[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51433-51435]
[FR Doc No: 2022-18072]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2544]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice; Quality System
Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on recordkeeping requirements
related to the medical devices current good manufacturing practice
(CGMP) quality system (QS) regulation (CGMP/QS regulation).

DATES: Either electronic or written comments on the collection of
information must be submitted by October 21, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 21, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2016-N-2544 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice; Quality System Regulation.'' 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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 information, including
each proposed extension of an existing collection of information,
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.

Medical Devices: Current Good Manufacturing Practice Quality System
Regulation--21 CFR Part 820

OMB Control Number 0910-0073--Extension

    As authorized under section 520(f) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360j(f)), the Secretary of the
Department of Health and Human Services has issued regulations
requiring that the methods used in, and the facilities and controls
used for, the manufacture, preproduction design validation (including a
process to assess the performance of a device, but not including an
evaluation of the safety and effectiveness of a device), packing,
storage, and installation of a device conform to CGMP, and assure that
the device will be safe and effective and otherwise in compliance with
the FD&C Act.
    The QSR under part 820 (21 CFR part 820) sets forth CGMP
requirements governing the design, manufacture, packing, labeling,
storage, installation, and servicing of all finished medical devices
intended for human use. The requirements cover purchasing and service
controls, clarify recordkeeping for device failure and complaint
investigations, clarify requirements for verifying/validating
production processes and process or product changes, and clarify
requirements for product acceptance activities, quality data
evaluations, and corrections of nonconforming product/quality problems.
In the Federal Register of February 23, 2022 (87 FR 10119), we proposed
to incorporate by reference International Organization for
Standardization 13485 (ISO 13485): Medical devices--Quality Management
Systems--Requirements for Regulatory Purposes, the 2016 edition, to the
QSR (RIN 0910-AH99), to align implementation of requirements.
    Information collection under the QSR is intended to assist FDA in
assuring the safety of medical devices. Requirements include
documenting the establishment of procedures and identifying required
records that assist FDA in determining whether firms are in compliance
with CGMP. In particular, for example, compliance with CGMP design
control requirements should decrease the number of design-related
device failures that have resulted in deaths and serious injuries.
Records must be made available for review or copying during FDA
inspection. The regulations in part 820 apply to approximately 29,424
respondents, based on current data within our device registration and
listing database.
    We estimate the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
    21 CFR part 820; required        Number of      records per    Total annual         per         Total hours
             records               recordkeepers   recordkeeper       records      recordkeeping
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QUALITY SYSTEM REQUIREMENTS--             29,424               1          29,424              83       2,442,192
 Subpart B......................
DESIGN CONTROLS--Subpart C......          29,424               1          29,424             132       3,883,968
DOCUMENT CONTROLS--Subpart D....          29,424               1          29,424              11         323,664
PURCHASING CONTROLS--Subpart E..          29,424               1          29,424              28         823,872
IDENTIFICATION & TRACEABILITY--           29,424               1          29,424               2          58,848
 Subpart F......................
PRODUCTION & PROCESS CONTROLS--           29,424               1          29,424              31         912,144
 Subpart G......................
ACCEPTANCE ACTIVITIES--Subpart H          29,424               1          29,424               6         176,544
NONCONFORMING PRODUCT;                    29,424               1          29,424              23         676,752
 CORRECTIVE & PREVENTATIVE
 ACTION--Subparts I and J.......
LABELING & PACKAGING CONTROLS--           29,424               1          29,424               3          88,272
 Subpart K......................
HANDLING, STORAGE, DISTRUBTION,           29,424               1          29,424              15         441,360
 & INSTALLATION--Subpart L......
RECORDS--Subpart M..............          29,424               1          29,424              10         294,240
SERVICING--Subpart N............          29,424               1          29,424               3          88,272
STATISTICAL TECHNIQUES--820.250--         29,424               1          29,424               1          29,424
 Subpart O......................
                                 -------------------------------------------------------------------------------
    Totals......................  ..............  ..............  ..............  ..............      10,239,552
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall increase of 1,217,800 hours. We made this adjustment to
correspond with an observed increase in submissions relating to medical
devices and an increase in respondents in the medical device industry
since last OMB review and approval of the information collection.

    Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18072 Filed 8-19-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Page 38288]
[FR Doc No: 2014-15698]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-502-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on June 17, 2014, Columbia Gas Transmission, LLC
(Columbia), 5151 San Felipe, Suite 2500, Houston, TX 77056, filed a
prior notice application pursuant to section 7(b) of the Natural Gas
Act (NGA) and sections 157.205 and 157.216 of the Federal Energy
Regulatory Commission's (Commission) regulations under the NGA, and
Columbia's blanket certificate issued in Docket No. CP83-76-000, for
authorization to abandon by removal four compressor units and various
appurtenant facilities and structures at Huff Creek Compressor Station
situated in Wyoming County, West Virginia, all as more fully set forth
in the application, which is open to the public for inspection. The
filing may also be viewed on the Web at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Fredric J. George, Senior Counsel, Columbia Gas Transmission, LLC, P.O.
Box 1273, Charleston, West Virginia 25325-1273, or phone<PHONE_NUMBER>
or fax<PHONE_NUMBER> or by email<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to Section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenter will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.

    Dated: June 27, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-15698 Filed 7-3-14; 8:45 am]
BILLING CODE 6717-01-P