[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Proposed Rules]
[Pages 18867-18868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07548]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2013-N-1421]


Guidance for Industry on What You Need To Know About 
Establishment, Maintenance, and Availability of Records--Small Entity 
Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``What You Need To 
Know About Establishment, Maintenance, and Availability of Records--
Small Entity Compliance Guide'' (SECG), which updates an earlier 
guidance of the same title. Previously, this guidance restated the 
legal requirements of FDA's maintenance and establishment of records 
regulation and served as that regulation's SECG. Because the FDA Food 
Safety Modernization Act (FSMA) amended FDA's maintenance and 
establishment of records regulation, FDA issued an interim final rule 
(IFR) amending certain regulations to be consistent with the changes. 
Accordingly, FDA is revising this guidance to help any entity comply 
with FDA's maintenance and establishment of records requirements, 
including the amendments to these requirements made by the IFR as 
finalized. This guidance continues to serve as FDA's SECG.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Outreach and Information Center, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration (HFS-009), 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. 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: William A. Correll, Jr., Office of 
Compliance, Center for Food Safety and Applied Nutrition (HFS-009), 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-1611.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``What You Need To Know About Establishment, Maintenance, and 
Availability of Records--Small Entity Compliance Guide (SECG).'' This 
guidance is being issued consistent with our good guidance practices 
regulation (21 CFR 10.115(c)(2)). The guidance represents our current 
thinking on the establishment, maintenance, and availability of 
records. 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.
    FSMA (Pub. L. 111-353), among other things, amended FDA's records 
access under section 414(a) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act). In the Federal Register of February 23, 2012 (77 FR 10658), 
FDA issued an IFR that amended certain requirements on the availability 
of records in the regulation on the establishment and maintenance of 
records in 21 CFR Part 1, Subpart J to be consistent with amendments to 
the FD&C Act made by FSMA. This interim final rule was effective March 
1, 2012.
    Previously, this guidance restated the legal requirements of FDA's 
establishment and maintenance of records regulation at 21 CFR part 1, 
Subpart J, implementing section 414 of the FD&C Act, as added by the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (Pub. L. 107-188). This guidance also served as FDA's SECG for 
21 CFR Part 1, Subpart J in accordance with section 212 of the Small 
Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). Because 
section 101 of FSMA amended section 414(a) of the FD&C Act, FDA issued 
an IFR amending certain requirements on the availability of records in 
21 CFR Part 1, Subpart J. Elsewhere in this issue of the Federal 
Register, we are issuing a final rule adopting the IFR without changes. 
The final rule is effective upon publication. Accordingly, FDA is 
updating this SECG to help any entity comply with the requirements in 
21 CFR part 1, Subpart J, including the amendments to 21 CFR Part 1, 
Subpart J made by the IFR and adopted as final. This guidance continues 
to serve as FDA's SECG for 21 CFR part 1, Subpart J.
    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires Agencies 
to determine whether a final rule will have a significant impact on 
small entities when an Agency issues a final rule ``after being 
required . . . to publish a general notice of proposed rulemaking.'' 
Although FDA is not required to perform a regulatory flexibility 
analysis because, in accordance with 5 U.S.C. 553(b)(3)(B) and 21 CFR 
10.40(e)(1), the Agency found for good cause that use of prior notice 
and comment procedures were contrary to the public interest;

[[Page 18868]]

FDA has nonetheless examined the economic implications of the final 
rule in accordance with the Regulatory Flexibility Act and determined 
that the final rule will not have a significant economic impact on a 
substantial number of small entities. Similarly, because FDA is not 
required to perform a final regulatory flexibility analysis under 5 
U.S.C 605(b) for the final rule, FDA is not required to issue an SECG 
to comply with section 212 of the Small Business Regulatory Enforcement 
Fairness Act (Pub. L. 104-121); nevertheless, FDA has updated this SECG 
to state in plain language the requirements of 21 CFR part 1, Subpart 
J, as amended by the final rule.

II. Paperwork Reduction Act of 1995

    This guidance refers to information collection provisions 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). Except for the provision 
regarding access to records, the collections of information in 21 CFR 
part 1, Subpart J, have been approved under OMB control number 0910-
0560. With regard to access to records, we conclude that these 
information collection provisions are exempt from OMB review under 44 
U.S.C. 3518(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) as collections of 
information obtained during the conduct of a civil action to which the 
United States or any official or Agency thereof is a party, or during 
the conduct of an administrative action, investigation, or audit 
involving an Agency against specific individuals or entities. The 
regulations in 5 CFR 1320.3(c) provide that the exception in 5 CFR 
1320.4(a)(2) applies during the entire course of the investigation, 
audit or action, but only after a case file or equivalent is opened 
with respect to a particular party. Such a case file would be opened as 
part of the request to access records.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document 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://regulations.gov.

IV. Electronic Access

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

    Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07548 Filed 4-3-14; 8:45 am]
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