Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices, 52063-52064 [2024-13643]
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Federal Register / Vol. 89, No. 120 / Friday, June 21, 2024 / Notices
2013–D–0710 for ‘‘Circumstances That
Constitute Delaying, Denying, Limiting,
or Refusing a Drug or Device
Inspection.’’ Received comments 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-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for a single
hard copy of the guidance entitled
‘‘Circumstances That Constitute
Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection’’
to the Office of Policy, Compliance and
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
VerDate Sep<11>2014
17:46 Jun 20, 2024
Jkt 262001
12420 Parklawn Drive, Element
Building, Rockville, MD 20857. Send
one self-addressed adhesive label to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Lola
Burford, Office of Regulatory Affairs,
Division of Operational Policy, Food
and Drug Administration, 12420
Parklawn Drive, Element Building,
Rockville, MD 20857, Lola.Burford@
fda.hhs.gov, 240–402–5865.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the Food and Drug
Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112–144) added
section 501(j) to the FD&C Act (21
U.S.C. 351(j)) to deem adulterated a
drug that ‘‘has been manufactured,
processed, packed, or held in any
factory, warehouse, or establishment
and the owner, operator, or agent of
such factory, warehouse, or
establishment delays, denies, or limits
an inspection, or refuses to permit entry
or inspection.’’ Section 707(b) of
FDASIA required the Food and Drug
Administration to issue guidance that
defined the circumstances that would
constitute delaying, denying, or limiting
inspection, or refusing to permit entry
or inspection, for purposes of section
501(j). In the Federal Register of
October 22, 2014 (79 FR 63130), FDA
announced the availability of a guidance
for industry entitled, ‘‘Circumstances
That Constitute Delaying, Denying,
Limiting, or Refusing a Drug Inspection’’
(hereinafter, 2014 guidance).
Subsequently, on August 18, 2017,
FDARA (Pub. L. 115–52) was signed
into law. Section 702 of FDARA
amended the scope of section 501(j) of
the FD&C Act to provide that, as the
case with drugs, devices are deemed to
be adulterated if an FDA inspection is
delayed, denied, limited, or refused by
the owner, operator, or agent of the
establishment at which the device is
manufactured, processed, packed, or
held. This final guidance supersedes the
2014 final guidance to incorporate
devices and to explain the
circumstances that FDA would consider
to constitute delaying, denying, or
limiting inspection, or refusing to
permit entry or inspection, resulting in
a drug or device manufactured in the
facility being deemed adulterated.
This final guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
FDA considered the comments received
on the draft guidance and did not make
substantial changes from the draft to the
PO 00000
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52063
final guidance. This final guidance
represents the current thinking of FDA
on ‘‘Circumstances That Constitute
Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/search-general-and-crosscutting-topics-guidance-documents or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Circumstances That Constitute
Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection’’
may send an email request to
ORAPolicyStaffs@fda.hhs.gov to receive
an electronic copy of the document.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13674 Filed 6–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0783]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Establishment
Registration and Product Listing for
Manufacturers of Human Blood and
Blood Products and Licensed Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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
SUMMARY:
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52064
Federal Register / Vol. 89, No. 120 / Friday, June 21, 2024 / Notices
collection of information by July 22,
2024.
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 OMB
control number for this information
collection is 0910–0052. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Establishment Registration and Product
Listing for Manufacturers of Human
Blood and Blood Products and Licensed
Devices
OMB Control Number 0910–0052—
Extension
This information collection helps
support implementation of section 510
of the Federal Food Drug and Cosmetic
Act (21 U.S.C. 360), as well as related
Agency regulations in part 607 (21 CFR
product-listing. Online instructions are
available at: https://www.fda.gov/
media/116432/download?attachment.
The Form FDA 2830 previously
associated with this information
collection is no longer in use.
FDA may grant a request for waiver of
this requirement prior to the date on
which the information is due
(§ 607.22(a)). Waiver requests must be
submitted in writing and must include,
among other information, the specific
reasons why electronic registration is
not reasonable for the registrant.
Establishment registration and
product listing information assists FDA
in its inspections of facilities, among
other uses, and its collection is essential
to the overall regulatory scheme
designed to ensure the safety of the
Nation’s blood supply.
Description of Respondents:
Respondents to this collection of
information are human blood and
plasma donor centers, blood banks,
certain transfusion services, other blood
product manufacturers, independent
laboratories that engage in quality
control and testing for registered blood
product establishments and
manufacturers of devices licensed under
section 351 of the Public Health Service
Act.
In the Federal Register of March 12,
2024 (89 FR 17856), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
part 607) and forms. All owners or
operators of establishments that
manufacture human blood and blood
products are required to register with
FDA, unless they are exempt under
§ 607.65. A list of every blood product
manufactured, prepared, or processed
for commercial distribution must also be
submitted, among other information.
Establishments must register within 5
days after beginning operations or
submission of a biologics license
application and register annually
between October 1 and December 31.
The regulations set forth procedures
and requirements pertaining to
establishment registration and product
listing for manufactures of human blood
and blood products and licensed
devices, including initial registration
and product listing, annual registration,
product listing updates and waiver
requests. Owners or operators of certain
establishments that engage in the
manufacture of blood products must
register and submit a list of every blood
product in commercial distribution
(§ 607.20(a)). Initial and subsequent
registrations and product listings must
be submitted electronically through
FDA’s Center for Biologics Evaluation
and Research (CBER) Blood
Establishment Registration and Product
Listing system through the FDA
Industry Systems page available at
https://www.access.fda.gov. More
information about the electronic blood
establishment registration (eBER)
system is available at: https://
www.fda.gov/vaccines-blood-biologics/
biologics-establishment-registration/
blood-establishment-registration-and-
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
607.20(a), 607.21, 607.22, 607.25, 607.40; Initial registration and submission of product
listing.
607.21, 607.22, 607.25, 607.26, 607.31,
607.40; Annual registration.
607.21, 607.25, 607.30(a), 607.31, 607.40;
Product listing update.
607.22(b); Written waiver request ....................
Total ...........................................................
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total annual
responses
Average burden per
response
Total hours
176
1
176
1 ........................................
176
2,545
1
2,545
0.5 (30 minutes) ...............
1,273
42
1
42
0.25 (15 minutes) .............
10
1
1
1
1 ........................................
1
........................
........................
........................
...........................................
1,460
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our evaluation of calendar
year 2022 data from CBER’s Blood
Establishment Registration and Product
Listing system, we have adjusted the
currently approved burden estimate we
attribute to establishment registration
and product listing to reflect a decrease
in product listing updates and an
VerDate Sep<11>2014
17:46 Jun 20, 2024
Jkt 262001
increase in the number of initial
registrations. Our estimated burden for
the information collection reflects an
overall decrease of 36 hours.
PO 00000
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13643 Filed 6–20–24; 8:45 am]
BILLING CODE 4164–01–P
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Agencies
[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52063-52064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13643]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0783]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishment
Registration and Product Listing for Manufacturers of Human Blood and
Blood Products and Licensed Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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
[[Page 52064]]
collection of information by July 22, 2024.
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 OMB control number for
this information collection is 0910-0052. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
Establishment Registration and Product Listing for Manufacturers of
Human Blood and Blood Products and Licensed Devices
OMB Control Number 0910-0052--Extension
This information collection helps support implementation of section
510 of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360), as well
as related Agency regulations in part 607 (21 CFR part 607) and forms.
All owners or operators of establishments that manufacture human blood
and blood products are required to register with FDA, unless they are
exempt under Sec. 607.65. A list of every blood product manufactured,
prepared, or processed for commercial distribution must also be
submitted, among other information. Establishments must register within
5 days after beginning operations or submission of a biologics license
application and register annually between October 1 and December 31.
The regulations set forth procedures and requirements pertaining to
establishment registration and product listing for manufactures of
human blood and blood products and licensed devices, including initial
registration and product listing, annual registration, product listing
updates and waiver requests. Owners or operators of certain
establishments that engage in the manufacture of blood products must
register and submit a list of every blood product in commercial
distribution (Sec. 607.20(a)). Initial and subsequent registrations
and product listings must be submitted electronically through FDA's
Center for Biologics Evaluation and Research (CBER) Blood Establishment
Registration and Product Listing system through the FDA Industry
Systems page available at https://www.access.fda.gov. More information
about the electronic blood establishment registration (eBER) system is
available at: https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing. Online instructions are available at: https://www.fda.gov/media/116432/download?attachment. The Form FDA 2830
previously associated with this information collection is no longer in
use.
FDA may grant a request for waiver of this requirement prior to the
date on which the information is due (Sec. 607.22(a)). Waiver requests
must be submitted in writing and must include, among other information,
the specific reasons why electronic registration is not reasonable for
the registrant.
Establishment registration and product listing information assists
FDA in its inspections of facilities, among other uses, and its
collection is essential to the overall regulatory scheme designed to
ensure the safety of the Nation's blood supply.
Description of Respondents: Respondents to this collection of
information are human blood and plasma donor centers, blood banks,
certain transfusion services, other blood product manufacturers,
independent laboratories that engage in quality control and testing for
registered blood product establishments and manufacturers of devices
licensed under section 351 of the Public Health Service Act.
In the Federal Register of March 12, 2024 (89 FR 17856), FDA
published a 60-day notice requesting public 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 \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
607.20(a), 607.21, 607.22, 607.25, 176 1 176 1............................................ 176
607.40; Initial registration and
submission of product listing.
607.21, 607.22, 607.25, 607.26, 607.31, 2,545 1 2,545 0.5 (30 minutes)............................. 1,273
607.40; Annual registration.
607.21, 607.25, 607.30(a), 607.31, 42 1 42 0.25 (15 minutes)............................ 10
607.40; Product listing update.
607.22(b); Written waiver request........ 1 1 1 1............................................ 1
--------------------------------------------------------------------------------------------------------------
Total................................ .............. .............. .............. ............................................. 1,460
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our evaluation of calendar year 2022 data from CBER's
Blood Establishment Registration and Product Listing system, we have
adjusted the currently approved burden estimate we attribute to
establishment registration and product listing to reflect a decrease in
product listing updates and an increase in the number of initial
registrations. Our estimated burden for the information collection
reflects an overall decrease of 36 hours.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13643 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P