agenda.

FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive
Secretary, Department of Health and Human Services, Washington, DC
20201.

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
(HHS) is the Federal Government's principal agency for protecting the
health of all Americans and providing essential human services,
especially for those who are least able to help themselves. HHS
enhances the health and well-being of Americans by promoting effective
health and human services and by fostering sound, sustained advances in
the sciences underlying medicine, public health, and social services.
This agenda presents the rulemaking activities that the Department
expects to undertake in the foreseeable future to advance this mission.
The agenda furthers several Departmental goals, including strengthening
health care; advancing scientific knowledge and innovation; advancing
the health, safety, and well-being of the American people; increasing
efficiency, transparency, and accountability of HHS programs; and
strengthening the Nation's health and human services infrastructure and
workforce.
    HHS has an agency-wide effort to support the agenda's purpose of
encouraging more effective public participation in the regulatory
process. The Department's Public Participation Task Force, which was
created as part of the HHS Retrospective Review plan in response to
Executive Order 13563 (Improving Regulation and Regulatory Review),
regularly meets to identify ways to make the rulemaking process more
accessible to the general public. For example, to encourage public
participation, HHS regularly updates its main regulatory Web page
(http://www.HHS.gov/regulations/), which includes links to HHS rules
currently open for public comment and provides a ``regulations
toolkit'' with background information on regulations, the commenting
process, how public comments influence the development of a rule, and
how the public can provide effective comments. HHS also actively
encourages meaningful public participation in its retrospective review
of regulations, including through a comment form on the HHS
retrospective review Web page (http://www.HHS.gov/RetrospectiveReview).
In addition, a cross-agency team at HHS is currently considering how to
increase efficiency in rulemaking by organizing public comment on
proposed rules.
    The rulemaking abstracts included in this paper issue of the
Federal Register only cover, as required by the Regulatory Flexibility
Act of 1980, those prospective HHS rulemakings likely to have a
significant economic impact on a substantial number of small entities.
The Department's complete Regulatory Agenda is accessible online at
http://www.RegInfo.gov.

    Dated: August 21, 2013.
Jennifer M. Cannistra,
Executive Secretary to the Department.

               Food and Drug Administration--Prerule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
274.......................  Over-the-Counter (OTC)             0910-AF43
                             Drug Review--Sunscreen
                             Products.
275.......................  Prescription Drug                  0910-AG14
                             Marketing Act of 1987;
                             Prescription Drug
                             Amendments of 1992;
                             Policies, Requirements,
                             and Administrative
                             Procedures (Section 610
                             Review).
------------------------------------------------------------------------

            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
276.......................  Food Labeling; Revision of         0910-AF22
                             the Nutrition and
                             Supplement Facts Labels
                             (Reg Plan Seq No. 49).
277.......................  Food Labeling: Serving             0910-AF23
                             Sizes of Foods That Can
                             Reasonably Be Consumed at
                             One-Eating Occasion; Dual-
                             Column Labeling;
                             Updating, Modifying, and
                             Establishing Certain
                             RACCs (Reg Plan Seq No.
                             50).
278.......................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review--Cough/Cold
                             (Antihistamine) Products.
279.......................  Over-the-Counter (OTC)             0910-AF36
                             Drug Review--Internal
                             Analgesic Products.
280.......................  Updated Standards for              0910-AG09
                             Labeling of Pet Food.
281.......................  Current Good Manufacturing         0910-AG10
                             Practice, Hazard
                             Analysis, and Risk-Based
                             Preventive Controls for
                             Food for Animals (Reg
                             Plan Seq No. 51).
282.......................  Over-the-Counter (OTC)             0910-AG12
                             Drug Review--Pediatric
                             Dosing for Cough/Cold
                             Products.
283.......................  Electronic Distribution of         0910-AG18
                             Prescribing Information
                             for Human Prescription
                             Drugs Including
                             Biological Products.
284.......................  Produce Safety Regulation.         0910-AG35
285.......................  Hazard Analysis and Risk-          0910-AG36
                             Based Preventive Controls.
286.......................  ``Tobacco Products''               0910-AG38
                             Subject to the Federal
                             Food, Drug, and Cosmetic
                             Act, as Amended by the
                             Family Smoking Prevention
                             and Tobacco Control Act
                             (Reg Plan Seq No. 52).
287.......................  Requirements for the               0910-AG59
                             Testing and Reporting of
                             Tobacco Product
                             Constituents,
                             Ingredients, and
                             Additives.
288.......................  Foreign Supplier                   0910-AG64
                             Verification Program.
289.......................  Supplemental Applications          0910-AG94
                             Proposing Labeling
                             Changes for Approved
                             Drugs and Biological
                             Products (Reg Plan Seq
                             No. 55).

290.......................  Veterinary Feed Directive          0910-AG95
                             (Reg Plan Seq No. 56).
291.......................  Format and Content of              0910-AG96
                             Reports Intended to
                             Demonstrate Substantial
                             Equivalence.
292.......................  Radiology Devices;                 0910-AH03
                             Designation of Special
                             Controls for the Computed
                             Tomography X-Ray System.
293.......................  Mammography Quality                0910-AH04
                             Standards Act; Regulatory
                             Amendments.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.

             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
294.......................  Content and Format of              0910-AF11
                             Labeling for Human
                             Prescription Drugs and
                             Biologics; Requirements
                             for Pregnancy and
                             Lactation Labeling.
295.......................  Infant Formula: Current            0910-AF27
                             Good Manufacturing
                             Practices; Quality
                             Control Procedures;
                             Notification
                             Requirements; Records and
                             Reports; and Quality
                             Factors.
296.......................  Combinations of                    0910-AF33
                             Bronchodilators With
                             Nasal Decongestants or
                             Expectorants; Cold,
                             Cough, Allergy,
                             Bronchodilator, and
                             Antiasthmatic Drug
                             Products for Over-the-
                             Counter Human Use.
297.......................  Laser Products; Proposed           0910-AF87
                             Amendment to Performance
                             Standard.
298.......................  Food Labeling: Calorie             0910-AG56
                             Labeling of Articles of
                             Food Sold in Vending
                             Machines (Reg Plan Seq
                             No. 57).
299.......................  Food Labeling: Nutrition           0910-AG57
                             Labeling of Standard Menu
                             Items in Restaurants and
                             Similar Retail Food
                             Establishments (Reg Plan
                             Seq No. 58).
300.......................  Use of Certain Symbols in          0910-AG74
                             Labeling.
301.......................  Requirements for the               0910-AG81
                             Submission of Data Needed
                             To Calculate User Fees
                             for Manufacturers and
                             Importers of Tobacco
                             Products.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.

             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
302.......................  Over-the-Counter (OTC)             0910-AF69
                             Drug Review--Topical
                             Antimicrobial Drug
                             Products.
303.......................  Amendment to the Current           0910-AG20
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Second Phase.
304.......................  Human Subject Protection;          0910-AG48
                             Acceptance of Data From
                             Clinical Studies for
                             Medical Devices.
305.......................  Amendments to the Current          0910-AG70
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Components.
------------------------------------------------------------------------

             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
306.......................  Unique Device                      0910-AG31
                             Identification.
307.......................  Food Labeling: Serving             0910-AG82
                             Sizes; Reference Amount
                             and Serving Size
                             Declaration for Hard
                             Candies and Breath Mints.
308.......................  Food Labeling; Gluten-Free         0910-AG84
                             Labeling of Foods.
------------------------------------------------------------------------

      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
309.......................  Emergency Preparedness             0938-AO91
                             Requirements for Medicare
                             and Medicaid
                             Participating Providers
                             and Suppliers (CMS-3178-
                             P) (Section 610 Review).
310.......................  Prospective Payment System         0938-AR62
                             for Federally Qualified
                             Health Centers; Changes
                             to Contracting Policies
                             for Rural Health Clinics
                             and CLIA Enforcement
                             Actions for Proficiency
                             Testing Referral (CMS-
                             1443-F) (Section 610
                             Review).
311.......................  Hospital Inpatient                 0938-AS11
                             Prospective Payment
                             System for Acute Care
                             Hospitals and the Long-
                             Term Care Hospital
                             Prospective Payment
                             System and Fiscal Year
                             2015 Rates (CMS-1607-P)
                             (Reg Plan Seq No. 62).
312.......................  CY 2015 Revisions to               0938-AS12
                             Payment Policies under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1612-P) (Reg
                             Plan Seq No. 63).
313.......................  CY 2015 Hospital                   0938-AS15
                             Outpatient Prospective
                             Payment System (PPS)
                             Policy Changes and
                             Payment Rates, and CY
                             2015 Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1613-
                             P) (Reg Plan Seq No. 64).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.

       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
314.......................  Covered Outpatient Drugs           0938-AQ41
                             (CMS-2345-F) (Section 610
                             Review).
315.......................  CY 2014 Changes to the End-        0938-AR55
                             Stage Renal Disease
                             (ESRD) Prospective
                             Payment System, ESRD
                             Quality Incentive
                             Program, and Durable
                             Medical Equipment (CMS-
                             1526-F).
316.......................  Revisions to Payment               0938-AR56
                             Policies Under the
                             Physician Fee Schedule
                             and Medicare Part B for
                             CY 2014 (CMS-1600-F).
317.......................  Adoption of Operating              0938-AS01
                             Rules for HIPAA
                             Transactions (CMS-0036-
                             IFC).
------------------------------------------------------------------------

       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
318.......................  Changes to the Hospital            0938-AR53
                             Inpatient and Long-Term
                             Care Prospective Payment
                             System for FY 2014 (CMS-
                             1599-F).
319.......................  Changes to the Hospital            0938-AR54
                             Outpatient Prospective
                             Payment System and
                             Ambulatory Surgical
                             Center Payment System for
                             CY 2014 (CMS-1601-F).
------------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Prerule Stage

274. Over-the-Counter (OTC) Drug Review--Sunscreen Products

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first of
the future actions will address the safety of sunscreen active
ingredients.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM (Sunscreen and Insect            02/22/07  72 FR 7941
 Repellent).
ANPRM Comment Period End............   05/23/07
NPRM (UVA/UVB)......................   08/27/07  72 FR 49070
NPRM Comment Period End.............   12/26/07
Final Action (UVA/UVB)..............   06/17/11  76 FR 35620
NPRM (Effectiveness)................   06/17/11  76 FR 35672
NPRM (Effectiveness) Comment Period    09/15/11
 End.
ANPRM (Dosage Forms)................   06/17/11  76 FR 35669
ANPRM (Dosage Forms) Comment Period    09/15/11
 End.
ANPRM (Safety)......................   06/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Eng, Regulatory Project Manager, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone:<PHONE_NUMBER>, Fax: 301 796-
9899, Email<EMAIL_ADDRESS>    RIN: 0910-AF43

275. Prescription Drug Marketing Act of 1987; Prescription Drug
Amendments of 1992; Policies, Requirements, and Administrative
Procedures (Section 610 Review)

    Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 351 to
353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381
    Abstract: FDA is currently reviewing regulations promulgated under
the Prescription Drug Marketing Act (PDMA). FDA is undertaking this
review to determine whether the regulations should be changed or
rescinded to minimize adverse impacts on a substantial number of small
entities. FDA has extended again the completion date by 1 year and will
complete the review by November 2013.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Begin Review of Current Regulation..   11/24/08
End Review of Current Regulation....   11/00/13
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Howard Muller, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New
Hampshire Avenue, Silver Spring, MD 20993-0002, Phone:<PHONE_NUMBER>,
Fax:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0910-AG14

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

276. Food Labeling; Revision of the Nutrition and Supplement Facts
Labels

    Regulatory Plan: This entry is Seq. No. 49 in part II of this issue
of the Federal Register.
    RIN: 0910-AF22

277. Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed at One-Eating Occasion; Dual-Column Labeling; Updating,
Modifying, and Establishing Certain RACCs

    Regulatory Plan: This entry is Seq. No. 50 in part II of this issue
of the Federal Register.
    RIN: 0910-AF23

278. Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine)
Products

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371

    Abstract: FDA will be proposing a rule to add the common cold
indication to certain over-the-counter (OTC) antihistamine active
ingredients. This proposed rule is the result of collaboration under
the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts
to reduce unnecessary duplication and differences. This pilot exercise
will help determine the feasibility of developing an ongoing mechanism
for alignment in review and adoption of OTC drug monograph elements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Reopening of Administrative Record..   08/25/00  65 FR 51780
Comment Period End..................   11/24/00
NPRM (Amendment) (Common Cold)......   12/00/13
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Regulatory Health Project
Manager, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 22, Room
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-3713, Fax:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0910-AF31

279. Over-the-Counter (OTC) Drug Review--Internal Analgesic Products

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21
U.S.C. 379e
    Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses acetaminophen safety. The second action addresses
products marketed for children under 2 years old and weight- and age-
based dosing for children's products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Amendment) (Required Warnings    12/26/06  71 FR 77314
 and Other Labeling).
NPRM Comment Period End.............   05/25/07
Final Action (Required Warnings and    04/29/09  74 FR 19385
 Other Labeling).
Final Action (Correction)...........   06/30/09  74 FR 31177
Final Action (Technical Amendment)..   11/25/09  74 FR 61512
NPRM (Amendment) (Pediatric)........   07/00/14
NPRM (Amendment) (Acetaminophen)....   12/00/14
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Regulatory Health Project
Manager, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 22, Room
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-3713, Fax:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0910-AF36

280. Updated Standards for Labeling of Pet Food

    Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec
1002(a)(3)
    Abstract: FDA is proposing updated standards for the labeling of
pet food that include nutritional and ingredient information, as well
as style and formatting standards. FDA is taking this action to provide
pet owners and animal health professionals more complete and useful
information about the nutrient content and ingredient composition of
pet food products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/14
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: William Burkholder, Veterinary Medical Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519
Standish Place, Rockville, MD 20855, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    RIN: 0910-AG09

281. Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Food for Animals

    Regulatory Plan: This entry is Seq. No. 51 in part II of this issue
of the Federal Register.
    RIN: 0910-AG10

282. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/
Cold Products

    Legal Authority: 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C.
355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
will propose changes to the final monograph to address safety and
efficacy issues associated with pediatric cough and cold products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/14
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Regulatory Health Project
Manager, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 22, Room
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-3713, Fax:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0910-AG12

283. Electronic Distribution of Prescribing Information for Human
Prescription Drugs Including Biological Products

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21
U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360;
21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374;
21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C.
264
    Abstract: This rule would require electronic package inserts for
human drug and biological prescription products with limited
exceptions, in lieu of paper, which is currently used. These inserts
contain prescribing information intended for healthcare practitioners.
This would ensure that

the information accompanying the product is the most up-to-date
information regarding important safety and efficacy issues about these
products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/00/14
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Megan Velez, Policy Analyst, Department of Health
and Human Services, Food and Drug Administration, Office of Policy, WO
32, Room 4249, 10903 New Hampshire Avenue, Silver Spring, MD 20993,
Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0910-AG18

284. Produce Safety Regulation

    Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42
U.S.C. 264; Pub. L. 111-353 (signed on Jan. 4, 2011)
    Abstract: FDA is proposing to establish science-based minimum
standards for the safe production and harvesting of those types of
fruits and vegetables that are raw agricultural commodities for which
the Secretary has determined that such standards minimize the risk of
serious adverse health consequences or death. The purpose of the
proposed rule is to reduce the risk of illness associated with fresh
produce.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/16/13  78 FR 3503
NPRM Comment Period End.............   05/16/13
NPRM Comment Period Extended........   04/26/13  78 FR 24692
NPRM Comment Period Extended End....   09/16/13
NPRM Comment Period Extended........   08/09/13  78 FR 48637
NPRM Comment Period Extended End....   11/15/13
Notice of Intent To Prepare an         08/19/13  78 FR 50358
 Environmental Impact Statement for
 the Proposed Rule.
Notice of Intent To Prepare            11/15/13
 Environmental Impact Statement for
 the Proposed Rule Comment Period
 End.
NPRM Comment Period Extended........   11/20/13  78 FR 69605
NPRM Comment Period Extended End....   11/22/13
Environmental Impact Statement for     11/18/13  78 FR 69006
 the Proposed Rule; Comment Period
 Extended.
Environmental Impact Statement for     03/14/14
 the Proposed Rule; Comment Period
 Extended End.
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Samir Assar, Supervisory Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition, Office of Food Safety,
5100 Paint Branch Parkway, College Park, MD 20740, Phone:<PHONE_NUMBER>,
Email<EMAIL_ADDRESS>    RIN: 0910-AG35

285. Hazard Analysis and Risk-Based Preventive Controls

    Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub.
L. 111-353 (signed on Jan. 4, 2011)
    Abstract: This proposed rule would require a food facility to have
and implement preventive controls to significantly minimize or prevent
the occurrence of hazards that could affect food manufactured,
processed, packed, or held by the facility. This action is intended to
prevent or, at a minimum, quickly identify foodborne pathogens before
they get into the food supply.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/16/13  78 FR 3646
NPRM Comment Period End.............   05/16/13
NPRM Comment Period Extended........   04/26/13  78 FR 24691
NPRM Comment Period Extended End....   09/16/13
NPRM Comment Period Extended........   08/09/13  78 FR 48636
NPRM Comment Period Extended End....   11/15/13
NPRM Comment Period Extended........   11/20/13  78 FR 69604
NPRM Comment Period Extended End....   11/22/13
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jenny Scott, Senior Advisor, Department of Health
and Human Services, Food and Drug Administration, Office of Food
Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240
402-1488, Email<EMAIL_ADDRESS>    RIN: 0910-AG36

286. ``Tobacco Products'' Subject to the Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco
Control Act

    Regulatory Plan: This entry is Seq. No. 52 in part II of this issue
of the Federal Register.
    RIN: 0910-AG38

287. Requirements for the Testing and Reporting of Tobacco Product
Constituents, Ingredients, and Additives

    Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 387; The Family
Smoking Prevention and Tobacco Control Act
    Abstract: The Federal Food, Drug, and Cosmetic Act, as amended by
the Family Smoking Prevention and Tobacco Control Act, requires the
Food and Drug Administration to promulgate regulations that require the
testing and reporting of tobacco product constituents, ingredients, and
additives, including smoke constituents, that the agency determines
should be tested to protect the public health.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/13
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Carol Drew, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 9200 Corporate Boulevard, Room 240 H, Rockville, MD
20850, Phone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>

    RIN: 0910-AG59

288. Foreign Supplier Verification Program

    Legal Authority: 21 U.S.C. 384a; title III, sec 301 of FDA Food
Safety Modernization Act, Pub. L. 111-353, establishing sec 805 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act)
    Abstract: FDA is proposing regulations that describe what a food
importer must do to verify that its foreign suppliers produce food that
is as safe as food produced in the United States. FDA is taking this
action to improve the safety of food that is imported into the United
States.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/29/13  78 FR 45729
NPRM Comment Period End.............   11/26/13  .......................
NPRM Comment Period Extended........   11/20/13  78 FR 69602
NPRM Comment Period Extended End....   01/27/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian L. Pendleton, Senior Policy Advisor,
Department of Health and Human Services, Food and Drug Administration,
Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue, Silver
Spring, MD 20993-0002, Phone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    RIN: 0910-AG64

289. Supplemental Applications Proposing Labeling Changes for Approved
Drugs and Biological Products

    Regulatory Plan: This entry is Seq. No. 55 in part II of this issue
of the Federal Register.
    RIN: 0910-AG94

290. Veterinary Feed Directive

    Regulatory Plan: This entry is Seq. No. 56 in part II of this issue
of the Federal Register.
    RIN: 0910-AG95

291. Format and Content of Reports Intended To Demonstrate Substantial
Equivalence

    Legal Authority: 21 U.S.C. 387e(j); 21 U.S.C. 387j(a); secs 905(j)
and 910(a) of the Federal Food, Drug, and Cosmetic Act
    Abstract: This regulation would establish the format and content of
reports intended to demonstrate substantial equivalence and compliance
with the FD&C Act (sections 905(j) and 910(a) of the FD&C Act). This
regulation also would provide information as to how the Agency will
review and act on these submissions.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gerie Voss, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 9200 Corporate Boulevard, Rockville, MD 20850, Phone:
877 287-1373, Fax:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0910-AG96

292. Radiology Devices; Designation of Special Controls for the
Computed Tomography X-Ray System

    Legal Authority: 21 U.S.C. 360
    Abstract: The proposed rule would establish special controls for
the computed tomography (CT) X-ray system, a class II device as defined
in 21 CFR 892.1750. A CT X-ray system is a diagnostic X-ray imaging
system intended to produce cross-sectional images of the body through
use of a computer to reconstruct an image from the same axial plane
taken at different angles. High doses of ionizing radiation can cause
acute (deterministic) effects such as burns, reddening of the skin,
cataracts, hair loss, sterility, or, in extremely high doses, radiation
poisoning. Therefore, the design of a CT X-ray system needs to balance
the benefits of the device (i.e., the ability of the device to produce
a diagnostic quality image) with the known risks (e.g., exposure to
ionizing radiation). FDA is establishing special controls, combined
with the general controls, to provide reasonable assurance of the
safety and effectiveness of a class II CT X-ray system.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Erica Blake, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4426, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone:<PHONE_NUMBER>, Fax: 301 847-
8145, Email<EMAIL_ADDRESS>    RIN: 0910-AH03

293. Mammography Quality Standards Act; Regulatory Amendments

    Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e);
42 U.S.C. 263b
    Abstract: FDA is proposing to amend its regulations governing
mammography. The amendments would update the regulations issued under
the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking
this action to address changes in mammography technology and
mammography processes, such as breast density reporting, that have
occurred since the regulations were published in 1997.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone:<PHONE_NUMBER>, Fax: 301 847-
8145, Email<EMAIL_ADDRESS>    RIN: 0910-AH04

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administrtion (FDA)

Final Rule Stage

294. Content and Format of Labeling for Human Prescription Drugs and
Biologics; Requirements for Pregnancy and Lactation Labeling

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21
U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42
U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264
    Abstract: This final rule will amend the content and format of the
``Pregnancy,'' ``Labor and delivery,'' and ``Nursing mothers''
subsections of the ``Use in Specific Populations'' section of
regulations regarding the labeling for human prescription drug and
biological products (21 CFR 201.56 and 201.57) to better communicate
risks.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/29/08  73 FR 30831

NPRM Comment Period End.............   08/27/08  .......................
Final Action........................   05/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Molly Flannery, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6246, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    RIN: 0910-AF11

295. Infant Formula: Current Good Manufacturing Practices; Quality
Control Procedures; Notification Requirements; Records and Reports; and
Quality Factors

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 350a; 21
U.S.C. 371
    Abstract: The Food and Drug Administration (FDA) is revising its
infant formula regulations in 21 CFR parts 106 and 107 to establish
requirements for current good manufacturing practices (CGMP), including
audits; to establish requirements for quality factors; and to amend
FDA's quality control procedures, notification, and record and
reporting requirements for infant formula. FDA is taking this action to
improve the protection of infants who consume infant formula products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/09/96  61 FR 36154
NPRM Comment Period End.............   12/06/96  .......................
NPRM Comment Period Reopened........   04/28/03  68 FR 22341
NPRM Comment Period Extended........   06/27/03  68 FR 38247
NPRM Comment Period End.............   08/26/03  .......................
NPRM Comment Period Reopened........   08/01/06  71 FR 43392
NPRM Comment Period End.............   09/15/06  .......................
Final Rule..........................   11/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Benson Silverman, Staff Director, Infant Formula
and Medical Foods, Department of Health and Human Services, Food and
Drug Administration, Center for Food Safety and Applied Nutrition (HFS-
850), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240
402-1459, Email<EMAIL_ADDRESS>    RIN: 0910-AF27

296. Combinations of Bronchodilators With Nasal Decongestants or
Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic
Drug Products for Over-the-Counter Human Use

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses cough/cold drug products containing an oral bronchodilator
(ephedrine and its salts) in combination with any expectorant or any
oral nasal decongestant.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Amendment)....................   07/13/05  70 FR 40232
NPRM Comment Period End.............   11/10/05  .......................
Final Action (Technical Amendment)..   03/19/07  72 FR 12730
Final Action........................   06/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Regulatory Health Project
Manager, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 22, Room
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-3713, Fax:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0910-AF33

297. Laser Products; Proposed Amendment to Performance Standard

    Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C.
393
    Abstract: FDA is proposing to amend the performance standard for
laser products to achieve closer harmonization between the current
standard and the International Electrotechnical Commission (IEC)
standard for laser products and medical laser products. The proposed
amendment is intended to update FDA's performance standard to reflect
advancements in technology.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/24/13  78 FR 37723
NPRM Comment Period End.............   09/23/13  .......................
Final Action........................   06/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone:<PHONE_NUMBER>, Fax: 301 847-
8145, Email<EMAIL_ADDRESS>    RIN: 0910-AF87

298. Food Labeling: Calorie Labeling of Articles of Food Sold in
Vending Machines

    Regulatory Plan: This entry is Seq. No. 57 in part II of this issue
of the Federal Register.
    RIN: 0910-AG56

299. Food Labeling: Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments

    Regulatory Plan: This entry is Seq. No. 58 in part II of this issue
of the Federal Register.
    RIN: 0910-AG57

300. Use of Certain Sysmbols in Labeling

    Legal Authority: sec 502(c) of the Food Drug and Cosmetic Act (FD&C
Act), 21 U.S.C. 352(c); sec 514(c) of FD&C Act, 21 U.S.C. 360d(c),
enacted by the Food and Drug Modernization Act of 1997 (FDAMA)
    Abstract: The purpose of this rule is to allow for the inclusion of
certain stand-alone symbols contained in a standard that FDA
recognizes, provided that such symbols are explained in a symbols
glossary that contemporaneously accompanies the medical device.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/19/13  78 FR 23508
NPRM Comment Period End.............   06/18/13  .......................
Final Action........................   04/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mary Follette Story, Human Factors and Accessible
Medical Technology Specialist, Department of Health and Human Services,
Food and Drug Administration, Center for Devices

and Radiological Health, Room 2553, 10903 New Hampshire Avenue, Silver
Spring, MD 20993, Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0910-AG74

301. Requirements for the Submission of Data Needed To Calculate User
Fees for Manufacturers and Importers of Tobacco Products

    Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387s; Pub. L. 111-31
    Abstract: FDA is proposing to require manufacturers and importers
of tobacco products to submit certain market share data to FDA. USDA
currently collects such data, but its program sunsets at the end of
September 2014 and USDA will cease collection of this information. FDA
is taking this action so that it may continue to calculate market share
percentages needed to compute user fees.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/31/13  78 FR 32581
NPRM Comment Period End.............   08/14/13  .......................
Final Action........................   06/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Annette L. Marthaler, Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Tobacco Products, Room 340K, 9200 Corporate Boulevard,
Rockville, MD 20850, Phone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    RIN: 0910-AG81

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

302. Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug
Products

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses antimicrobial agents in consumer hand wash products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Healthcare)...................   06/17/94  59 FR 31402
Comment Period End..................   12/15/95  .......................
NPRM (Consumer Hand Wash Products)..   12/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Eng, Regulatory Project Manager, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone:<PHONE_NUMBER>, Fax: 301 796-
9899, Email<EMAIL_ADDRESS>    RIN: 0910-AF69

303. Amendment to the Current Good Manufacturing Practice Regulations
for Pharmaceuticals--Second Phase

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C.
262; 42 U.S.C. 264
    Abstract: FDA will revise regulations for ``current good
manufacturing practice'' for oversight and controls over the
manufacture of drugs to ensure quality, including managing the risk of
and establishing the safety of raw materials, materials used in the
manufacturing of drugs, and finished drug products. This revision will
update and harmonize requirements and improve detection and response to
emerging product safety and quality signals.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Paula Katz, Regulatory Counsel, Office of
Compliance, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 51, Room
4314, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-6972, Fax:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0910-AG20

304. Human Subject Protection; Acceptance of Data From Clinical Studies
for Medical Devices

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21
U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C.
360i; 21 U.S.C. 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21
U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 271; * * *
    Abstract: This rule will amend FDA's regulations on acceptance of
data from clinical studies conducted in support of a premarket approval
application, humanitarian device exemption application, an
investigational device exemption application, or a premarket
notification submission for a medical device.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/25/13  78 FR 12664
NPRM Comment Period End.............   05/28/13  .......................
Final Action........................   12/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sheila Anne Brown, Policy Analyst, Investigational
Device Exemptions Staff, Department of Health and Human Services, Food
and Drug Administration, WO 66, Room 1651, 10903 New Hampshire Avenue,
Silver Spring, MD 20993, Phone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    RIN: 0910-AG48

305. Amendments to the Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals--Components

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 360bbb-7; 21 U.S.C. 371; 21
U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264
    Abstract: FDA will revise regulations for ``current good
manufacturing practice'' with regard to the control over components
used in manufacturing finished pharmaceuticals.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Hasselbalch, Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 4364, 10903 New
Hampshire Avenue,

Silver Spring, MD 20993, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    Paula Katz, Consumer Safety Officer, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, WO 51, Room 1320, 10903 New Hampshire Avenue, Silver Spring,
MD 20993, Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0910-AG70

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

306. Unique Device Identification

    Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21
U.S.C. 360h; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 360l; 21 U.S.C.
371
    Abstract: FDA is issuing a final rule establishing a unique device
identification system for medical devices. A unique device
identification system would allow healthcare professionals and others
to rapidly and precisely identify a device and obtain important
information concerning the device and would reduce medical errors.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/10/12  77 FR 40735
NPRM Comment Period End.............   11/07/12  .......................
Second NPRM.........................   11/19/12  77 FR 69393
Second NPRM Comment Period End......   12/19/13  .......................
Final Action........................   09/24/13  78 FR 58786
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: John J. Crowley, Senior Advisor for Patient Safety,
Department of Health and Human Services, Food and Drug Administration,
Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    RIN: 0910-AG31

307. Food Labeling: Serving Sizes; Reference Amount and Serving Size
Declaration for Hard Candies and Breath Mints

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
    Abstract: FDA is proposing to change the nutrition label serving
size for breath mints to one unit. FDA is taking this action in
response to a citizen petition that requested a serving size for breath
mints that more accurately reflects the amount customarily consumed per
eating occasion and comments received on an advance notice of proposed
rulemaking published in 2005.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/30/97  62 FR 67775
NPRM Comment Period End.............   03/16/98  .......................
ANPRM...............................   04/05/05  70 FR 17010
ANPRM Comment Period End............   06/20/05  .......................
Withdrawn and Merged with 0910-AF23.   08/14/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mark Kantor, Nutritionist, Department of Health and
Human Services, Food and Drug Administration, HFS-830, 5100 Paint
Branch Parkway, College Park, MD 20740, Phone:<PHONE_NUMBER>, Fax: 301
436-1191, Email<EMAIL_ADDRESS>    RIN: 0910-AG82

308. Food Labeling; Gluten-Free Labeling of Foods

    Legal Authority: Title II of Pub. L. 108-282; 21 U.S.C. 321; 21
U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371
    Abstract: FDA is amending its regulations to define the term
``gluten-free'' for voluntary use in the labeling of foods. FDA is
taking this action to assist persons who have celiac disease to more
easily identify foods that they can eat while following a ``gluten-
free'' diet.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/23/07  72 FR 2795
NPRM Comment Period End.............   04/23/07  .......................
NPRM Comment Period Reopened........   08/03/11  76 FR 46671
NPRM Comment Period Reopened End....   10/03/11  .......................
Final Action........................   08/05/13  78 FR 47154
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Felicia Billingslea, Director, Food Labeling and
Standard Staff, Department of Health and Human Services, Food and Drug
Administration, Room 4D045, HFS 820, 5100 Paint Branch Parkway, College
Park, MD 20740, Phone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    RIN: 0910-AG84

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

309. Emergency Preparedness Requirements for Medicare and Medicaid
Participating Providers and Suppliers (CMS-3178-P) (Section 610 Review)

    Legal Authority: 42 U.S.C. 1821; 42 U.S.C. 1861 (ff) (3)(B)(i)(ii);
42 U.S.C. 1913 (c)(1) et al
    Abstract: This rule proposes emergency preparedness requirements
for Medicare and Medicaid participating providers and suppliers to
ensure that they adequately plan for both natural and man-made
disasters and coordinate with Federal, State, tribal, regional, and
local emergency preparedness systems. This rule would ensure providers
and suppliers are adequately prepared to meet the needs of patients,
residents, clients, and participants during disasters and emergency
situations.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Graham, Health Insurance Specialist, Clincal
Standards Group, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Center for Clincial Standards and
Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD
21244-1850, Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0938-AO91

310. Prospective Payment System for Federally Qualified Health Centers;
Changes to Contracting Policies for Rural Health Clinics and CLIA
Enforcement Actions for Proficiency Testing Referral (CMS-1443-F)
(Section 610 Review)

    Legal Authority: Pub. L. 111-148, sec 10501
    Abstract: This final rule establishes methodology and payment rates
for a prospective payment system (PPS) for federally qualified health
center (FQHC)

services under Medicare Part B beginning on October 1, 2014, in
compliance with the statutory requirement of the Affordable Care Act.
This rule also establishes a policy which would allow rural health
clinics (RHCs) to contract with nonphysician practitioners when
statutory requirements for employment of nurse practitioners and
physician assistants are met, and makes other technical and conforming
changes to the RHC and FQHC regulations. Finally, this rule makes
changes to the Clinical Laboratory Improvement Amendments (CLIA)
regulations regarding enforcement actions for proficiency testing
referral.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/23/13  78 FR 58386
NPRM Comment Period End.............   11/18/13  .......................
Final Action........................   08/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sarah Harding, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C4-01-26, 7500 Security Boulevard, Windsor
Mill, MD 21244, Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0938-AR62

311.  Hospital Inpatient Prospective Payment System for Acute
Care Hospitals and the Long-Term Care Hospital Prospective Payment
System and Fiscal Year 2015 Rates (CMS-1607-P)

    Regulatory Plan: This entry is Seq. No. 62 in part II of this issue
of the Federal Register.
    RIN: 0938-AS11

312.  CY 2015 Revisions to Payment Policies Under the Physician
Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P)

    Regulatory Plan: This entry is Seq. No. 63 in part II of this issue
of the Federal Register.
    RIN: 0938-AS12

313.  CY 2015 Hospital Outpatient Prospective Payment System
(PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical
Center Payment System Policy Changes and Payment Rates (CMS-1613-P)

    Regulatory Plan: This entry is Seq. No. 64 in part II of this issue
of the Federal Register.
    RIN: 0938-AS15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

314. Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review)

    Legal Authority: Pub. L. 111-48, secs 2501, 2503, 3301(d)(2); Pub.
L. 111-152, sec 1206; Pub. L. 111-8, sec 221
    Abstract: This final rule revises requirements pertaining to
Medicaid reimbursement for covered outpatient drugs to implement
provisions of the Affordable Care Act. This rule also revises other
requirements related to covered outpatient drugs, including key aspects
of Medicaid coverage, payment, and the drug rebate program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/02/12  77 FR 5318
NPRM Comment Period End.............   04/02/12  .......................
Final Action........................   05/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Wendy Tuttle, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicaid and State Operations, Mail Stop
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8690, Email<EMAIL_ADDRESS>    RIN: 0938-AQ41

315. CY 2014 Changes to the End-Stage Renal Disease (ESRD) Prospective
Payment System, ESRD Quality Incentive Program, and Durable Medical
Equipment (CMS-1526-F)

    Legal Authority: MIPPA sec 153(b); Pub. L. 111-148 sec 3401(h);
ATRA sec 632(a)
    Abstract: This final rule updates the bundled payment system for
End Stage Renal Disease (ESRD) facilities by 1/1/13. The rule also
updates the Quality Incentives in the ESRD Program. In addition, this
rule clarifies the grandfathering provision related to the 3-year
minimum lifetime requirement for Durable Medical Equipment (DME). It
also provides clarification of the definition of routinely purchased
DME.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/08/13  78 FR 40835
NPRM Comment Period End.............   08/30/13  .......................
Final Action........................   11/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michelle Cruse, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Mailstop C5-05-27,
Baltimore, MD 21244, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    RIN: 0938-AR55

316. Revisions to Payment Policies Under the Physician Fee Schedule and
Medicare Part B for CY 2014 (CMS-1600-F)

    Legal Authority: Social Security Act secs 1102, 1871, 1848
    Abstract: This final rule revises payment polices under the
Medicare physician fee schedule, and make other policy changes to
payment under Medicare Part B. These changes are applicable to services
furnished on or after January 1 annually.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/19/13  78 FR 43282
NPRM Comment Period End.............   09/06/13  .......................
Final Action........................   11/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Kathy Bryant, Deputy Director, Division of
Practitioner Services, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Mail Stop C4-01-27, 7500 Security
Boulevard, Baltimore, MD 21244, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    RIN: 0938-AR56

317.  Adoption of Operating Rules for HIPAA Transactions (CMS-
0036-IFC)

    Legal Authority: Pub. L. 104-191, sec 1104
    Abstract: Under the Affordable Care Act, this interim final rule
adopts operating rules for HIPAA transactions for health care claims or
equivalent encounter information, enrollment and disenrollment of a
health plan, health plan premium payments, and referral certification
and authorization.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   06/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Christine Stahlecker, Acting Director,
Administrative Simplification Group, Office of E-Health Standards and
Services, Department of

Health and Human Services, Centers for Medicare & Medicaid Services,
Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244,
Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    RIN: 0938-AS01

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

318. Changes to the Hospital Inpatient and Long-Term Care Prospective
Payment System for FY 2014 (CMS-1599-F)

    Legal Authority: sec 1886(d) of the Social Security Act
    Abstract: This annual rule revises the Medicare hospital inpatient
and long-term care hospital prospective payment systems for operating
and capital-related costs. This rule implements changes arising from
our continuing experience with these systems.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/10/13  78 FR 27485
NPRM Comment Period End.............   06/25/13  .......................
Final Action........................   08/19/13  78 FR 50419
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Roechel Kujawa, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C4-07-07, 7500 Security Boulevard,
Baltimore, MD 21244, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    RIN: 0938-AR53

319. Changes to the Hospital Outpatient Prospective Payment System and
Ambulatory Surgical Center Payment System for CY 2014 (CMS-1601-F)

    Legal Authority: sec 1833 of the Social Security Act
    Abstract: This final rule revises the Medicare hospital outpatient
prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system. The rule also describes changes to the amounts and factors
used to determine payment rates for services. In addition, the rule
finalizes changes to the Ambulatory Surgical Center Payment System list
of services and rates.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/19/13  78 FR 43534
NPRM Comment Period End.............   09/06/13  .......................
Final Action........................   09/06/13  78 FR 54842
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Marjorie Baldo, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare Management, Mail Stop C4-03-06,
7500 Security Boulevard, Baltimore, MD 21244, Phone:<PHONE_NUMBER>,
Email<EMAIL_ADDRESS>    RIN: 0938-AR54

[FR Doc. 2013-29632 Filed 1-6-14; 8:45 am]
BILLING CODE 4150-24-P


[Federal Register Volume 81, Number 163 (Tuesday, August 23, 2016)]
[Proposed Rules]
[Pages 57531-57534]
[FR Doc No: 2016-20143]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2016-0335; FRL-9951-13-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Adoption of Control Techniques Guidelines for Control of
Volatile Organic Compound Emissions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve state implementation plan (SIP) revisions submitted by the
Commonwealth of Virginia (Virginia). These revisions include amendments
to the Virginia Department of Environmental Quality's (VADEQ)
regulations and address the requirement to adopt Reasonably Available
Control Technology (RACT) for sources covered by EPA's Control
Techniques Guidelines (CTG) standards for the following categories:
Offset lithographic printing and letterpress printing, industrial
solvent cleaning operations, miscellaneous industrial adhesives, and
miscellaneous metal and plastic parts coatings. This action is being
taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before September 22,
2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2016-0335 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Leslie Jones Doherty,<PHONE_NUMBER>,
or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On February 1, 2016, Virginia, through the
VADEQ, submitted three revisions to the Virginia SIP concerning the
adoption of EPA CTGs for offset lithographic printing and letterpress
printing, industrial solvent cleaning operations, miscellaneous
industrial adhesives, and miscellaneous metal and plastic parts
coatings sources in the specific portion of Virginia known as the
Northern Virginia Volatile Organic Compound Emissions Control Area.

I. Background

    On March 27, 2008, EPA revised the 8-hour ozone standard to a new
0.075 parts per million (ppm) level (73 FR 16436). On May 21, 2012, EPA
finalized designations for the 2008 8-hour ozone NAAQS (77 FR 30087) in
which the Washington, DC-MD-VA area was designated marginal
nonattainment. See 40 CFR 81.347. Section 172(c)(1) of the CAA provides
that SIPs for nonattainment areas must include reasonably available
control measures (RACM), including RACT, for sources of emissions.\1\
However, the northern portion of Virginia is also part of the
Metropolitan Statistical Area of the District Columbia which is in the
ozone transport region (OTR) established under section 184(a) of the
CAA. Pursuant to section 184(b)(1)(B) of the CAA, all areas in the OTR
must implement RACT with respect to sources of volatile organic
compounds (VOCs) in the state covered by a CTG issued before or after
November 15, 1990. In addition, pursuant to CAA section 184(b)(2),
stationary sources in states or portions of a state within the OTR that
emit at least 50 tons per year of VOCs shall be considered major
stationary sources subject to requirements applicable to major
stationary sources if the area were classified as a Moderate
nonattainment area including requirements for CTGs and RACT.
---------------------------------------------------------------------------

    \1\ EPA defines RACT as ``the lowest emission limitation that a
particular source is capable of meeting by the application of
control technology that is reasonably available considering
technological and economic feasibility.'' 44 FR 53761 (September 17,
1979).

---------------------------------------------------------------------------

    Thus, Virginia must implement for its SIP RACT with respect to
sources of VOCs covered by CTGs in the northern portion of Virginia
that is part of the Metropolitan Statistical Area of the District
Columbia and within the OTR (which Virginia refers to as the ``Northern
Virginia Volatile Organic Compound Emissions Control Area'').\2\ CAA
section 184(b)(1)(B) and (2).
---------------------------------------------------------------------------

    \2\ The northern portion of Virginia is defined as the Northern
Virginia Volatile Organic Compound Emissions Control Area in 9VAC5-
20-206 (General Provisions).
---------------------------------------------------------------------------

    CTGs are documents issued by EPA intended to provide state and
local air pollution control authorities information to assist them in
determining RACT for VOC from various sources. Section 183(e)(3)(c)
provides that EPA may issue a CTG in lieu of a national regulation as
RACT for a product category where EPA determines that the CTG will be
substantially as effective as regulations in reducing emissions of VOC
in ozone nonattainment areas. The recommendations in the CTG are based
upon available data and information and may not apply to a particular
situation based upon the circumstances. States can follow the CTG and
adopt state regulations to implement the recommendations contained
therein, or they can adopt alternative approaches. In either case,
states must submit their RACT rules to EPA for review and approval as
part of the SIP process.
    In 1993, EPA published a draft CTG for offset lithographic printing
(58 FR 59261). After reviewing comments on the draft CTG and soliciting
additional information to help clarify those comments, EPA published an
alternative control techniques (ACT) document in June 1994 that
provided supplemental information for states to use in developing rules
based on RACT for offset lithographic printing. In 1994, EPA developed
an ACT document for industrial cleaning solvents. No previous EPA
actions have been taken regarding miscellaneous industrial adhesives
application operations. In 1978, EPA published a CTG for miscellaneous
metal parts and products and in 1994 EPA published an ACT for the
coating of automotive/transportation and business machine plastic parts
surface coatings. After reviewing the 1978 and 1993 CTGs and 1994 ACTs
for these industries, conducting a review of currently existing state
and local VOC emission reduction approaches for these industries, and
taking into account any information that has become available since
then, EPA developed new CTGs entitled Control Techniques Guidelines for
Offset Lithographic and Letterpress Printing (Publication No. EPA 453/
R-06-002; September 2006); Control Techniques Guidelines for Industrial
Cleaning Solvents (Publication No. EPA 453/R-06-001; September 2006);
Control Techniques Guidelines for Miscellaneous Industrial Adhesives
(Publication No. EPA 453/R-08-005; September 2008); and Control
Techniques Guidelines for Miscellaneous Metal and Plastic Parts
Coatings (Publication No. EPA 453/R-08-003; September 2008). The CTG
recommendations may not apply to a particular situation based upon the
circumstances of a specific source. Regardless of whether a state
chooses to implement the recommendations contained within the CTGs
through state rules, or to issue state rules that adopt different
approaches for RACT for VOCs, states must submit their RACT rules to
EPA for review and approval as part of the SIP process.

II. Summary of SIP Revisions and EPA Analysis

    On February 1, 2016, Virginia, through the VADEQ, submitted three
revisions to the Virginia SIP concerning the adoption of the EPA CTGs
for offset lithographic printing and letterpress printing, industrial
solvent cleaning operations, miscellaneous industrial adhesives, and
miscellaneous metal and plastic parts coatings in the Northern Virginia
Volatile Organic Compound Emissions Control Area. These regulations are
contained in the following Articles in regulation 9VAC5 Chapter 40,
Existing Stationary Sources: Article 56, Emission Standards for
Letterpress Printing Operations in the Northern Virginia Volatile
Organic Compound Emissions Control Area, 8-Hour Ozone Standard; Article
56.1, Emission Standards for Offset Lithographic Printing Operations in
the Northern Virginia Volatile Organic Compound Emissions Control Area,
8-Hour Ozone Standard; Article 57, Emission Standards for Industrial
Solvent Cleaning Operations in the Northern Virginia Volatile Organic
Compound Emissions Control Area, 8-Hour Ozone Standard; Article 58,
Emission Standards for Miscellaneous Industrial Adhesive Application
Processes in the Northern Virginia Volatile Organic Compound Emissions
Control Area, 8-Hour Ozone Standard; and Article 59, Emission Standards
for Miscellaneous Metal Parts and Products Coating Application Systems
in the Northern Virginia Volatile Organic Compound Emissions Control
Area, 8-Hour Ozone Standard. These regulations: (1) Establish
applicability for offset lithographic printing and letterpress
printing, industrial cleaning solvent operations, miscellaneous
industrial adhesives, and miscellaneous metal and plastic parts
coatings at facilities; (2) establish exemptions; (3) establish
emission limitations and work practice requirements; and (4) establish
monitoring, notification, record-keeping and reporting requirements.
    The SIP revisions also amend regulations 9VAC5 Chapter 40, Existing
Stationary Sources, Article 34 and Article 53. In regulation 9VAC5
Chapter 40, Article 34, Emission Standards for Miscellaneous Metal
Parts and Products Coating Application Systems, section 4760, was
amended to exempt VOC sources in the Northern Virginia Volatile Organic
Compound Emissions Control Area from its provisions. See 9VAC5-40-4760.
On and after February 1, 2017, these sources are subject to Article 59,
Emission Standards for Miscellaneous Metal Parts and Products Coating
Application Systems in the Northern Virginia Volatile Organic Compound
Emissions Control Area, 8-Hour Ozone Standard. Regulation 9VAC5 Chapter
40, Article 53, Emission Standards for Lithographic Printing Processes,
section 7800, was amended to exempt offset lithographic printing
processes from its provisions and refers applicable facilities to the
provisions in Article 56.1, Emission Standards for Offset Lithographic
Printing Operations in the Northern Virginia Volatile Organic Compound
Emissions Control Area, 8-Hour Ozone Standard. See 9VAC5-40-7800.
Virginia has also amended supporting definitions in 9VAC5, Chapter 20,
General Provisions which relate to the new CTG standards.
    EPA's review of the new and revised regulations submitted by VADEQ
finds that the submitted revisions of regulation 9VAC5, Chapter 40,
Existing Stationary Sources, and 9VAC5, Chapter 20, General Provisions,
address the requirements to adopt RACT for sources located in Virginia
covered by EPA's CTG recommendations for control of VOC emissions in
accordance with CAA section 184(b)(1)(B) and (2) for the following
categories: Offset lithographic printing and letterpress printing,
industrial cleaning solvent operations, miscellaneous industrial
adhesives, and miscellaneous metal and plastic parts coatings. EPA also
finds the Virginia regulations, which adopt the equivalent of the
specific EPA CTG recommendations, address CAA requirements for RACT in
sections 172 and 182 as referenced by section 184. More detailed
information on these provisions as well as a detailed summary of EPA's
review and rationale

for proposing to approve these SIP revisions can be found in the
Technical Support Document (TSD) for this action which is available on
line at www.regulations.gov, Docket number EPA-R03-OAR-2016-0335.

III. Proposed Action

    EPA is proposing to approve the Virginia SIP revisions submitted on
February 1, 2016, which consist of amendments to regulation 9VAC5
Chapter 40, Existing Stationary Sources and 9VAC5 Chapter 20, General
Provisions, and address the requirement to adopt RACT for sources
located in the Northern Virginia VOC Emissions Control Area covered by
EPA's CTG standards in accordance with CAA requirements in sections
172, 182 and 184 for the following categories: Offset lithographic
printing and letterpress printing, industrial cleaning solvent
operations, miscellaneous industrial adhesives, and miscellaneous metal
and plastic parts coatings. EPA is soliciting public comments on the
issues discussed in this document. These comments will be considered
before taking final action.

IV. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information that: (1) Are generated or developed
before the commencement of a voluntary environmental assessment; (2)
are prepared independently of the assessment process; (3) demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
federally authorized environmental programs in a manner that is no less
stringent than their federal counterparts. . . .'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by federal law to maintain program delegation, authorization or
approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on federal
enforcement authorities, EPA may at any time invoke its authority under
the CAA, including, for example, sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort. In addition, citizen
enforcement under section 304 of the CAA is likewise unaffected by
this, or any, state audit privilege or immunity law.

V. Incorporation by Reference

    In this proposed rulemaking action, EPA is proposing to include in
a final EPA rule, regulatory text that includes incorporation by
reference. In accordance with requirements of 1 CFR 51.5, EPA is
proposing to incorporate by reference the VADEQ regulations regarding
control of VOC emissions from offset lithographic printing and
letterpress printing, industrial solvent cleaning operations,
miscellaneous industrial adhesives, and miscellaneous metal and plastic
parts coatings in the Northern Virginia Volatile Organic Compound
Emissions Control Area as described in section II of this proposed
action. EPA has made, and will continue to make, these materials
generally available through http://www.regulations.gov and/or at the
EPA Region III Office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this proposed action:
     is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or

safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land as
defined in 18 U.S.C. 1151 or in any other area where EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the RACT rules for sources in northern Virginia in this
action do not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: August 10, 2016.
Shawn M. Garvin,
Regional Administrator, Region III.
[FR Doc. 2016-20143 Filed 8-22-16; 8:45 am]
 BILLING CODE 6560-50-P