[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Notices]
[Pages 22961-22962]
[FR Doc No: 2014-09457]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0563; FRL 9909-88-OEI]

Information Request Submitted to OMB for Review and Approval;
Comment Request; National Volatile Organic Compound Emission Standards
for Consumer Products (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), National Volatile Organic
Compound Emission Standards for Consumer Products (EPA ICR No. 1764.06,
OMB Control No. 2060-0348), to the Office of Management and Budget
(OMB) for review and approval in accordance with the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of
the ICR, which is currently approved through April 30, 2014. Public
comments were previously requested via the Federal Register (79 FR
3799) on January 23, 2014, during a 60-day comment period. This notice
allows for an additional 30 days for public comment. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. 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.

DATES: Additional comments may be submitted on or before May 27, 2014.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2007-0563, to (1) EPA online using www.regulations.gov (our
preferred method), by email<EMAIL_ADDRESS>(include Docket ID
Number EPA-HQ-OAR-2007-0563 in the subject line of the message), or by
mail to: EPA Docket Center, Environmental Protection Agency, Mail Code
28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB
via email to<EMAIL_ADDRESS>Address comments to OMB Desk
Officer for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Ms. Kim Teal, Office of Air Quality
Planning and Standards, Sector Policies and Programs Division, Mail
Code D243-04, Research Triangle Park, North Carolina 27711; telephone
number<PHONE_NUMBER>; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The telephone number for the Docket Center
is<PHONE_NUMBER>. The docket can be viewed online at www.regulations.gov
or in person at the EPA Docket Center, William Jefferson Clinton
Building West, Room 3334, 1301 Constitution Ave. NW., Washington, DC
20004. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Abstract: The EPA is required under section 183(e) of the Clean Air
Act (CAA) to regulate volatile organic compound emissions from the use
of consumer and commercial products. Pursuant to CAA section 183(e)(3),
the EPA published a list of consumer and commercial products and a
schedule for their regulation (60 FR 15264). Consumer products were
included on the list, and the standards are codified at 40 CFR part 59,
subpart C. The information collection includes initial

reports and periodic recordkeeping necessary for the EPA to ensure
compliance with federal standards for volatile organic compounds in
consumer products. Responses to the collection are mandatory under 40
CFR part 59, subpart C, National Volatile Organic Compound Emission
Standards for Consumer Products. All information submitted to the EPA
for which a claim of confidentiality is made will be safeguarded
according to the agency's policies set forth in 40 CFR part 2, subpart
B, Confidentiality of Business Information.
    The ICR provides a detailed explanation of the agency's estimate,
which is only briefly summarized here:
    Form Numbers: None.
    Respondents/affected entities: Manufacturers and importers of
consumer products.
    Respondent's obligation to respond: Mandatory under 40 CFR part 59,
subpart C, ``National Volatile Organic Compound Emission Standards for
Consumer Products,'' and provide assurance that the mandates of section
183(e) of the CAA are being achieved.
    Estimated number of respondents: 732 total.
    Frequency of response: On occasion.
    Total estimated burden: 29,613 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $1,364,069 (per year), which no capital or
operation & maintenance costs.
    Changes in the Estimates: There are no changes in the total
estimated respondent burden compared with the ICR currently approved by
OMB.

    Dated: April 17, 2014.
Erin Collard,
Acting Director, Collection Strategies Division.
[FR Doc. 2014-09457 Filed 4-24-14; 8:45 am]
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[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37229-37230]
[FR Doc No: 2017-16719]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0829]

Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form
Drug Products; Revised 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 revised draft guidance for industry entitled
``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug
Products.'' The last few decades have seen an increasing demand in
various health care settings for solid oral dosage form drug products
repackaged into unit-dose containers, which hold a quantity of drug for
administration as a single dose. The increase in unit-dose repackaging
has led to questions regarding stability studies and appropriate
expiration dates for these repackaged products. This revised draft
guidance describes the conditions under which FDA does not intend to
take action regarding required stability studies for these repackaged
products and the expiration date to assign under those conditions.
Through this notice, FDA is hoping to decrease the regulatory burdens
of drug regulations on manufacturers of these products, while at the
same time ensuring patient safety. Since FDA's guidance documents do
not bind the public or FDA to any requirements, they have not been
considered to be subject to Executive Order 12866.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
revised draft guidance before it begins work on the final version of
the guidance, submit either electronic or written comments on the draft
guidance by October 10, 2017.

ADDRESSES: You may submit comments 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-2017-D-0829 for ``Expiration Dating of Unit-Dose Repackaged Solid
Oral Dosage Form Drug Products.'' 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.
    Submit written requests for single copies of the revised 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. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the revised draft guidance document.

FOR FURTHER INFORMATION CONTACT: Bill Harvey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4214, Silver Spring, MD 20993-0002, 240-
402-4180.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry

entitled ``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage
Form Drug Products.'' FDA's current good manufacturing practice (CGMP)
regulations for finished pharmaceuticals require that each drug product
bear an expiration date determined by appropriate stability testing and
that the date must be related to any storage conditions stated on the
labeling, as determined by stability studies (21 CFR 211.137(a) and
(b)). Samples used for stability testing must be in the same container-
closure system as that in which the drug product is marketed (21 CFR
211.166(a)(4)). For unit-dose repackaged products, U.S. Pharmacopeial
Convention (USP) General Chapter <1178> recommends that the expiration
date ``not exceed (1) 6 months from the date of repackaging; or (2) the
manufacturer's expiration date; or (3) 25% of the time between the date
of repackaging and the expiration date shown on the manufacturer's bulk
article container of the drug being repackaged, whichever is earlier.''
    For solid oral dosage forms repackaged in unit-dose containers, the
revised draft guidance states that FDA does not intend to take action
regarding the requirements of Sec. Sec.  211.137 and 211.166 (i.e.,
expiration dating determined by stability studies) under certain
conditions. This revised draft guidance describes these conditions.
    This draft guidance revises an earlier draft guidance for industry,
``Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy
Guide.'' Changes include the following:
     Shortens the expiration date to be used under certain
conditions for solid oral dosage forms repackaged in unit-dose
containers from 12 months to 6 months or 25 percent of the time
remaining until the expiration date on the container of the original
manufacturer's product, whichever time period is shorter.
     Provides for an expiration date exceeding 6 months if
supportive data from appropriate studies are available and other
conditions are met.
     Excludes from the scope of the guidance products
repackaged by State-licensed pharmacies, Federal facilities, and
outsourcing facilities as defined under section 503B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 353b).
     Excludes from the scope of the guidance all dosage forms
other than solid oral dosage forms.
     Provides for the use of containers meeting USP <671> Class
B standards if certain conditions are met.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
expiration dating of unit-dose repackaged solid oral dosage form drug
products. 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.
    The current Compliance Policy Guide 480.200, ``Expiration Dating of
Unit-Dose Repackaged Drugs,'' issued February 1, 1984, revised March
1995, will be withdrawn when the revised draft guidance is finalized.

II. The Paperwork Reduction Act of 1995

    This revised draft guidance refers to previously approved
collections of information that 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 parts
210 and 211 have been approved under OMB control number 0910-0139.

III. Electronic Access

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

    Dated: August 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16719 Filed 8-8-17; 8:45 am]
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