Document ID: FDA-2018-D-4417-0014
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pharmaceutical Voluntary Consensus Standard
Recognition
Posted Date: 2022-07-27T04:00Z

[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45114-45115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16063]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Pharmaceutical 
Voluntary Consensus Standard Recognition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
August 26, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The title of this 
information collection is ``Pharmaceutical Voluntary Consensus Standard 
Recognition.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-45, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

[[Page 45115]]

Pharmaceutical Voluntary Consensus Standard Recognition

OMB Control Number 0910--NEW

    This information collection helps support implementation of FDA's 
Center for Drug Evaluation and Research's (CDER) Program for the 
Recognition of Voluntary Consensus Standards Related to Pharmaceutical 
Quality. 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. We have developed Agency 
guidance to communicate procedures respondents can follow to submit 
requests for recognition of a voluntary consensus standard, as well as 
procedures CDER will follow when a request is received. The draft 
guidance entitled, ``CDER's Program for the Recognition of Voluntary 
Consensus Standards Related to Pharmaceutical Quality'' (February 
2019), outlines justifications for why a standard may be recognized 
wholly, partly, or not at all. (The draft guidance is available on our 
website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cders-program-recognition-voluntary-consensus-standards-related-pharmaceutical-quality.) \1\ The guidance also 
communicates that interested parties may request recognition of a 
standard, allowing CDER to:
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    \1\ When final, this guidance will represent FDA's current 
thinking on this topic.
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     receive a candidate consensus standard, with relevant 
information (e.g., the scope of the standard and the purpose), from 
internal or external parties for informal recognition;
     determine whether to informally recognize a standard in 
whole or in part following an internal scientific evaluation; and
     list the informally recognized standards in a publicly 
searchable database on FDA's website, accompanied by an information 
sheet describing the scope and the extent of informal recognition of 
that standard and other relevant information.
    In the Federal Register of February 14, 2019 (84 FR 4076), FDA 
published a 60-day notice announcing the availability of the draft 
guidance and invited comment on the proposed collection of information. 
No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1--Estimated Annual Reporting Burden
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                                                       Number of                      Average  burden                                         Total
        Guidance activity             Number of      responses per     Total annual    per  response     Total burden     Hourly wage       respondent
                                     respondents       respondent       responses         (hours)           hours             rate            costs
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Submission of request for                       9                1                9                1                9           $87.12          $784.08
 recognition of a voluntary
 consensus standard (page 2, page
 5, section B.1).................
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    Based on our experience with similar programs, we assume nine 
respondents will each submit one request for standard recognition 
annually, and that it will require 1 hour to prepare. We also assume 
industry wage rates of $87.12, for a total cost of $784.08 annually.

    Dated: July 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16063 Filed 7-26-22; 8:45 am]
BILLING CODE 4164-01-P