Notice2022-16063
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pharmaceutical Voluntary Consensus Standard Recognition
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 143 (Wednesday, July 27, 2022)</title>
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[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45114-45115]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#cc9c9e8d9fb8adaaaa8caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="7c2c2e3d2f081d1a1a3c1a181d5214140f521b130a">[email protected]</span></a>.
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: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cders-program-recognition-voluntary-consensus-standards-related-pharmaceutical-quality">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cders-program-recognition-voluntary-consensus-standards-related-pharmaceutical-quality</a>.) \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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<bullet> 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;
<bullet> determine whether to informally recognize a standard in
whole or in part following an internal scientific evaluation; and
<bullet> 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
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