[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Proposed Rules]
[Page 7610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02732]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 106

[Docket No. FDA-2014-D-0044]


Draft Guidance for Industry; Exempt Infant Formula Production: 
Current Good Manufacturing Practices, Quality Control Procedures, 
Conduct of Audits, and Records and Reports; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of the draft guidance entitled ``Guidance for Industry; 
Exempt Infant Formula Production: Current Good Manufacturing Practices 
(CGMPs), Quality Control Procedures, Conduct of Audits, and Records and 
Reports.'' The draft guidance, when finalized, will describe our 
current thinking on the manufacturing of exempt infant formula in 
relation to the requirements for CGMPs, quality control procedures, 
conduct of audits, and records and reports that apply to nonexempt 
infant formulas.

DATES: Although you may comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on the 
draft guidance before we begin work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 12, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Nutrition, Labeling, and Dietary Supplements, 
Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Benson M. Silverman, Center for Food 
Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1459.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of the draft guidance entitled 
``Guidance for Industry; Exempt Infant Formula Production: Current Good 
Manufacturing Practices (CGMPs), Quality Control Procedures, Audit 
Procedures, and Records and Reports.'' Section 412(h)(1) (21 U.S.C. 
350a(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
exempts an infant formula which is represented and labeled for use by 
an infant with an inborn error of metabolism, low birth weight, or who 
otherwise has an unusual medical or dietary problem from sections 
412(a), (b), and (c) of the FD&C Act. These formulas are customarily 
referred to as ``exempt infant formulas.'' The draft guidance is 
intended to describe the significance of the regulations in 21 CFR part 
106 for production of exempt infant formulas. Amendments to part 106, 
in the form of an interim final rule, are published elsewhere in this 
issue of the Federal Register.
    We are issuing this draft guidance as Level 1 draft guidance 
consistent with our good guidance practices regulation (21 CFR 10.115). 
The draft guidance, when finalized, will represent our current thinking 
on the manufacturing of exempt infant formulas in relation to the 
requirements for CGMPs, quality control procedures, conduct of audits, 
and records and reports for nonexempt infant formulas in part 106. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternate approach may be used if 
such approach satisfies the requirements of the applicable statutes and 
regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish 
notice in the Federal Register soliciting public comment on each 
proposed collection of information before submitting the collection to 
OMB for approval. To comply with this requirement, FDA will publish a 
60-day notice on the proposed collection of information in a future 
issue of the Federal Register.

III. Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance and proposed collection of information to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use 
the FDA Web site listed in the previous sentence to find the most 
current version of the guidance.

    Dated: February 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02732 Filed 2-6-14; 8:45 am]
BILLING CODE 4160-01-P