Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices, 10085-10087 [2021-03249]
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Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices
Annual Hours: 166. (For policy
questions regarding this collection
contact Shevi Marciano at 410–786–
2875.)
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: February 12, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–03257 Filed 2–17–21; 8:45 am]
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
Notice of Closed Meeting
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Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
SIP21–010, Engagement of Community
Health Workers to Reduce Racial
Discrimination and Improve
Hypertension Management.
Date: May 20, 2021.
Time: 11:00 a.m.–6:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
FOR FURTHER INFORMATION CONTACT: Jaya
Raman, Ph.D., Scientific Review Officer,
National Center for Chronic Disease
Prevention and Health Promotion, CDC,
4770 Buford Highway, Mailstop S107–8,
Atlanta, Georgia 30341, Telephone (770)
488–6511, JRaman@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
VerDate Sep<11>2014
17:47 Feb 17, 2021
Jkt 253001
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–03235 Filed 2–17–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Prevention and the Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2021–03236 Filed 2–17–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
10085
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel;
(SEP)—SIP21–009, Mental Health of
Mothers Study (MHOMS) and
Substance Use Evaluation Network.
Date: May 18, 2021.
Time: 11:00 a.m.–6:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
FOR FURTHER INFORMATION CONTACT: Jaya
Raman, Ph.D., Scientific Review Officer,
National Center for Chronic Disease
Prevention and Health Promotion, CDC,
4770 Buford Highway, Mailstop S107–8,
Atlanta, Georgia 30341, Telephone (770)
488–6511, JRaman@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
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Food and Drug Administration
[Docket No. FDA–2020–N–2231]
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 pertaining to
establishment registration and product
listing for manufacturers of human
blood and blood products and licensed
devices.
DATES: Submit either electronic or
written comments on the collection of
information by April 19, 2021.
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 April 19,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 19, 2021. 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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\18FEN1.SGM
18FEN1
10086
Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
• 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–2231 for ‘‘Establishment
Registration and Product Listing for
Manufacturers of Human Blood and
Blood Products and Licensed Devices—
21 CFR part 607.’’ 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
VerDate Sep<11>2014
17:47 Feb 17, 2021
Jkt 253001
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.
FOR FURTHER INFORMATION CONTACT:
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.
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.
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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 supports
Agency regulations. Under section 510
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360), any person owning
or operating an establishment that
manufactures, prepares, propagates,
compounds, or processes a drug or
device must register with the Secretary
of Health and Human Services, on or
before December 31 of each year, his or
her name, places of business, and all
such establishments, among other
information and must submit, a listing
of all drug and device products
manufactured, prepared, propagated,
compounded, or processed by him or
her for commercial distribution, among
other information. In 21 CFR part 607,
FDA has issued regulations
implementing these requirements for
manufacturers of human blood and
blood products.
The regulations set forth procedures
and requirements pertaining to
establishment registration and product
listing for manufacturers of human
blood and blood products and licensed
devices, including initial registration,
annual registration, product listing
updates, and waiver requests. Owners or
operators of certain establishments that
engage in the manufacture of blood
products shall 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,
E:\FR\FM\18FEN1.SGM
18FEN1
Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices
or any future superseding electronic
system, unless FDA has granted 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 submission is not reasonable
for the registrant (21 CFR 607.22(b)).
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
10087
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
607.20(a), 607.21, 607.22, 607.25, 607.40; Initial registration.
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); Waiver request .............................................
Total .......................................................................
1 There
Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03249 Filed 2–17–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0270]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Institutional
Foodservice and Retail Food Stores
Facility Types
Food and Drug Administration,
jbell on DSKJLSW7X2PROD with NOTICES
HHS.
ACTION:
Average burden
per response
(in hours)
Total annual
responses
Total hours
152
1
152
1 ...........................
152
2,557
1
2,557
0.5 (30 minutes) ...
1,279
256
1
256
1
1
1
1 ...........................
1
........................
........................
........................
..............................
1,496
0.25 (15 minutes)
64
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our evaluation of Fiscal Year
2019 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 slight
increase in submissions; however, the
overall burden has not changed.
AGENCY:
Number of
responses per
respondent
Number of
respondents
21 CFR section; information collection activity
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.
SUMMARY:
VerDate Sep<11>2014
17:47 Feb 17, 2021
Jkt 253001
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 Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Institutional
Foodservice and Retail Food Stores
Facility Types.
DATES: Submit either electronic or
written comments on the collection of
information by April 19, 2021.
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 April 19,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 19, 2021. 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,
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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.’’
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10085-10087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03249]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2231]
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
pertaining to establishment registration and product listing for
manufacturers of human blood and blood products and licensed devices.
DATES: Submit either electronic or written comments on the collection
of information by April 19, 2021.
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 April 19, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 19, 2021. 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:
[[Page 10086]]
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-2231 for ``Establishment Registration and Product Listing
for Manufacturers of Human Blood and Blood Products and Licensed
Devices--21 CFR part 607.'' 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: 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,
[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 supports Agency regulations. Under
section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360), any person owning or operating an establishment that
manufactures, prepares, propagates, compounds, or processes a drug or
device must register with the Secretary of Health and Human Services,
on or before December 31 of each year, his or her name, places of
business, and all such establishments, among other information and must
submit, a listing of all drug and device products manufactured,
prepared, propagated, compounded, or processed by him or her for
commercial distribution, among other information. In 21 CFR part 607,
FDA has issued regulations implementing these requirements for
manufacturers of human blood and blood products.
The regulations set forth procedures and requirements pertaining to
establishment registration and product listing for manufacturers of
human blood and blood products and licensed devices, including initial
registration, annual registration, product listing updates, and waiver
requests. Owners or operators of certain establishments that engage in
the manufacture of blood products shall 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,
[[Page 10087]]
or any future superseding electronic system, unless FDA has granted 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 submission is not reasonable for the
registrant (21 CFR 607.22(b)). 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\
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Number of
21 CFR section; information collection Number of responses per Total annual Average burden per response (in hours) Total hours
activity respondents respondent responses
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607.20(a), 607.21, 607.22, 607.25, 607.40; 152 1 152 1....................................... 152
Initial registration.
607.21, 607.22, 607.25, 607.26, 607.31, 2,557 1 2,557 0.5 (30 minutes)........................ 1,279
607.40; Annual registration.
607.21, 607.25, 607.30(a), 607.31, 607.40; 256 1 256 0.25 (15 minutes)....................... 64
Product listing update.
607.22(b); Waiver request..................... 1 1 1 1....................................... 1
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Total..................................... .............. .............. .............. ........................................ 1,496
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our evaluation of Fiscal Year 2019 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 slight increase in
submissions; however, the overall burden has not changed.
Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03249 Filed 2-17-21; 8:45 am]
BILLING CODE 4164-01-P
