Principles of Premarket Pathways for Combination Products; Guidance for Industry and Food and Drug Administration Staff; Availability, 4895-4897 [2022-01925]
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Fire Fighter Fatality Investigation and
Prevention Program (FFFIPP) Survey—
New—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The FFFIPP conducts independent
investigations of fire fighter (FF) line-ofduty deaths and recommends ways to
prevent deaths and injuries. In 2003, an
evaluation was conducted to determine
This data collection will assess FD
implementation of the NIOSH FFFIPP
recommendations and identify barriers
to implementation of recommendations.
Results will provide an understanding
of current FD operational procedures,
insight into motor vehicle-related
activities and related policies and
identify whether FFFIPP
recommendations are being utilized by
FDs. Findings will inform strategies for
communication of future
recommendations and identify areas for
potential intervention projects in order
to improve the delivery of services and
help ensure an effective and efficient
stakeholder experience with the FFFIPP.
The estimate for burden hours is
based on a pilot test of the survey
instrument by eight FD personnel. In the
pilot test, the average time to complete
the survey including time for reviewing
instructions, gathering needed
information, and completing the survey
was 10–25 minutes. For the purposes of
estimating burden hours, the upper
limit of this range is used. There are
screening questions at the beginning of
the survey so all respondents may not
actually participate.
The respondent universe is based on:
(1) 4,500 FDs, (2) eight strata (region,
department type), and (3) position (FF,
chief, company officer). An estimated
13,500 respondents are anticipated to
participate in the survey. The annual
respondent burden is estimated to be
4,050 hours.
the extent to which recommendations
from NIOSH investigations of FF
fatalities are being implemented by fire
departments (FDs). Since then, there
have been changes to the FFFIPP
recommendations and methods of
disseminating FFFIPP reports. For
example, there have been changes to: (1)
The details and types of
recommendations for preventing FF
fatalities, and (2) the method to
disseminate the FFFIPP reports to FDs
(driven in large part by cost).
Dissemination methods have evolved
from hardcopy mailings to FDs to
internet-based, with notifications of new
FFFIPP reports by the fire service media
and if FDs sign-up at the NIOSH website
for notifications of new reports.
Understanding how or if NIOSH
recommendations are used by various
types of FDs will allow a better
understanding of barriers to the use of
proven prevention recommendations
and help identify approaches to
improve the delivery of services to FDs.
Additionally, we will gain insight into
whether changes to the communication
and dissemination have impacted the
reach of these recommendations.
Knowing if different types of FDs are
aware of and willing to access FFFIPP
reports and recommendations in nonprint formats is critical, as these
recommendations cannot have the
intended impact of saving FF lives if
large numbers of FDs do not know
where to find NIOSH reports or have the
resources to access them.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Fire Fighters ......................................
Fire Chiefs .........................................
Company Officers .............................
Survey ..............................................
Survey ..............................................
Survey ..............................................
4,500
4,500
4,500
1
1
1
18/60
18/60
18/60
1,350
1,350
1,350
Total ...........................................
...........................................................
........................
........................
........................
4,050
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2022–01825 Filed 1–28–22; 8:45 am]
[Docket No. FDA–2019–D–0078]
BILLING CODE 4163–18–P
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Number of
responses per
respondent
Type of respondents
Principles of Premarket Pathways for
Combination Products; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Sep<11>2014
17:38 Jan 28, 2022
Jkt 256001
PO 00000
Notice of availability.
Frm 00064
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The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry and FDA staff
entitled ‘‘Principles of Premarket
Pathways for Combination Products.’’
This guidance presents FDA’s current
thinking on principles for premarket
review of combination products. This
guidance includes general, high-level
information regarding what combination
products are, coordination within FDA
and interaction between FDA and
sponsors regarding combination product
regulation, and how combination
products are reviewed by FDA before
SUMMARY:
E:\FR\FM\31JAN1.SGM
31JAN1
4896
Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices
they are marketed. The guidance also
includes recommendations on how to
determine which type of premarket
submissions may be appropriate for
combination products. FDA is
publishing this guidance as part of its
efforts to implement the 21st Century
Cures Act (Cures Act) and in keeping
with the Agency’s long-standing
commitment to transparency, efficiency,
and regulatory consistency to facilitate
development of safe and effective
combination products. This guidance
finalizes the draft guidance of the same
title that published on February 6, 2019.
DATES: The announcement of the
guidance is published in the Federal
Register on January 31, 2022.
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’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
17:38 Jan 28, 2022
Jkt 256001
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–0078 for ‘‘Principles of
Premarket Pathways for Combination
Products.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Office of
Combination Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring,
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: John
Barlow Weiner, Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring,
MD 20993–0002, 301–796–8930,
john.weiner@fda.hhs.gov or
combination@fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry and FDA staff
entitled ‘‘Principles of Premarket
Pathways for Combination Products.’’
This guidance presents FDA’s current
thinking on principles for premarket
review of combination products. This
guidance includes general, high-level
information regarding what combination
products are, coordination within FDA
and interaction between FDA and
sponsors regarding combination product
regulation, and how combination
products are reviewed by FDA before
they are marketed. The guidance also
includes recommendations on how to
determine which type of premarket
submissions may be appropriate for
combination products, as well as
illustrative examples.
Section 3038 of the Cures Act (Pub. L.
114–255), enacted in December 2016,
substantially amended section 503(g) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 353(g)), the
principal section of the FD&C Act
expressly addressing combination
products. General themes of these
amendments include enhancing clarity,
predictability, efficiency, and
consistency of premarket regulatory
expectations for combination products,
including by ensuring that Agency
components and staff coordinate
appropriately on premarket review of
these products, and that Agency
thinking is aligned in conducting these
reviews. This guidance is part of FDA’s
efforts to implement section 3038 of the
Cures Act.
In the Federal Register of February 6,
2019 (84 FR 2236), FDA announced the
availability of the draft guidance of the
same title. FDA received comments and
considered those comments as the
guidance was finalized. The final
guidance clarifies the guidance
including its applicability across
combination product types and
additional detail regarding processes for
interacting with the Agency.
E:\FR\FM\31JAN1.SGM
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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 ‘‘Principles of
Premarket Pathways for Combination
Products.’’ 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 3 and in the
guidance ‘‘How to Prepare a Pre-Request
for Designation (Pre-RFD)’’ have been
approved under OMB control number
0910–0523. The collections of
information for applications for FDA
approval to market a new drug (certain
provisions of 21 CFR part 314) have
been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR part 601 have
been approved under 0910–0338; and
the collections of information in section
351(k) of the Public Health Service Act
(42 U.S.C. 262) have been approved
under 0910–0719. The collections of
information in 21 CFR part 807, subpart
E, have been approved under OMB
control number 0910–0120; the
collections of information in 21 CFR
part 814, subparts A through E, have
been approved under OMB control
number 0910–0231; the collections of
information in 21 CFR part 860,
subparts A through C, have been
approved under OMB control number
0910–0138; the collections of
information in the guidance document
‘‘Requests for Feedback and Meetings
for Medical Device Submissions: The QSubmission Program’’ have been
approved under OMB control number
0910–0756; and the collections of
information in 21 CFR part 860, subpart
D, for De Novo classifications have been
approved under OMB control number
0910–0844.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/combination-products/
guidance-regulatory-information/
combination-products-guidance-
VerDate Sep<11>2014
17:38 Jan 28, 2022
Jkt 256001
documents, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01925 Filed 1–28–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0008]
Advisory Committee; Vaccines and
Related Biological Products Advisory
Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the Vaccines
and Related Biological Products
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Vaccines and
Related Biological Products Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
December 31, 2023, expiration date.
DATES: Authority for the Vaccines and
Related Biological Products Advisory
Committee will expire on December 31,
2023, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Prabhakara Atreya, Division of
Scientific Advisors and Consultants,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6306, Silver Spring,
MD 20993–0002, 240–402–8006,
Prabhakara.Atreya@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Vaccines and Related
Biological Products Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
SUMMARY:
PO 00000
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4897
discharging responsibilities as they
relate to helping to ensure safe and
effective vaccines and related biological
products for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
which are intended for use in the
prevention, treatment, or diagnosis of
human diseases, and, as required, any
other products for which FDA has
regulatory responsibility. The
Committee also considers the quality
and relevance of FDA’s research
program, which provides scientific
support for the regulation of these
products and makes appropriate
recommendations to the Commissioner.
The Committee shall consist of a core
of 15 voting members, including the
Chairperson (the Chair). Members and
the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of immunology, molecular biology,
rDNA, virology, bacteriology,
epidemiology or biostatistics, vaccine
policy, vaccine safety science, federal
immunization activities, vaccine
development including translational
and clinical evaluation programs,
allergy, preventive medicine, infectious
diseases, pediatrics, microbiology, and
biochemistry. Members will be invited
to serve for overlapping terms of up to
4 years. Almost all non-Federal
members of this committee serve as
Special Government Employees. Ex
Officio voting members, one each from
the Department of Health and Human
Services, the Centers for Disease Control
and Prevention, and the National
Institutes of Health may be included.
The core of voting members may
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests. There
may also be an alternate industry
representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) Expertise is required that is not
available among current voting standing
E:\FR\FM\31JAN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4895-4897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01925]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-0078]
Principles of Premarket Pathways for Combination Products;
Guidance for Industry and Food and Drug Administration Staff;
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 for industry and FDA staff
entitled ``Principles of Premarket Pathways for Combination Products.''
This guidance presents FDA's current thinking on principles for
premarket review of combination products. This guidance includes
general, high-level information regarding what combination products
are, coordination within FDA and interaction between FDA and sponsors
regarding combination product regulation, and how combination products
are reviewed by FDA before
[[Page 4896]]
they are marketed. The guidance also includes recommendations on how to
determine which type of premarket submissions may be appropriate for
combination products. FDA is publishing this guidance as part of its
efforts to implement the 21st Century Cures Act (Cures Act) and in
keeping with the Agency's long-standing commitment to transparency,
efficiency, and regulatory consistency to facilitate development of
safe and effective combination products. This guidance finalizes the
draft guidance of the same title that published on February 6, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on January 31, 2022.
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-2019-D-0078 for ``Principles of Premarket Pathways for Combination
Products.'' 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 this guidance to the
Office of Combination Products, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5129, 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 guidance document.
FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930,
[email protected] or [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Principles of Premarket Pathways for Combination
Products.'' This guidance presents FDA's current thinking on principles
for premarket review of combination products. This guidance includes
general, high-level information regarding what combination products
are, coordination within FDA and interaction between FDA and sponsors
regarding combination product regulation, and how combination products
are reviewed by FDA before they are marketed. The guidance also
includes recommendations on how to determine which type of premarket
submissions may be appropriate for combination products, as well as
illustrative examples.
Section 3038 of the Cures Act (Pub. L. 114-255), enacted in
December 2016, substantially amended section 503(g) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353(g)), the
principal section of the FD&C Act expressly addressing combination
products. General themes of these amendments include enhancing clarity,
predictability, efficiency, and consistency of premarket regulatory
expectations for combination products, including by ensuring that
Agency components and staff coordinate appropriately on premarket
review of these products, and that Agency thinking is aligned in
conducting these reviews. This guidance is part of FDA's efforts to
implement section 3038 of the Cures Act.
In the Federal Register of February 6, 2019 (84 FR 2236), FDA
announced the availability of the draft guidance of the same title. FDA
received comments and considered those comments as the guidance was
finalized. The final guidance clarifies the guidance including its
applicability across combination product types and additional detail
regarding processes for interacting with the Agency.
[[Page 4897]]
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 ``Principles of Premarket Pathways for
Combination Products.'' 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 3 and in the guidance ``How to Prepare a
Pre-Request for Designation (Pre-RFD)'' have been approved under OMB
control number 0910-0523. The collections of information for
applications for FDA approval to market a new drug (certain provisions
of 21 CFR part 314) have been approved under OMB control number 0910-
0001; the collections of information in 21 CFR part 601 have been
approved under 0910-0338; and the collections of information in section
351(k) of the Public Health Service Act (42 U.S.C. 262) have been
approved under 0910-0719. The collections of information in 21 CFR part
807, subpart E, have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 814, subparts A through
E, have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 860, subparts A through C,
have been approved under OMB control number 0910-0138; the collections
of information in the guidance document ``Requests for Feedback and
Meetings for Medical Device Submissions: The Q-Submission Program''
have been approved under OMB control number 0910-0756; and the
collections of information in 21 CFR part 860, subpart D, for De Novo
classifications have been approved under OMB control number 0910-0844.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01925 Filed 1-28-22; 8:45 am]
BILLING CODE 4164-01-P
