[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Notices]
[Pages 48470-48472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15916]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4417]


Center for Drug Evaluation and Research's Program for the 
Recognition of Voluntary Consensus Standards Related to Pharmaceutical 
Quality; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``CDER's 
Program for the Recognition of Voluntary Consensus Standards Related to 
Pharmaceutical Quality.'' This guidance describes a program at FDA's 
Center for Drug Evaluation and Research (CDER) to make public a 
comprehensive listing of recognized voluntary consensus standards 
related to pharmaceutical quality. This program facilitates submissions 
by external stakeholders and FDA staff proposing voluntary consensus 
standards related to pharmaceutical quality for recognition. CDER 
believes that this program will help promote innovation in 
pharmaceutical development and manufacturing and streamline the 
preparation and assessment of marketing applications for products 
regulated by CDER. This guidance

[[Page 48471]]

finalizes the draft guidance of the same title issued on February 14, 
2019.

DATES: The announcement of the guidance is published in the Federal 
Register on July 27, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-4417 for ``CDER's Program for the Recognition of Voluntary 
Consensus Standards Related to Pharmaceutical Quality.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9 
a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Colleen Thomas, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4159, Silver Spring, MD 20993-0002, 301-
796-4853.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``CDER's Program for the Recognition of Voluntary Consensus 
Standards Related to Pharmaceutical Quality.'' This guidance describes 
a program at CDER to make public a comprehensive listing of recognized 
voluntary consensus standards related to pharmaceutical quality. This 
program, established by publication of this final guidance, facilitates 
submissions by external stakeholders and FDA staff proposing voluntary 
consensus standards related to pharmaceutical quality for recognition.
    The National Technology Transfer and Advancement Act of 1995 (Pub. 
L. 104-113) and Circular A-119 by the Office of Management and Budget 
(OMB) have established Federal Government policies to improve the 
internal management of the executive branch by directing Agencies to 
use voluntary consensus standards developed or adopted by a standards-
developing organization--rather than Government-unique standards--
except where these standards are inconsistent with applicable law or 
otherwise impractical. FDA's development and use of standards have been 
integral to the execution of FDA's mission.
    This program will help promote innovation in pharmaceutical 
development and manufacturing and streamline the preparation and review 
of marketing applications for products regulated by CDER. CDER also 
believes that this program (1) allows CDER to communicate to external 
stakeholders that its relevant expert(s) have evaluated a consensus 
standard and determined if that standard is potentially useful both to 
industry and FDA staff, and (2) provides transparency to industry 
regarding CDER's thinking about a method or approach.
    This guidance finalizes the draft guidance entitled ``CDER's 
Program for the Recognition of Voluntary Consensus Standards Related to 
Pharmaceutical Quality'' issued on February 14, 2019 (84 FR 4076). FDA 
considered comments received on the draft guidance as the guidance was 
finalized. Changes from the draft to the final guidance include: 
clarification of the program's policies and procedures and the 
program's relationship to existing guidances, regulations, and policies 
under which CDER operates.

[[Page 48472]]

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``CDER's Program for the Recognition of 
Voluntary Consensus Standards Related to Pharmaceutical Quality.'' It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collection 
of information in this guidance has been approved under OMB control 
number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15916 Filed 7-26-23; 8:45 am]
BILLING CODE 4164-01-P