Guidance for Industry on What You Need To Know About Establishment, Maintenance, and Availability of Records-Small Entity Compliance Guide; Availability, 18867-18868 [2014-07548]

Download as PDF Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Proposed Rules 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:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either 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: April 1, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–07551 Filed 4–3–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration emcdonald on DSK67QTVN1PROD with PROPOSALS 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. VerDate Mar<15>2010 16:47 Apr 03, 2014 Jkt 232001 ACTION: Notification. 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: SUMMARY: 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 PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 18867 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; E:\FR\FM\04APP1.SGM 04APP1 18868 Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Proposed Rules 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. emcdonald on DSK67QTVN1PROD with PROPOSALS 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. VerDate Mar<15>2010 16:47 Apr 03, 2014 Jkt 232001 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] BILLING CODE 4160–01–P during the Regional Office normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays. Please see the direct final rule which is located in the Rules section of this Federal Register for detailed instructions on how to submit comments. FOR FURTHER INFORMATION CONTACT: ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R05–OAR–2013–0646; FRL–9908–71– Region 5] Approval and Promulgation of Air Quality Implementation Plans; Michigan; PSD Rules for PM2.5 Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to approve revisions to Michigan’s Prevention of Significant Deterioration Program rules and definitions, including revisions to Parts 1 and 18 of Michigan’s Air Pollution Control Rules into Michigan’s State Implementation Plan (SIP). The revised rules address the Federal requirements for significant emission levels, and definitions for fine particulate matter. The Michigan Department of Environmental Quality submitted these revisions to EPA on August 9, 2013, and September 19, 2013. SUMMARY: Comments must be received on or before May 5, 2014. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–R05– OAR–2013–0646, by one of the following methods: 1. www.regulations.gov: Follow the on-line instructions for submitting comments. 2. Email: damico.genevieve@epa.gov. 3. Fax: (312) 886–0968. 4. Mail: Genevieve Damico, Chief, Air Permits Section, Air Programs Branch (AR–18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. Hand Delivery: Genevieve Damico, Chief, Air Permits Section, Air Programs Branch (AR–18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only accepted DATES: PO 00000 Frm 00023 Fmt 4702 Sfmt 9990 Constantine Blathras, Environmental Engineer, Air Permits Sections, Air Programs Branch (AR–18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886–0671, Blathras.constantine@epa.gov. In the Rules section of this Federal Register, EPA is approving the State’s SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, we will withdraw the direct final rule and will address all public comments in a subsequent final rule based on this proposed action. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule which may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules section of this Federal Register. SUPPLEMENTARY INFORMATION: Dated: March 17, 2014. Susan Hedman, Regional Administrator, Region 5. [FR Doc. 2014–06827 Filed 4–3–14; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\04APP1.SGM 04APP1

Agencies

[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.

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

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]
BILLING CODE 4160-01-P