[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Notices]
[Page 19513-19514]
[DOCID:fr10ap08-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0165] (formerly Docket No. 2006D-0413)

Guidance for Industry on Blue Bird Medicated Feed Labels;
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (181) entitled ``Blue
Bird Medicated Feed Labels.'' This guidance provides new animal drug
application (NADA) sponsors with the Center for Veterinary Medicine's
current thinking on what constitutes recommended content and format of
representative labels for new animal drugs intended for use in the
manufacture of medicated feeds.

DATES:  Submit written or electronic comments on agency guidances at
any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your requests.
    Submit written comments on this guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for
Veterinary Medicine (HFV-220), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 30, 2006 (71 FR 63328), FDA
published a notice of availability for a draft guidance entitled
``Draft Guidance for Industry: Blue Bird Medicated Feed Labels'' giving
interested persons until January 16, 2007, to comment on the draft
guidance. FDA received several comments on the draft guidance and those
comments were considered as the guidance was finalized. The guidance
announced in this notice finalizes the draft guidance dated October 30,
2006.
    This Level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This guidance represents
the agency's current thinking on the topic. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This 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
collections of information in 21 CFR 514.1(b)(3) have been approved
under OMB control number 0910-0032.

III. Comments

    Submit written requests for single copies of the guidance to the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
requests.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments should be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: April 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7500 Filed 4-9-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46496-46497]
[FR Doc No: 2018-19909]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1857]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Food for Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October
15, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0789.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals--21 CFR Part 507

OMB Control Number 0910-0789--Extension

    The information collection supports FDA regulations. As amended by
the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the
Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the Agency to
better protect the public health by helping to ensure the safety and
security of the food supply. It enables FDA to focus more on preventing
food safety problems rather than relying primarily on reacting to
problems after they occur. FSMA recognizes the important role industry
plays in ensuring the safety of the food supply, including the adoption
of modern systems of preventive controls in food production.
Specifically, section 418 (21 U.S.C. 350g) of the FD&C Act sets forth
requirements for hazard analysis and risk-based preventive controls for
facilities that produce food for animals. To implement these
provisions, regulations were codified under 21 CFR part 507--Current
Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive
Controls For Food For Animals. The regulations establish requirements
for a written food safety plan; hazard analysis preventive controls;
monitoring; corrective actions and corrections; verification; supply-
chain program; recall plan; and associated records and became effective
November 16, 2015. Currently, we continue to evaluate burden associated
with the information collection requirements however, for purposes of
extending the information collection we retain the currently approved
figures as shown in the following tables.
    In the Federal Register of May 24, 2018 (83 FR 24124), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received three comments, however none
pertained to the information collection or underlying regulations.
    We estimate our burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                              Number of
                                 Number of    responses      Total
   21 CFR section; activity     respondents      per         annual     Average burden per response  Total hours
                                              respondent   responses
----------------------------------------------------------------------------------------------------------------
507.7 exemption: submit               1,120          0.5          560  0.5 (30 minutes)............          280
 attestation of preventive
 controls or compliance with
 State and local laws (non-
 federal).

507.67, 507.69, and 507.71;               1            1            1  4...........................            4
 submission of an appeal,
 including submission of a
 request for an informal
 hearing.
507.85(b); requests for                   1            1            1  2...........................            2
 reinstatement of exemption.
                               ---------------------------------------------------------------------------------
    Total.....................  ...........  ...........  ...........  ............................          286
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                Number of      Total
   21 CFR section; activity      Number of     records per     annual        Average burden per      Total hours
                               recordkeepers  recordkeeper    records           recordkeeping
----------------------------------------------------------------------------------------------------------------
                                          Subpart A--General Provisions
----------------------------------------------------------------------------------------------------------------
507.7(e); records attesting           1,120            0.5          560  0.1 (6 minutes)...........           56
 that the facility is a
 ``qualified'' facility.
507.4(d); documentation of            7,469           0.75        5,579  0.05 (3 minutes)..........          279
 animal food safety and
 hygiene training.
----------------------------------------------------------------------------------------------------------------
                          Subpart C--Hazard Analysis and Risk-Based Preventive Controls
----------------------------------------------------------------------------------------------------------------
507.31 through 507.55; food           7,469            519    3,876,411  0.1 (6 minutes)...........      387,641
 safety plan--including
 hazard analysis, preventive
 controls, monitoring,
 corrective actions,
 verification, validation
 reanalysis, modifications,
 and implementation records.
----------------------------------------------------------------------------------------------------------------
                                         Subpart E--Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
507.105 through 507.175;              7,469            519    3,876,411  0.1 (6 minutes)...........      387,641
 written supply-chain
 program--including records
 documenting program.
----------------------------------------------------------------------------------------------------------------
                                   Subpart F--Requirements Applying to Records
----------------------------------------------------------------------------------------------------------------
507.200 through 507.215;              7,469            519    3,876,411  0.1 (6 minutes)...........      387,641
 general requirements,
 additional requirements
 applying to food safety
 plan, requirements for
 record retention, use of
 existing records, and
 special requirements
 applicable to written
 assurance.
                              ----------------------------------------------------------------------------------
    Totals...................  .............  ............   11,635,372  ..........................    1,163,258
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                              Number of
                                 Number of   disclosures     Total          Average burden per
   21 CFR section; activity     respondents      per         annual             disclosure           Total hours
                                              respondent  disclosures
----------------------------------------------------------------------------------------------------------------
507.27(b); labeling for the             330           10        3,300  0.25 (15 minutes)...........          825
 animal food product contains
 the specific information and
 instructions needed so the
 food can be safely used for
 the intended animal species.
507.7(e)(1); change labels on         1,526            4        6,104  1...........................        6,104
 products with labels.
507.7(e)(2); change address on        1,329            1        1,329  1...........................        1,329
 labeling (sales documents)
 for qualified facilities.
507.25(a)(2); animal food,              330          312      102,960  0.01 (36 seconds)...........        1,030
 including raw materials,
 other ingredients, and
 rework, is accurately
 identified.
507.28(b); holding and               40,798            2       81,596  0.25 (15 minutes)...........       20,399
 distribution of human food
 byproducts for use as animal
 food.
                               ---------------------------------------------------------------------------------
    Total.....................  ...........  ...........  ...........  ............................       29,687
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    As previously stated, we retain the currently approved burden
estimate for the information collection. These figures are based on our
regulatory impact analysis in support of the final rule on Preventive
Controls for Food for Animals, which published in the Federal Register
of September 17, 2015 (80 FR 56170). Using Agency data, we estimated
the number of animal food facilities that we believe are subject to the
regulations. We base our estimate of the time necessary for the
individual reporting, recordkeeping, and third-party disclosure
activities on our experience with similar information collections.

    Dated: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19909 Filed 9-12-18; 8:45 am]
 BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2565 PLYMOUTH ROAD

ANN ARBOR, MICHIGAN 48105-2498

OFFICE OF

AIR AND RADIATION

MEMORANDUM

SUBJECT:	Heavy-Duty Hybrid Onboard Diagnostics

FROM:		Amy Kopin

TO:		The Docket

DATE:		July 21, 2011

	On March 28th, 2011 we held a conference call with Lisa A. Stegink of
the Engine Manufacturers Association (EMA)to discuss concerns raised by
members of EMA regarding heavy-duty onboard diagnostic (OBD)
requirements and timing.  EMA members raised concerns during the comment
period for the heavy-duty greenhouse gas notice of proposed rulemaking
that heavy-duty hybrid applications may not be able to meet the 2013
heavy-duty OBD regulations that were published in the 2009 OBD Final
Rulemaking. ,  Specifically, their comments include a request for a
delay of the application of HD OBD requirements for hybrid applications
until 2020.   Attendees from the EPA included Cleophas Jackson, Anthony
Neam, and Amy Kopin.

 U.S. EPA, NHTSA, and DOT, “Greenhouse Gas Emission Standards and Fuel
Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles,”
republished December 29, 2010.  Available here:
http://origin.www.gpo.gov/fdsys/pkg/FR-2010-12-29/html/2010-32726.htm

 U.S. EPA, “Control of Air Pollution from New Motor Vehicles and New
Motor Vehicles Engines; Final Rule Regulations Requiring Onboard
Diagnostic Systems on 2010 and Later Heavy-Duty Engines Used in Highway
Applications Over 14,000 Pounds; Revisions to Onboard Diagnostic
Requirements for Diesel Highway Heavy-Duty Vehicles Under 14,000
Pounds,” published February 24, 2009.  Available here:
http://www.epa.gov/otaq/regs/im/obd/regtech/hd-obd-frm-02-24-09-notice-7
4-fr-8310.pdf


[Federal Register: March 13, 2009 (Volume 74, Number 48)]
[Notices]
[Page 10909-10911]
[DOCID:fr13mr09-50]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2008-0911, FRL-8780-9]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Notification of Regulated Waste Activity (Renewal),
EPA ICR Number 0261.16, OMB Control Number 2050-0028

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 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 June 30, 2009. 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 May 12, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2008-0911, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: RCRA Docket (2822T), U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
     Hand Delivery: 1301 Constitution Ave., NW., Room 3334,
Washington, DC 20460. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-RCRA-
2008-0911. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-
mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://
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. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Toshia King, Office of Solid Waste,
mailcode 5303W, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

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

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-RCRA-2008-0911, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the RCRA 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<PHONE_NUMBER>, and the
telephone

number for RCRA Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search,'' then key in the docket ID number
identified in this document.

What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) 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;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) 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 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:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to 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: Entities potentially affected by this action are
business or other for-profit as well as State, Local, or Tribal
governments.
    Title: Notification of Regulated Waste Activity (Renewal).
    ICR numbers: EPA ICR No. 0261.16, OMB Control No. 2050-0028.
    ICR status: This ICR is currently scheduled to expire on June 30,
2009. 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: Section 3010 of Subtitle C of RCRA, as amended, requires
any person who generates or transports regulated waste or who owns or
operates a facility for the treatment, storage, or disposal (TSD) of
regulated waste to notify EPA of their activities, including the
location and general description of activities and the regulated wastes
handled. The facility is then issued an EPA Identification number. The
facilities are required to use the Notification Form (EPA Form 8700-12)
to notify EPA of their hazardous waste activities. EPA needs this
information to determine the universe of persons who generate, handle,
and manage these regulated wastes; assign EPA Identification Numbers;
and ensure that these regulated wastes are managed in a way that
protects human health and the environment, as required by RCRA, as
amended.
    EPA enters notification information submitted by respondents into
the EPA National data base and assigns EPA Identification Numbers. EPA
uses the information primarily for tracking purposes, and secondarily
for a variety of enforcement and inspection purposes. In addition, EPA
uses this information to identify the universe of regulated waste
generators, handlers, and managers and their specific regulated waste
activities. Finally, EPA uses this information to ensure that regulated
waste is managed properly, that statutory provisions are upheld, and
that regulations are adhered to by facility owners or operators.
    Section 3007(b) of RCRA and 40 CFR part 2, subpart B, which defines
EPA's general policy on public disclosure of information, both contain
provisions for confidentiality. However, the Agency does not anticipate
that businesses will assert a claim of confidentiality covering all or
part of the Notification of Regulated Waste Activity. If such a claim
were asserted, EPA must and will treat the information in accordance
with the regulations cited above. EPA also will assure that this
information collection complies with the Privacy Act of 1974 and OMB
Circular 108.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 2
hours per response for the initial notification, and 1 hour per
response for any subsequent notifications. 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.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 55,915.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 100,307 hours.
    Estimated total annual costs: $9,690,000, includes $0 annualized
capital costs and $235,000 annualized O&M costs and $9,455,000 annual
labor costs.

What Is the Next Step in the Process for This ICR?

    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
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 technical person listed under FOR FURTHER INFORMATION
CONTACT.

    Dated: March 5, 2009.
James R. Berlow,
Acting Director, Office of Resource Conservation and Recovery.
 [FR Doc. E9-5529 Filed 3-12-09; 8:45 am]

BILLING CODE 6560-50-P