Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry; Availability, 64234-64236 [2022-23057]
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Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of
disclosures
per
respondent
Number of
respondents
Activity/21 CFR section
Notification of facilities that AB relinquishes its accreditation—900.3(f)(2).
Clinical images; facility 2—900.4(c), 900.11(b)(1), and
900.11(b)(2).
Clinical images; AB 3—900.4(c) ....................................
Phantom images; facility 2—900.4(d), 900.11(b)(1),
and 900.11(b)(2).
Phantom images; AB 3—900.4(d) .................................
Annual equipment evaluation and survey; facility 2—
900.4(e), 900.11(b)(1), and 900.11(b)(2).
Annual equipment evaluation and survey; AB 3—
900.4(e).
Provisional mammography facility certificate extension
application—900.11(b)(3).
Mammography facility certificate reinstatement application—900.11(c).
Lay summary of examination—900.12(c)(2) .................
Lay summary of examination; patient refusal 4—
900.12(c)(2).
Report
of
unresolved
serious
complaints—
900.12(h)(4).
Information regarding compromised quality; facility 2—
900.12(j)(1).
Information regarding compromised quality; AB 3—
900.12(j)(1).
Patient notification of serious risk—900.12(j)(2) ...........
Reconsideration of accreditation—900.15(c) ................
Notification of requirement to correct major deficiencies—900.24(a).
Notification of loss of approval; major deficiencies—
900.24(a)(2).
Notification of probationary status—900.24(b)(1) .........
Notification of loss of approval; minor deficiencies—
900.24(b)(3).
Total .......................................................................
Average
burden per
disclosure
Total annual
disclosures
Total hours 1
0.1
1
0.1
200 .......................
20
2,885
1
2,885
1.44 ......................
4,154
5
2,885
1
1
5
2,885
416 .......................
0.72 (43 minutes)
2,080
2,077
5
8,718
1
1
5
8,718
208 .......................
1 ...........................
1,040
8,718
5
1
5
1,730 ....................
8,650
0
1
0
0.5 (30 minutes) ...
1
281
1
281
5 ...........................
1,405
8,718
87
5,085
1
44,331,030
87
0.083 (5 minutes)
0.5 (30 minutes) ...
3,679,475
44
20
1
20
1 ...........................
20
20
1
20
200 .......................
4,000
20
1
20
320 .......................
6,400
5
5
0.4
1
1
1
5
5
0.4
100 .......................
2 ...........................
200 .......................
500
10
80
0.15
1
0.15
100 .......................
15
0.3
0.15
1
1
0.3
0.15
200 .......................
100 .......................
60
15
........................
........................
........................
..............................
3,718,764
1 Total
hours have been rounded.
to the facility component of the burden for this requirement.
to the AB component of the burden for this requirement.
4 Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.
2 Refers
lotter on DSK11XQN23PROD with NOTICES1
3 Refers
Respondents use the Mammography
Program Reporting and Information
System to submit information. Our
estimated burden for the information
collection reflects an overall increase of
28,664 hours and a corresponding
increase of 9,137,449 responses/records.
We attribute this adjustment to an
increase in the number of submissions
we received over the last few years. We
do not include burden for
§§ 900.12(c)(1) and (3), 900.3(f)(1), and
900.24(c) because if a certifying State
had its approval withdrawn, FDA would
take over certifying authority for the
affected facilities. Because FDA already
has all the certifying State’s electronic
records, we assume no additional
reporting burden.
Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23028 Filed 10–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2101]
Human Gene Therapy for
Neurodegenerative Diseases;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
SUMMARY:
VerDate Sep<11>2014
17:07 Oct 21, 2022
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Frm 00036
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guidance entitled ‘‘Human Gene
Therapy for Neurodegenerative
Diseases; Guidance for Industry.’’
Neurodegenerative diseases are a
heterogeneous group of disorders
characterized by progressive
degeneration of the structure and
function of the central nervous system
or peripheral nervous system. The
guidance document provides
recommendations to sponsors
developing human gene therapy (GT)
products for neurodegenerative diseases
affecting adult and pediatric patients.
The guidance focuses on considerations
for product development, preclinical
testing, and clinical trial design. The
guidance announced in this notice
finalizes the draft guidance of the same
title dated January 2021.
The announcement of the
guidance is published in the Federal
Register on October 24, 2022.
DATES:
E:\FR\FM\24OCN1.SGM
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Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
lotter on DSK11XQN23PROD with NOTICES1
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–D–2101 for ‘‘Human Gene
Therapy for Neurodegenerative
Diseases; Guidance for Industry.’’
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
VerDate Sep<11>2014
17:07 Oct 21, 2022
Jkt 259001
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 single
copies of the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Phillip Kurs, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
64235
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Human Gene
Therapy for Neurodegenerative
Diseases; Guidance for Industry.’’
Neurodegenerative diseases are a
heterogeneous group of disorders
characterized by progressive
degeneration of the structure and
function of the central nervous system
or peripheral nervous system. These
diseases vary in etiology, prevalence,
diagnosis, and management, and
include genetic as well as age-related
diseases. The guidance document
provides recommendations to sponsors
developing a GT product for
neurodegenerative diseases affecting
adult and pediatric patients. The
guidance focuses on considerations for
product development, preclinical
testing, and clinical trial design.
In the Federal Register of January 6,
2021 (86 FR 549), FDA announced the
availability of the draft guidance of the
same title dated January 2021. FDA
received several comments on the draft
guidance and those comments were
considered as the guidance was
finalized. Changes to the guidance
include clarifications to the
recommendations regarding use of
tumorigenic cell lines, comparability
studies, and crossover designs for
clinical trials. In addition, editorial
changes were made to improve clarity.
The guidance announced in this notice
finalizes the draft guidance dated
January 2021.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Human Gene
Therapy for Neurodegenerative
Diseases.’’ 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
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 50 have been
E:\FR\FM\24OCN1.SGM
24OCN1
64236
Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
approved under OMB control number
0910–0130; the collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338; and the collections
of information in the guidance entitled
‘‘Expedited Programs for Serious
Conditions—Drugs and Biologics’’ have
been approved under OMB control
number 0910–0765.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23057 Filed 10–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidances; Draft and
Revised Draft Guidances for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of
additional draft and revised draft
product-specific guidances for
developing topical products applied to
the skin, as well as integumentary and
mucosal (e.g., vaginal) membranes. The
guidances provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs). In the
Federal Register of June 11, 2010, FDA
announced the availability of a guidance
for industry entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific guidances available to the
public on FDA’s website. The guidances
identified in this notice were developed
using the process described in that
guidance.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:07 Oct 21, 2022
Jkt 259001
Submit either electronic or
written comments on the draft
guidances by December 23, 2022 to
ensure that the Agency considers your
comment on these draft guidances
before it begins work on the final
versions of the guidances.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
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–
2007–D–0369 for ‘‘Product-Specific
Guidances; Draft and Revised Draft
Guidances for Industry.’’ 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.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
• 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 single
copies of the draft guidances to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance documents.
FOR FURTHER INFORMATION CONTACT:
Christine Le, Center for Drug Evaluation
and Research (HFD–880), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714,
Silver Spring, MD 20993–0002, 301–
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64234-64236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23057]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-2101]
Human Gene Therapy for Neurodegenerative Diseases; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Human Gene Therapy for
Neurodegenerative Diseases; Guidance for Industry.'' Neurodegenerative
diseases are a heterogeneous group of disorders characterized by
progressive degeneration of the structure and function of the central
nervous system or peripheral nervous system. The guidance document
provides recommendations to sponsors developing human gene therapy (GT)
products for neurodegenerative diseases affecting adult and pediatric
patients. The guidance focuses on considerations for product
development, preclinical testing, and clinical trial design. The
guidance announced in this notice finalizes the draft guidance of the
same title dated January 2021.
DATES: The announcement of the guidance is published in the Federal
Register on October 24, 2022.
[[Page 64235]]
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2020-D-2101 for ``Human Gene Therapy for Neurodegenerative
Diseases; Guidance for Industry.'' 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-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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Phillip Kurs, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled ``Human
Gene Therapy for Neurodegenerative Diseases; Guidance for Industry.''
Neurodegenerative diseases are a heterogeneous group of disorders
characterized by progressive degeneration of the structure and function
of the central nervous system or peripheral nervous system. These
diseases vary in etiology, prevalence, diagnosis, and management, and
include genetic as well as age-related diseases. The guidance document
provides recommendations to sponsors developing a GT product for
neurodegenerative diseases affecting adult and pediatric patients. The
guidance focuses on considerations for product development, preclinical
testing, and clinical trial design.
In the Federal Register of January 6, 2021 (86 FR 549), FDA
announced the availability of the draft guidance of the same title
dated January 2021. FDA received several comments on the draft guidance
and those comments were considered as the guidance was finalized.
Changes to the guidance include clarifications to the recommendations
regarding use of tumorigenic cell lines, comparability studies, and
crossover designs for clinical trials. In addition, editorial changes
were made to improve clarity. The guidance announced in this notice
finalizes the draft guidance dated January 2021.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Human Gene Therapy for Neurodegenerative
Diseases.'' 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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 50 have been
[[Page 64236]]
approved under OMB control number 0910-0130; the collections of
information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 601
have been approved under OMB control number 0910-0338; and the
collections of information in the guidance entitled ``Expedited
Programs for Serious Conditions--Drugs and Biologics'' have been
approved under OMB control number 0910-0765.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23057 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P
