
[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Rules and Regulations]
[Pages 33056-33057]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 106

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


Guidance for Industry: Demonstration of the Quality Factor 
Requirements for ``Eligible'' Infant Formulas; 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 a final guidance which describes 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: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the 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 guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov.

[[Page 33057]]

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, 240-402-1451.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Guidance for Industry: Demonstration of the Quality Factor 
Requirements Under 21 CFR 106.96(i) for `Eligible' Infant Formulas.'' 
This guidance is being issued consistent with our good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 guidance is intended to address questions regarding new 
requirements for eligible infant formulas in 21 CFR 106.96(i). A final 
rule amending part 106, and establishing the requirements under Sec.  
106.96(i), is published elsewhere in this issue of the Federal 
Register.
    In the Federal Register of February 10, 2014 (79 FR 7609), we made 
available a draft guidance entitled ``Draft Guidance for Industry: 
Demonstration of the Quality Factor Requirements for `Eligible' Infant 
Formulas'' and gave interested parties an opportunity to submit 
comments by March 27, 2014, for us to consider before beginning work on 
the final version of the guidance. We received no comments on the draft 
guidance but have modified the final guidance where appropriate to 
correspond to requirements set forth in the final rule, ``Current Good 
Manufacturing Practices, Quality Control Procedures, Quality Factors, 
Notification Requirements, and Records and Reports, for Infant 
Formula,'' published elsewhere in this issue of the Federal Register. 
For example, because the final rule revised the definition of an 
``eligible infant formula'' from what was originally published in an 
interim final rule on February 10, 2014 (79 FR 7934), we revised the 
guidance to reflect that change. In addition, we revised the guidance 
to provide more detailed recommendations if a manufacturer includes 
proprietary information in its citizen petition submitted in accordance 
with Sec.  106.96(i)(3). Furthermore, we made other edits so that the 
language in the guidance corresponds more closely to that used in the 
final rule. The guidance announced in this document finalizes the draft 
guidance dated February 2014.

II. Paperwork Reduction Act of 1995

    This guidance refers to existing regulations in part 10 (21 CFR 
part 10) as well as the final rule, ``Current Good Manufacturing 
Practices, Quality Control Procedures, Quality Factors, Notification 
Requirements, and Records and Reports, for Infant Formula,'' published 
elsewhere in this issue of the Federal Register, which amends parts 106 
and 107 (21 CFR parts 106 and 107). The collection of information in 
part 10 has been approved under OMB control number 0910-0183. The 
collections of information in parts 106 and 107 have been approved 
under OMB control number 0910-0256. These collections of information 
amended by the final rule 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 Information Collection Request for the final 
rule is currently under review.

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 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 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: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13386 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P


