
[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Proposed Rules]
[Pages 7609-7610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02731]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 106

[Docket No. FDA-2014-D-0033]


Draft Guidance for Industry: Demonstration of the Quality Factor 
Requirements for ``Eligible'' Infant Formulas; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance entitled ``Guidance for Industry: 
Demonstration of the Quality Factor Requirements for `Eligible' Infant 
Formulas.'' The draft guidance, when finalized, will describe our 
current thinking on the quality factor requirements for eligible infant 
formulas, the record requirements for eligible infant formulas, and the 
submission of citizen petitions for eligible infant formulas.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on this draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
March 27, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Nutrition, Labeling, and Dietary Supplements, 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access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 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 a draft guidance for industry 
entitled ``Guidance for Industry: Demonstration of the Quality Factor 
Requirements Under 21 CFR 106.96(i) for `Eligible' Infant Formulas.'' 
This draft guidance is being issued consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent our current thinking on this 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 alternate approach may be used if 
such approach satisfies the requirements of the applicable statutes and 
regulations.
    The draft guidance is intended to address questions regarding new 
requirements for eligible infant formulas in Sec.  106.96(i). An 
interim final rule amending part 106, and establishing the requirements 
under Sec.  106.96(i), is published elsewhere in this issue of the 
Federal Register.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to proposed collections of information 
described in FDA's interim final rule on current good manufacturing 
practices for infant formula published elsewhere in this issue of the 
Federal Register, which this draft guidance is intended to interpret. 
The proposed collections of information in the interim final rule are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). As 
required by the PRA, FDA has provided a description of these provisions 
with estimates of the annual reporting, recordkeeping, and third-party 
disclosure burden in section IV of the Regulatory Impact Analysis for 
the interim final rule, entitled ``Paperwork Reduction Act of 1995'' 
(Ref. 92 to the interim final rule) and has submitted them for OMB 
approval.

III. Comments

    Interested persons may submit either electronic comments regarding 
the guidance 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

[[Page 7610]]

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. 2014-02731 Filed 2-6-14; 8:45 am]
BILLING CODE 4160-01-P


