[Federal Register Volume 85, Number 182 (Friday, September 18, 2020)]
[Notices]
[Pages 58370-58372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the

[[Page 58371]]

Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a survey of drug product manufacturing, 
processing, and packing facilities.

DATES: Submit either electronic or written comments on the collection 
of information by November 17, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 17, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 17, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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-2020-N-1657 for ``Survey of Drug Product Manufacturing, Processing 
and Packing Facilities.'' Received comments, those filed in a timely 
manner (see ADDRESSES), 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 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.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of before submitting the 
collection to OMB for approval. To comply with this requirement, FDA is 
publishing notice of the proposed collection of information set forth 
in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (FDASIA) 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

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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.
    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: September 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20619 Filed 9-17-20; 8:45 am]
BILLING CODE 4164-01-P


