Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices, 17856-17858 [2024-05215]
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17856
Federal Register / Vol. 89, No. 49 / Tuesday, March 12, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Agency guidance recommendations; information collection
Form FDA
No.
Number of
responses
per
respondent
Number of
respondents
Total annual
responses
Average
burden per
response
Total hours
Consultation Procedures: Foods Derived From New Plant Varieties
Initial consultation ..................................................................................
Final consultation ..................................................................................
None
3,665
30
12
2
1
60
12
4
150
240
1,800
Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
Six data components ............................................................................
3,666
6
1
6
20
120
Total ...............................................................................................
....................
........................
........................
78
........................
2,160
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made minor
adjustments to update our burden
estimate to reflect recent annual
response rates (increased initial
consultations under the New Plant
Variety consultation procedures) and to
clarify the total number of responses
under the Early Food Safety Evaluation
(NPC) procedures.
Dated: March 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05219 Filed 3–11–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
[Docket No. FDA–2024–N–0783]
Agency Information Collection
Activities; Proposed Collection;
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 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
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 the information
collection requirements in the Agency’s
regulations relating to establishment
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:11 Mar 11, 2024
Jkt 262001
registration and product listing for
manufacturers of human blood and
blood products and licensed devices.
DATES: Either electronic or written
comments on the collection of
information must be submitted by May
13, 2024.
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
May 13, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
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’’).
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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–
2024–N–0783 for ‘‘Establishment
Registration and Product Listing for
Manufacturers of Human Blood and
Blood Products and Licensed Devices.’’
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
E:\FR\FM\12MRN1.SGM
12MRN1
Federal Register / Vol. 89, No. 49 / Tuesday, March 12, 2024 / Notices
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.
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.
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
SUPPLEMENTARY INFORMATION:
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.
Establishment Registration and Product
Listing for Manufacturers of Human
Blood and Blood Products and Licensed
Devices—21 CFR Part 607
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 21 CFR part 607
and forms. All owners or operators of
establishments that manufacture human
blood and blood products are required
to register with the FDA, unless they are
exempt under 21 CFR 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,
17857
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 (21
CFR 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 eBER system is
available at: https://www.fda.gov/
vaccines-blood-biologics/biologicsestablishment-registration/bloodestablishment-registration-and-productlisting. 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 (21 CFR
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.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
21 CFR Section; activity
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.
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20:11 Mar 11, 2024
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PO 00000
Number of
responses per
respondent
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
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17858
Federal Register / Vol. 89, No. 49 / Tuesday, March 12, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Total annual
responses
Average burden per response
Total hours
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.
control number for this information
collection is 0910–0308. Also include
the FDA docket number found in
brackets in the heading of this
document.
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.
FOR FURTHER INFORMATION CONTACT:
Dated: March 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
Adverse Experience Reporting for
Licensed Biological Products; and
General Records—21 CFR Part 600
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
OMB Control Number 0910–0308—
Extension
[Docket No. FDA–2023–N–3847]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 April 11,
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
SUMMARY:
VerDate Sep<11>2014
19:36 Mar 11, 2024
Jkt 262001
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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.
[FR Doc. 2024–05215 Filed 3–11–24; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR Section; activity
This information collection helps
support implementation of statutory and
regulatory authorities that govern
adverse experience reporting. Under the
Public Health Service Act (PHS Act) (42
U.S.C. 262), FDA may only approve a
biologics license application for a
biological product that is safe, pure, and
potent. When a biological product is
approved and enters the market, the
product is introduced to a larger patient
population in settings different from
clinical trials. New information
generated during the postmarketing
period offers further insight into the
benefits and risks of the product, and
evaluation of this information is
important to ensure its safe use.
Regulations implementing adverse
experience reporting (AER)
requirements applicable to biological
products are codified in part 600 (21
CFR part 600). Regulations applicable to
combination products subject to
regulations in part 600 are found in part
4 (21 CFR part 4)—Regulation of
Combination Products. The collections
of information are intended to enable
FDA to take actions necessary for the
protection of the public health in
response to reports of adverse
experiences related to biologics licensed
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
under any provision of section 351 of
the PHS Act.
To assist respondents with the
reporting provisions of the information
collection, FDA has created both paperbased and electronic forms. Information
may be submitted electronically through
MEDWATCH or the Vaccine Adverse
Experience Reporting System (VAERS).
AER reports are filed using the
MEDWATCH Form FDA–3500A
(approved under OMB control numbers
0910–0291 and 0910–0645) or the
VAERS–1. Both versions of the forms
and instructions are available from the
internet at https://vaers.hhs.gov. The
forms may also be downloaded,
completed, and submitted to the Agency
by mail or facsimile.
For operational efficiency, on March
20, 2023, we requested, and OMB has
approved, the addition of burden
attributable to provisions set forth in
part 4, subpart B, previously included in
OMB control number 0910–0834. When
information regarding an event that
involves a death or serious injury, or an
adverse event, associated with the use of
the combination product is received by
the product sponsor, the information
must be provided to the other
constituent part applicant(s) no later
than 5 calendar days after receipt under
§ 4.103. Relatedly, § 4.104 explains how
and where to submit reports.
In the Federal Register of September
28, 2023 (88 FR 66856), we published a
60-day notice requesting public
comment on the proposed collection of
information. We received one comment
regarding our estimate of 28 hours per
response for periodic adverse
experience reports. The comment
suggested we lower that estimate but
provided no data or explanation in
support of the proposed reduction.
While we have therefore made no
adjustment in our burden estimate, we
encourage further comment regarding a
basis for assessing burden for the scope
of information collection activity
covered by the applicable regulations
and associated forms.
Respondents: Respondents to this
collection of information are
manufacturers of biological products
(including blood and blood
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]]>Agencies
[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17856-17858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05215]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0783]
Agency Information Collection Activities; Proposed Collection;
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 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 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 the information collection requirements in
the Agency's regulations relating to establishment registration and
product listing for manufacturers of human blood and blood products and
licensed devices.
DATES: Either electronic or written comments on the collection of
information must be submitted by May 13, 2024.
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 May 13, 2024. 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-2024-N-0783 for ``Establishment Registration and Product Listing
for Manufacturers of Human Blood and Blood Products and Licensed
Devices.'' 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
[[Page 17857]]
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: 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: 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.
Establishment Registration and Product Listing for Manufacturers of
Human Blood and Blood Products and Licensed Devices--21 CFR Part 607
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 21 CFR part 607 and forms. All owners
or operators of establishments that manufacture human blood and blood
products are required to register with the FDA, unless they are exempt
under 21 CFR 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 (21 CFR 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 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 (21 CFR 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.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
607.20(a), 607.21, 607.22, 176 1 176 1............... 176
607.25, 607.40; Initial
registration and submission
of product listing.
607.21, 607.22, 607.25, 2,545 1 2,545 0.5 (30 minutes) 1,273
607.26, 607.31, 607.40;
Annual registration.
607.21, 607.25, 607.30(a), 42 1 42 0.25 (15 10
607.31, 607.40; Product minutes).
listing update.
[[Page 17858]]
607.22(b); Written waiver 1 1 1 1............... 1
request.
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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: March 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05215 Filed 3-11-24; 8:45 am]
BILLING CODE 4164-01-P
