Document ID: FDA-2020-N-1657-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey of Drug
Product Manufacturing, Processing,
and Packing Facilities
Posted Date: 2021-01-15T05:00Z

[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4098-4099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00838]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1657]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Survey of Drug 
Product Manufacturing, Processing, and Packing Facilities

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 (including recommendations) on the 
collection of information by February 16, 2021.

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 
Comment'' or by using the search function. The title of this 
information collection is ``Survey of Drug Product Manufacturing, 
Processing, and Packing Facilities.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

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 4099]]

Survey of Drug Product Manufacturing, Processing, and Packing 
Facilities--21 CFR parts 210 and 211

OMB Control Number 0910-NEW

    FDA has the responsibility to regulate the safety, as well as the 
efficacy and quality, of drugs in the United States. Under the Food and 
Drug Administration Safety and Innovation Act, enacted in 2012, the 
term current good manufacturing practice (CGMP) includes the 
implementation of oversight and controls over the manufacturing, 
processing, and packing of drugs to ensure quality, including managing 
the risk of, and establishing the safety of, raw materials used in the 
manufacture of drugs. The safety and availability of drugs can be 
affected by raw material suppliers, the material supply chain, and the 
facility's controls over raw material quality. Risk management enables 
manufacturers to make proper choices and ensure the continued 
suitability of these materials and supply chains. The Agency needs to 
better understand how manufacturers, processors, and packers of drug 
products approach managing risks related to components, containers, and 
closures as well as the supply and distribution chains between the 
producers of raw materials and drug product manufacturers, processors, 
and packers. Such information will allow FDA to examine the potential 
economic impact of changes to regulations that govern the 
manufacturing, processing, and packing of drugs.
    In the Federal Register of September 18, 2020 (85 FR 58370), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited 
and therefore will not be discussed in this document.
    This is a one-time information collection, the primary purpose of 
which is to collect industry-wide data on how facilities that 
manufacture, process, and pack drug products for use in humans and/or 
animals ensure the quality of their operations, including their current 
risk management approaches and practices for ensuring the quality and 
suitability of the drug components, containers, and closures that they 
use. FDA intends to use this information to inform its economic 
analyses of potential updates to CGMPs for human and animal drug 
product manufacturing, processing, and packing facilities under 21 CFR 
parts 210 and 211. Survey respondents will be contacted by email or, if 
necessary, by regular mail. Respondents will be able to take the survey 
online or, if requested, they can return a hard copy by mail. FDA 
estimates the maximum burden of this collection of information as 
follows:

                        Table 1.--Estimated Burden Hours for One-Time Data Collection\1\
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                                                  Number of
 Type of respondent/facility      Number of     responses per   Total annual     Average burden     Total hours
                                 respondents     respondent       responses       per response
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Group 1: Facilities in United             394               1             394  1.1..............             433
 States engaged in drug
 manufacturing (in addition
 to other possible
 activities).
Group 2: Facilities in United             333               1             333  0.75.............             250
 States not engaged in                                                         (45 minutes).....
 manufacturing but engaged in
 other forms of drug
 processing or packing (e.g.,
 labeling, repacking, etc.).
Group 3: Facilities outside               407               1             407  2.20.............             895
 United States engaged in
 drug manufacturing (in
 addition to other possible
 activities).
Group 4: Facilities outside               261               1             261  1.5..............             392
 United States not engaged in
 manufacturing but engaged in
 other forms of drug
 processing or packing (e.g.,
 labeling, repacking, etc.).
Total........................           1,395  ..............           1,395  .................           1,970
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Burden hours are based on pretests of the survey and interviews 
with industry representatives and reflect the time required by each 
type of respondent to read the survey invitation and instructions and 
complete the survey questions. The total estimated one-time burden 
hours are 1,970.

    Dated: January 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00838 Filed 1-14-21; 8:45 am]
BILLING CODE 4164-01-P