[Federal Register Volume 84, Number 90 (Thursday, May 9, 2019)]
[Notices]
[Pages 20367-20368]
[FR Doc No: 2019-09528]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4525]

Clinical Lactation Studies: Considerations for Study Design;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Clinical
Lactation Studies: Considerations for Study Design.'' This guidance
reflects FDA's current recommendations to sponsors regarding lactation
studies during drug development. This guidance provides recommendations
to facilitate the conduct of lactation studies. Such studies can inform
breastfeeding with drug use recommendations included in the Lactation
subsection of labeling. The recommendations in this guidance also
reflect discussions from the 2007 Pediatric Advisory Committee meeting
and the 2016 Lactation Workshop, which considered how data from
clinical lactation studies can inform the safety of a drug when used
during lactation. This guidance replaces the draft guidance for
industry entitled ``Clinical Lactation Studies--Study Design, Data
Analysis, and Recommendations for Labeling'' issued February 2005.

DATES: Submit either electronic or written comments on the draft
guidance by July 8, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-4525 for ``Clinical Lactation Studies: Considerations for
Study Design.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the

claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jian Wang, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Avenue,
Bldg. 22, Rm 5309, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Clinical Lactation Studies: Considerations for Study
Design.'' This guidance reflects FDA's current recommendations
regarding lactation studies during drug development. This guidance
provides recommendations to facilitate the conduct of lactation
studies. Such studies can inform breastfeeding with drug use
recommendations included in the Lactation subsection of labeling. The
recommendations in this guidance also reflect discussions at the 2007
Pediatric Advisory Committee meeting (see https://wayback.archive-it.org/7993/20170403222238/https://www.fda.gov/ohrms/dockets/ac/oc07.htm#pac) and the 2016 Lactation Workshop (see https://www.fda.gov/Drugs/NewsEvents/ucm486761.htm), which considered how data from
clinical lactation studies can inform the safety of a drug when used
during lactation. However, this guidance does not address specific
lactation labeling recommendations because these topics are addressed
in 21 CFR 201.57(c)(9)(ii) and the draft guidance for industry
``Pregnancy, Lactation, and Reproductive Potential: Labeling for Human
Prescription Drug and Biological Products--Content and Format''
(available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm425398.pdf). This guidance replaces the
draft guidance for industry entitled ``Clinical Lactation Studies--
Study Design, Data Analysis, and Recommendations for Labeling'' issued
February 8, 2005 (70 FR 6697).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Clinical
Lactation Studies: Considerations for Study Design.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in 21 CFR part 314, including the submission
of labeling under Sec. Sec.  314.50(e)(2)(ii) and 314.50(l)(1)(i), has
been approved under OMB control number 0910-0001. The submission of
prescription drug labeling under Sec. Sec.  201.56 and 201.57 has been
approved under OMB control number 0910-0572. The collection of
information in 21 CFR part 312 has been approved under OMB control
number 0910-0014. The collections of information in 21 CFR parts 50 and
56 (Protection of Human Subjects: Informed Consent; Institutional
Review Boards) have been approved under OMB control number 0910-0755.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: May 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09528 Filed 5-8-19; 8:45 am]
 BILLING CODE 4164-01-P


Comment Info: =================

General Comment:

Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.                                                                                I was smoking for 30 years. In 2011 I stopped smoking with the help of ecigs. In fact I only smoked two Cigarettes since I started vaping. After 1 month of vaping I smoked half of a Cigarette when my battery died. I bought more batteries.  After three mouths of vaping I tried a cigarette to see what it would be like. I could not stand it. After one draw I got rid of it. I  never smoked another cigarette since. My mother had COPD from smoking. She passed away due to smoking in November 2010. I started having real problems from smoking in 2009. I had breathing problems. I could not even bend over to tie my shoes without losing my breath, I got dizzy at times breathing hard. I had a very hard time passing a Respirator test, almost losing my job. I also started getting sick a lot (Sinus/Chest Infections) from smoking. I was so bad I told my wife after the death of my mother that If I can not stop smoking I may die in 5-10 years but not before getting very ill with COPD. But In June 2011. I found something that Changed my life. I found ecigs. Its 2014 Now. I still vape. My breathing is normal again. I can run again. I can swim again My blood pressure is now on the low side of normal. I passed a deep check blood test. All normal. No longer getting sick from smoking. I stopped smoking Cigarettes because I am using ecigs. As long that I can vape e-cigs I will no longer smoke Cigarettes. The FDA registration requirement is a business closer. The FDA should partners up with AEMSA  (American E-liquid Manufacturing Standard Association). Allowing only E-liquid that is certified by AEMSA to be sold in the United States. I only use e-liquid that is certified by AEMSA.


ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEI-2010-0835; FRL-    - ]

Agency Information Collection Activities; Proposed Collections; Toxic
Chemical Release

Reporting; Request for Comments on Proposed Renewal of Form R and Form
A, Including Minor Form Revisions  (EPA ICR No. 1363.21, OMB Control No.
2025-0009) and the Ratio-Based Burden Methodology

AGENCY:	Environmental Protection Agency

ACTION:	Notice.

SUMMARY:	In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C.
3501 et seq.),  EPA is planning to submit a request to renew an existing
approved Information Collection Request (ICR) to the Office of
Management and Budget (OMB). This ICR is scheduled to expire on July 31,
2011. The ICR Supporting Statement, which is summarized below and also
posted in the docket, along with a technical document titled “Revising
TRI Burden to Ratio-Based Methodology,” describes the nature of the
information collection (including proposed form changes) and its
estimated burden and cost. Before submitting the ICR to OMB for review
and approval, EPA is soliciting comments on specific aspects of the
proposed information collection as described below.

DATES: Comments must be submitted on or before [insert date 60 days
after publication in the Federal Register].

ADDRESSES:  Submit your comments, referencing Docket ID No.
EPA-HQ-OEI-2010-0835, by one of the following methods:

U.S. Government Web site for Federal Rulemaking, follow the on-line
instructions for submitting comments.

E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>,

Fax:<PHONE_NUMBER>.

Mail:  Office of Environmental Information (OEI) Docket, U.S.
Environmental Protection Agency, Mail Code 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.

Hand Delivery:  Public Reading Room, EPA West Building, Room 3334, 1301
Constitution Avenue, NW., Washington, DC 20004. Such deliveries are only
accepted during the docket's normal hours of operations, 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. Special
arrangements should be made for deliveries of boxed information.

Instructions:  To submit a comment to the docket, direct your comments
to Docket ID No. EPA-HQ-OEI-2010-0835. EPA's policy is that all comments
received will be included in the public docket without change and will
be made available online at   HYPERLINK "www.regulations.gov"
www.regulations.gov , including any personal information that has been
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information for which
disclosure is restricted by statute. Do not submit information that is
considered to be CBI or otherwise protected information through
HYPERLINK "www.regulations.gov"  www.regulations.gov  or e-mail. The
HYPERLINK "www.regulations.gov"  www.regulations.gov  Web site is an
“anonymous access” system, which means that EPA will not know your
identity or contact information unless you provide it in the body of
your comments. If you send an e-mail comment directly to EPA without
going through   HYPERLINK "www.regulations.gov"  www.regulations.gov ,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. When
preparing electronic files, avoid using special characters or any form
of encryption and ensure that the electronic files to be submitted are
free of any defects or viruses. For additional information about EPA's
public docket visit the EPA Docket Center homepage at   HYPERLINK
"www.epa.gov/epahome/dockets.htm"  www.epa.gov/epahome/dockets.htm .

FOR FURTHER INFORMATION CONTACT:  Cassandra Vail, Toxics Release
Inventory Program Division, Office of Information Analysis and Access
(2844T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number,<PHONE_NUMBER>; email address,
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

 SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

	EPA has established a public docket for the ICR described in this
notice under Docket ID No. EPA-HQ-OEI-2010-0835, which is available for
online viewing at   HYPERLINK "www.regulations.gov"  www.regulations.gov
. Go to   HYPERLINK "www.regulations.gov"  www.regulations.gov  to
obtain a copy of the proposed collection of information, to submit or
view public comments, to obtain an index of the docket contents, and to
obtain those documents in the public docket that are available
electronically. Once in the system, select "search," then enter the
docket ID number identified in this document.

	The docket is also available for viewing in person at the OEI Docket,
EPA Docket Center (EPA/DC), U.S. EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The phone number for the Reading Room is<PHONE_NUMBER>,
and the phone number for the OEI Docket is<PHONE_NUMBER>.

In Which Information Is EPA Particularly Interested?

	Pursuant to section 3506(c)(2)(a) of the Paperwork Reduction Act (PRA),
EPA specifically solicits comments and information to enable it to:

1.	Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the Agency, including
whether the information will have practical utility;

2.	Evaluate the accuracy of the Agency's estimate of the burden of the
proposed collection of information, including the validity of the new
Ratio-Based Burden Methodology;

3.	Enhance the quality, utility, and clarity of the information to be
collected; and

4.	Minimize the burden of the collection of information on those who are
to respond,        including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting the electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

            You may find the following suggestions helpful for preparing
your comments:

Explain your views as clearly as possible and provide specific examples;

Describe any assumptions that you used;

Provide copies of any technical information and/or data you used that
support your views;

If you provide estimates of potential burden hours or labor costs,
explain how you arrived at your estimates;

Offer alternative ways to improve the collection activity;

Make sure to submit your comments by the deadline identified under
DATES; and

To ensure proper receipt by EPA, identify the docket ID number assigned
to this action in the subject line on the first page of your response.
You may also provide the name, date, and Federal Register citation.

What Information Collection Activity or ICR Does This Apply to?

Affected Entities:  This ICR applies to facilities that submit annual
reports under section 313 of the Emergency Planning and Community
Right-to-Know Act (EPCRA) and section 6607 of the Pollution Prevention
Act (PPA).  The applicability criteria are outlined in part 372, subpart
B, of Title 40 of the Code of Federal Regulations, and potentially
affected categories and entities may include, but are not limited to the
following:

Category	Examples of Potentially Affected Entities

Industry	Facilities included in the following NAICS manufacturing codes
(corresponding to SIC codes 20 through 39): 311*, 312*, 313*, 314*,
315*, 316, 321, 322, 323*, 324, 325*, 326*, 327, 331, 332, 333, 334*,
335*, 336, 337*, 339*, 111998*, 211112*, 212324*, 212325*, 212393*,
212399*, 488390*, 511110, 511120, 511130, 511140*, 511191, 511199,
512220, 512230*, 519130*, 541712*, or 811490*.

*Exceptions and/or limitations exist for these NAICS codes.

Facilities included in the following NAICS codes (corresponding to SIC
codes other than SIC codes 20 through 39): 212111, 212112, 212113
(correspond to SIC 12, Coal Mining (except 1241)); or 212221, 212222,
212231, 212234, 212299 (correspond to SIC 10, Metal Mining (except 1011,
1081, and 1094)); or 221111, 221112, 221113, 221119, 221121, 221122,
221330 (Limited to facilities that combust coal and/or oil for the
purpose of generating power for distribution in commerce) (correspond to
SIC 4911, 4931, and 4939, Electric Utilities); or 424690, 425110, 425120
(Limited to facilities previously classified in SIC 5169, Chemicals and
Allied Products, Not Elsewhere Classified); or 424710 (corresponds to
SIC 5171, Petroleum Bulk Terminals and Plants); or 562112 (Limited to
facilities primarily engaged in solvent recovery services on a contract
or fee basis (previously classified under SIC 7389, Business Services,
NEC)); or 562211, 562212, 562213, 562219, 562920 (Limited to facilities
regulated under the Resource Conservation and Recovery Act, subtitle C,
42 U.S.C. 6921 et seq.) (correspond to SIC 4953, Refuse Systems).

Federal

Government	Federal facilities

If you have questions regarding the applicability of this action to a
particular entity, consult the individual listed in the preceding FOR
FURTHER INFORMATION CONTACT section.

Title:  Toxic Chemical Release Reporting (Form R); Toxic Chemical
Release Reporting, Alternate Threshold for Low Annual Reportable Amounts
(Form A) and the Ratio-Based Burden Methodology

ICR Numbers:  EPA ICR No. 1363.21, OMB Control No. 2025-0009 (TRI Form
R) and EPA ICR No. 1704.13, OMB Control No. 2025-0010 (TRI Form A
Certification Statement).  EPA proposes to combine these two ICRs into
one overarching ICR, which will retain the OMB Control No. 2025-0009.

ICR Status:  The ICRs for the TRI Form R and the TRI Form A
Certification Statement are scheduled to expire on July 31, 2011.

Abstract:  Pursuant to section 313 of EPCRA, certain facilities that
manufacture, process, or otherwise use specified toxic chemicals in
amounts above reporting threshold levels must submit annually to EPA and
to designated State officials toxic chemical release forms containing
information specified by EPA. 42 U.S.C. 11023. In addition, pursuant to
section 6607 of the Pollution Prevention Act (PPA), facilities reporting
under section 313 of EPCRA must also report pollution prevention and
waste management data, including recycling information, for such
chemicals. 42 U.S.C. 13106. These reports are compiled and stored in
EPA’s database known as the Toxics Release Inventory (TRI); TRI data
are made readily available to the public.

	Regulations at 40 CFR part 372, subpart B, require facilities that meet
all of the following criteria to report:

The facility has 10 or more full-time employee equivalents (i.e., a
total of 20,000 hours worked per year or greater; see 40 CFR 372.3); and

The facility is included in a North American Industry Classification
System (NAICS) Code listed at 40 CFR 372.23 or under Executive Order
13148, Federal facilities regardless of their industry classification;
and

The facility manufactures (defined to include importing), processes, or
otherwise uses any EPCRA section 313 (TRI) chemical in quantities
greater than the established thresholds for the specific chemical in the
course of a calendar year.

    	Facilities that meet the criteria must file a Form R report or, in
some cases, may submit a Form A Certification Statement, for each listed
toxic chemical for which the criteria are met. As specified in EPCRA
section 313(a), the report for any calendar year must be submitted on or
before July 1st of the following year. For example, reporting year 2009
data should have been submitted and certified on or before July 1, 2010.

	The list of toxic chemicals subject to TRI reporting can be found at 40
CFR 372.65. This list is also published every year as Table II in the
current version of the Toxics Release Inventory Reporting Forms and
Instructions. The current TRI chemical list contains 593 chemicals and
30 chemical categories.

	TRI data are used by environmental agencies, industry, and the public.
EPA program offices use TRI data, along with other data, to help
establish programmatic priorities, evaluate potential hazards to human
health and the natural environment, and undertake appropriate regulatory
and/or enforcement activities. Environmental and public interest groups
use the data to better understand toxic chemical releases at the
community level and to work with industry, government agencies, and
others to promote reductions in toxic chemical releases. Industrial
facilities use the TRI data to evaluate the efficiency of their
production processes and to help track and communicate their progress in
achieving pollution prevention goals.

	The TRI data are unique in providing a multi-media (air, water, and
land) picture of toxic chemical releases, transfers, and other waste
management activities by covered facilities on a yearly basis. While
other environmental media programs provide some toxic chemical data and
related permit data, the data are not directly comparable to TRI data
with regard to the types of chemicals and industry sectors that are
covered or the frequency of reporting.  Facilities that are subject to
TRI reporting must submit reports for each calendar year to EPA and the
States in which they are located by July 1st of the following year.

	Respondents may claim trade secrecy for a chemical's identity as
described in EPCRA Section 322 and its implementing regulations in 40
CFR part 350. EPA will disclose information that is covered by a claim
of trade secrecy only to the extent permitted by and in accordance with
the procedures in 40 CFR part 350 and 40 CFR part 2.

	An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in 40 CFR are listed in 40 CFR part 9 and are identified on the form
and/or instrument, if applicable.

Burden Statement: The annual public reporting and recordkeeping burden
for this collection of information is estimated to be 35.71 hours for
Form R and 21.96 hours for a Form A.  Burden means the total time,
effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a Federal
agency. This includes the time needed to review instructions; develop,
acquire, install, and utilize technology and systems for the purposes of
collecting/validating/verifying information, processing and maintaining
information, and disclosing and providing information; adjust existing
ways to comply with any previously applicable instructions and
requirements that have subsequently changed; train personnel to respond
to a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.

	The ICR Supporting Statement provides a detailed explanation of the
Agency’s estimate for TRI program burden, including Form R/A burden,
which is only briefly summarized here:

Estimated total number of respondents (i.e., facilities):  20,871

Frequency of response:  annual

Estimated total average number of responses:  73,727

Estimated total average number of responses for each respondent:  3.53

Estimated total annual burden hours:  3,515,751hours

Estimated total annual costs:  $174,451,565

What Changes are included in this ICR?

    	OMB approved the ICR for Form R and the ICR for the Form A
Certification Statement on March 2, 2008, with original expiration dates
of March 31, 2011.  On February 17, 2010, OMB approved an extension of
the expiration dates for both forms to July 31, 2011.  The OMB approved
burden numbers on March 2, 2008, where 3,217,280 hours for Form R and
515,901 hours for Form A, totaling 3,733,181 hours.

	Several changes in the burden estimates have been approved by OMB since
the OMB approvals of the ICRs on March 2, 2008.  On March 20, 2009, OMB
approved the merging of the ICR for TRI detailed reporting on dioxin and
dioxin-like compounds (OMB 2025-007, ICR 2086.02), into the TRI Form R
ICR (currently OMB Control Number 2025-0009), increasing burden by 899
hours.  Then on March 27, 2009, OMB approved changes in the number of
responses and the burden hours for Form R and Form A to reflect the
passage of Section 425 of the Omnibus Appropriations Act of 2009, which
rescinded the December 2006 Toxics Release Inventory Burden Reduction
Rule.  As a result, the OMB-approved numbers for Form R were increased
by 140,565 hours and for Form A burden were decreased by 318,418
yielding a net increase of 458,983 hours. Most recently, on November 26,
2010, the Addition of National Toxicology Program Carcinogens rule was
published in the Federal Register.  This rule is estimated to increase
the number of reporting facilities by 74 and the number of Form Rs
submitted by 186 with an associated burden increase of 6,641hours.

	Meanwhile, over the past several years, there has been a slight
decrease in the number of facilities reporting to TRI.  Based on the
latest data for Reporting Year 2009 plus updates to reflect changes
during the year of the ICR project—in this case, the modeled number of
chemicals and facilities estimated to report under the Addition of
National Toxicology Program Carcinogens rule, EPA now estimates the
total number of combined Form R and Form A responses to be 73,727, with
the associated total annual burden hours to be 3,515,751, and the annual
cost to be $174,451,565.  For a detailed explanation of the Agency's
estimates of the respondent reporting burden and labor costs, please
refer to the proposed TRI Form R and A Supporting Statement and the
document “Revising TRI Burden to Ratio-Based Methodology,” which are
available in the docket.

	EPA is interested in comments regarding methodology revisions
documented in the peer-reviewed technical document titled, “Revising
TRI Burden to Ratio-Based Methodology,” which is available through the
docket.  The revised methodology, Ratio-Based Burden Methodology (RBBM),
simplifies calculations, imposes internal consistency, and sharpens
transparency while retaining the components of the existing methodology
and maintaining the overall total burden estimate as a starting point.
EPA invites comments specifically regarding evidence that would quantify
the ratio of PBT/non-PBT burden for the TRI reporting community overall.

	 Additionally EPA is seeking comments on an alternate instruction for
the revision of Form R Section 8.11 in which facilities report ongoing
and newly implemented source reduction activities. The alternate
instructions would limit the scope of “ongoing source reduction
activities” to those implemented in the previous five years.

	EPA is proposing to make several changes to the TRI reporting forms and
associated instructions, but these changes are estimated to have a
negligible effect on form unit burden. The proposed changes, which are
outlined below, are designed to help enhance the overall utility of the
data collected under the TRI Program.

Remove the NA box from the Parent Company field (Part I: Sec. 5,.5.1)
Rationale: The NA box is currently used to indicate a foreign parent
company.  Removing this box and requiring facilities to report the
highest level U.S. parent company will facilitate analysis of the TRI
data at the parent company level.

	Disaggregate the “Total Transfers” field and add fields to identify
chemical discharge quantities to specific publicly owned treatment works
(POTWs) (Part II: Sec 6.1).  Rationale:   The current form collects a
single “Total Transfer” quantity for transfers to all POTWs.
Providing separate fields for the transfer quantity to each POTW will
facilitate analysis of the releases to specific watersheds.

	Section 8 enhancements, including:

Change instructional statement on form to include “newly implemented
and/or ongoing” source reduction activities (Part II: Sec. 8.10).

Add an N/A box to match associated text revisions (Part II: Sec. 8.10).

Add a field to allow separate reporting for both new and ongoing source
reduction activities (Part II: Sec. 8.10, 8.10.1-4).

Remove the “Yes” box and enlarge the text section for the question
on optional pollution prevention information (Part II: Section 8.11).

Rationale:  The current form requests information on “any source
reduction activities for this chemical during the reporting year;” but
the Reporting Forms and Instructions request information on “newly
implemented” source reduction activities.  These form changes will
remove this difference, allow facilities to distinguish between new and
ongoing source reduction activities, and provide additional optional
information on source reduction, recycling, or pollution control
activities on the form itself (in box 8.11).

	Add a new question to capture miscellaneous and optional information
regarding the submission (Part II: Sec. 9., 9.1). Rationale:  This new
text box will allow facilities to provide optional, miscellaneous
information that may be helpful to EPA and/or the public in using or
interpreting their data (e.g., facility closures, explanations for
changes in release quantities, etc.).

	Add NA boxes to Part II, Sections 5.3, 6.1, and 6.2.  Rationale:
Adding NA boxes to these sections will make the formatting of Form R and
Form R Schedule 1 more consistent.

What Is the Next Step in the Process for These ICRs?

    	EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12.  At that time, EPA will
issue another Federal Register notice for the ICR pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity  to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
individual listed under FOR FURTHER INFORMATION CONTACT.

Dated:  _______________________________

_____________________________________

Robin Gonzalez

Acting Director, Office of Information Analysis and Access

Office of Environmental Information.

[FR Doc.]

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[Federal Register: May 14, 2008 (Volume 73, Number 94)]
[Notices]
[Page 27820-27821]
[DOCID:fr14my08-56]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2002-0058; FRL-8566-2]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Information Collection Effort for
Facilities With Combustion Units, EPA ICR Number 2286.01, OMB Control
No. 2060-New

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request for a new
collection. The ICR, which is abstracted below, describes the nature of
the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before June 13, 2008.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2002-0058, to (1) EPA online using www.regulations.gov (our preferred
method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Air and Radiation Docket and
Information Center, Mailcode: 6102T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Jim Eddinger, Energy Strategies Group,
Sector Policies and Program Division, (D243-01), Environmental
Protection Agency, Research Triangle Park, North Carolina 27711;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On December 7, 2007 (72 FR 69213), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received 11 comments during the
comment period, which are addressed in the ICR. Any additional comments
on this ICR should be submitted to EPA and OMB within 30 days of this
notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2002-0058, which is available for online viewing at
www.regulations.gov, or in person viewing at the Air and Radiation
Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Reading Room is 202-566-
1744, and the telephone number for the Air and Radiation Docket is 202-
566-1742.
    Use EPA's electronic docket and comment system at
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at www.regulations.gov as EPA receives
them and without change, unless the comment contains copyrighted
material, Confidential Business Information (CBI), or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to www.regulations.gov.
    Title: Information Collection Effort for Facilities with Combustion
Units.
    ICR numbers: EPA ICR No. 2286.01, OMB Control No. 2060-New.

    ICR Status: This ICR is for a new information collection activity.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: This information collection will be conducted by EPA's
Office of Air and Radiation (OAR) to assist the Administrator of EPA,
as required by sections 112(d) and 129 of the Clean Air Act (CAA), in
determining the current population of affected combustion units and to
develop emission standards for these source categories.
    There will be two components to the information collection. To
obtain the information necessary to identify and categorize all boilers
and process heaters potentially affected by the revised standards, the
first component of this ICR will solicit information from all
potentially affected units in the format of an electronic survey under
authority of section 114 of the CAA. The survey will be submitted to
all facilities that either submitted an initial notification for the
vacated standard (40 CFR Part 63, subpart DDDDD, which was vacated by
the Courts on June 8, 2007), or if initial notification data is not
available, it will be sent to all facilities identified by States as
being subject to the vacated standard, or facilities that are
classified as a major source in their Title V permit that have a boiler
or process heater listed in their permit. The survey will also be sent
to units covered by the 2000 emissions standards for commercial and
industrial solid waste incineration units (40 CFR Part 60 Subpart CCCC)
(2000 CISWI standard) and to facilities that have incineration units
that were listed as exempt under the 2000 CISWI standard. A facility
will complete the survey for all combustion units located at the
facility. If a facility receiving the survey also has an incinerator at
the same source, they will be required to complete a separate survey
section to classify their incinerator design, operations, air pollution
control, emissions, and fuel.
    The second component will consist of requiring, if deemed
necessary, again under the authority of section 114 of the CAA, the
owners/operators of up to a total of 350 combustion units to conduct
emission testing for hazardous air pollutants (HAP) and HAP surrogates.
The Agency will analyze the results of the survey to determine if
sufficient data exist to develop emission standards under sections
112(d) and 129 of the CAA for all subcategories of fuel and combustor
types. If data are not sufficient, then the Agency will design a
statistical sample to select pools of candidates to conduct emission
testing. The Agency will submit a list of candidates within each
category to stakeholders for their review and comment. The Agency will
make a random selection of test sites, within each category, after
taking into account stakeholders comments. The testing results will be
required to be submitted to the Agency.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 24
hours per response for the survey and 85 hours per response for the
stack testing. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Respondents affected by this action
may be owners/operators of industrial, commercial, and institutional
boilers and process heaters as defined under the vacated boiler and
process heater NESHAP.
    Estimated Number of Respondents: 3,396.
    Frequency of Response: One time.
    Estimated Total Annual Hour Burden: 37,328.
    Estimated Total Annual Cost: $13,118,852. This includes estimated
O&M costs of $1,133 for the electronic survey component and $10,507,117
for the stack testing component. There are no capital or start-up
costs.
    Changes in the Estimates: Because this is a new ICR, there is no
burden currently identified in the OMB Inventory of Approved ICR
Burdens.

    Dated: May 8, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
[FR Doc. E8-10827 Filed 5-13-08; 8:45 am]

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