Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey, 20980-20982 [2024-06316]
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<![CDATA[
20980
Federal Register / Vol. 89, No. 59 / Tuesday, March 26, 2024 / Notices
OMB has now approved the information
collection and has assigned OMB
control number 0910–0623. The
approval expires on February 28, 2027.
A copy of the supporting statement for
this information collection is available
on the internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: March 21, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06395 Filed 3–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–P–4636]
Determination That ISUPREL
(Isoproterenol Hydrochloride)
Injection, 0.2 Milligrams per Milliliter,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that ISUPREL
(isoproterenol hydrochloride) injection,
0.2 milligrams (mg)/milliliter (mL), was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for ISUPREL
(isoproterenol hydrochloride) injection,
0.2 mg/mL, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Veniqua Stewart, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219,
Silver Spring, MD 20993–0002, 301–
796–3627, Veniqua.Stewart@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
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have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness
(21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ISUPREL (isoproterenol
hydrochloride) injection, 0.2 mg/mL, is
the subject of NDA 010515, held by
Bausch Health US, LLC, and was
initially approved on May 25, 1956.
ISUPREL injection is indicated to
improve hemodynamic status in
patients in distributive shock and shock
due to reduced cardiac output, and is
also indicated for bronchospasm
occurring during anesthesia. ISUPREL
(isoproterenol hydrochloride) injection,
0.2 mg/mL, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
E. Rust Consulting, LLC submitted a
citizen petition dated October 20, 2023
(Docket No. FDA–2023–P–4636), under
21 CFR 10.30, requesting that the
Agency determine whether ISUPREL
(isoproterenol hydrochloride) injection,
0.2 mg/mL, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ISUPREL (isoproterenol
hydrochloride) injection, 0.2 mg/mL,
was not withdrawn for reasons of safety
or effectiveness. The petitioner has
identified no data or other information
suggesting that ISUPREL (isoproterenol
hydrochloride) injection, 0.2 mg/mL,
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of ISUPREL
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(isoproterenol hydrochloride) injection,
0.2 mg/mL, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ISUPREL (isoproterenol
hydrochloride) injection, 0.2 mg/mL, in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to ISUPREL (isoproterenol
hydrochloride) injection, 0.2 mg/mL,
may be approved by the Agency as long
as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06311 Filed 3–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0846]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; National
Agriculture and Food Defense Strategy
Survey
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 for a voluntary
SUMMARY:
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Federal Register / Vol. 89, No. 59 / Tuesday, March 26, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
survey for the Department of Health and
Human Services (HHS), the U.S.
Department of Agriculture (USDA), and
the Department of Homeland Security
(DHS), which will inform the FDA Food
Safety Modernization Act (FSMA),
National Agriculture and Food Defense
Strategy (NAFDS) Report to Congress.
The proposed survey will be used to
determine what food defense activities,
if any, State, local, territorial, and/or
tribal (SLTT) agencies have completed
to date. The information will be
compared to the initial baseline data
previously collected by State(s).
DATES: Either electronic or written
comments on the collection of
information must be submitted by May
28, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 28, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
VerDate Sep<11>2014
18:10 Mar 25, 2024
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Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–0846 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; National
Agriculture and Food Defense Strategy
Survey.’’ 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
PO 00000
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20981
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
240–402–7500.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St,
North Bethesda, MD 20852, 301–796–
3794, 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.
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.
National Agriculture and Food Defense
Strategy Survey
OMB Control Number 0910–0855—
Extension
We are seeking OMB approval of the
NAFDS under section 108 of FSMA.
This is a voluntary survey of SLTT
governments intended to gauge
government activities in food and
agriculture defense from intentional
contamination and emerging threats.
The collected information will be
included in the mandatory NAFDS
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20982
Federal Register / Vol. 89, No. 59 / Tuesday, March 26, 2024 / Notices
followup Report to Congress. The
authority for us to collect the
information derives from the
Commissioner of Food and Drugs’
authority provided in section
1003(d)(2)(C) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(C)).
Protecting the nation’s food and
agriculture supply against intentional
contamination and other emerging
threats is an important responsibility
shared by SLTT governments as well as
private sector partners. FSMA focuses
on ensuring the safety of the U.S. food
supply by shifting the efforts of Federal
regulators from response to prevention
and recognizes the importance of
strengthening existing collaboration
among all stakeholders to achieve
common public health and security
goals. FSMA identifies some key
priorities for working with partners in
areas such as reliance on Federal, State,
and local agencies for inspections;
improving foodborne illness
surveillance; and leveraging and
enhancing State and local food safety
and defense capacities. Section 108 of
FSMA–NAFDS requires HHS and
USDA, in coordination with DHS, to
work together with SLTT to monitor and
measure progress in food defense.
In 2015, the initial NAFDS Report to
Congress detailed the specific Federal
response to food and agriculture defense
goals, objectives, key initiatives, and
activities that HHS, USDA, DHS, and
other stakeholders planned to
accomplish to meet the objectives
outlined in FSMA. The NAFDS charts a
direction for how Federal agencies, in
cooperation with SLTT governments
and private sector partners, protect the
nation’s food supply against intentional
contamination. Not later than 4 years
after the initial NAFDS Report to
Congress (2015), and every 4 years
thereafter (i.e., 2019, 2023, 2027, etc.),
HHS, USDA, and DHS are required to
revise and submit an updated report to
the relevant committees of Congress.
FDA is the agency primarily
responsible for obtaining the
information from Federal and SLTT
partners to complete the NAFDS Report
to Congress. An interagency working
group will conduct the survey and
collect and update the NAFDS as
directed by FSMA, including
developing metrics and measuring
progress for the evaluation process.
The survey of Federal and State
partners will be used to determine what
food defense activities, if any, Federal
and/or SLTT agencies have completed
(or are planning on completing) from
2024 to 2028. Planning for the local,
territorial, and tribal information
collections will commence during this
period of renewal. The survey will
continue to be repeated approximately
every 2 to 4 years, as described in
section 108 of FSMA. The NAFDS
survey is being administered for the
purpose of monitoring progress in food
and agricultural defense by government
agencies.
A purposive sampling strategy is
employed, such that the government
agencies participating in food and
agricultural defense are asked to
respond to the voluntary survey. Food
defense leaders responsible for
conducting food defense activities
during a food emergency for their
jurisdiction are identified and will
receive an emailed invitation to
complete the survey online; they will be
provided with a web link to the survey.
The survey will be conducted
electronically on the FDA.gov web
portal, and results will be analyzed by
the interagency working group.
Description of Respondents:
Respondents to this collection are SLTT
government representatives (survey
respondents) who are food defense
leaders responsible for conducting food
defense activities during a food
emergency for their jurisdictions.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
SLTT Surveys ............................................................................................
500
1
500
0.33 (20 minutes) .....
165
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The FDA Office of Partnerships
reviewed the questionnaire and
provided the estimate of time to
complete the survey. The total burden is
based on our previous experiences
conducting surveys. Based on a review
of the information collection since our
last request for OMB approval, we have
made no adjustments to our burden
estimate.
Food and Drug Administration
[Docket No. FDA–2024–N–1056]
[FR Doc. 2024–06316 Filed 3–25–24; 8:45 am]
Clovis Oncology, Inc., AstraZeneca
Pharmaceuticals LP, and
GlaxoSmithKline LLC; Withdrawal of
Approval of the Indications for
Advanced Ovarian Cancer for Poly
(ADP-Ribose) Polymerase Inhibitors
RUBRACA (Rucaparib) Tablets,
LYNPARZA (Olaparib) Tablets, and
ZEJULA (Niraparib) Capsules
BILLING CODE 4164–01–P
AGENCY:
Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
ddrumheller on DSK120RN23PROD with NOTICES1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that it is withdrawing
approval of the indications for the
treatment of adult patients with
SUMMARY:
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advanced ovarian cancer for poly (ADPribose) polymerase (PARP) inhibitors
under three new drug applications
(NDAs) from multiple applicants. The
applicants Clovis Oncology, Inc.
(Clovis), AstraZeneca Pharmaceuticals
LP (AZ), and GlaxoSmithKline, LLC
(GSK) have each voluntarily requested
that the Agency withdraw approval of
the indications for the treatment of adult
patients with advanced ovarian cancer
for their respective PARP inhibitors and
waived their opportunities for hearings.
Applicant and indication details are
further discussed in SUPPLEMENTARY
INFORMATION.
DATES: Approval is withdrawn as of
March 26, 2024.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
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]]>Agencies
[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Pages 20980-20982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06316]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0846]
Agency Information Collection Activities; Proposed Collection;
Comment Request; National Agriculture and Food Defense Strategy Survey
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 for
a voluntary
[[Page 20981]]
survey for the Department of Health and Human Services (HHS), the U.S.
Department of Agriculture (USDA), and the Department of Homeland
Security (DHS), which will inform the FDA Food Safety Modernization Act
(FSMA), National Agriculture and Food Defense Strategy (NAFDS) Report
to Congress. The proposed survey will be used to determine what food
defense activities, if any, State, local, territorial, and/or tribal
(SLTT) agencies have completed to date. The information will be
compared to the initial baseline data previously collected by State(s).
DATES: Either electronic or written comments on the collection of
information must be submitted by May 28, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 28, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-0846 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; National Agriculture and Food
Defense Strategy Survey.'' 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St, North Bethesda, MD 20852, 301-796-3794,
[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.
National Agriculture and Food Defense Strategy Survey
OMB Control Number 0910-0855--Extension
We are seeking OMB approval of the NAFDS under section 108 of FSMA.
This is a voluntary survey of SLTT governments intended to gauge
government activities in food and agriculture defense from intentional
contamination and emerging threats. The collected information will be
included in the mandatory NAFDS
[[Page 20982]]
followup Report to Congress. The authority for us to collect the
information derives from the Commissioner of Food and Drugs' authority
provided in section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 393(d)(2)(C)).
Protecting the nation's food and agriculture supply against
intentional contamination and other emerging threats is an important
responsibility shared by SLTT governments as well as private sector
partners. FSMA focuses on ensuring the safety of the U.S. food supply
by shifting the efforts of Federal regulators from response to
prevention and recognizes the importance of strengthening existing
collaboration among all stakeholders to achieve common public health
and security goals. FSMA identifies some key priorities for working
with partners in areas such as reliance on Federal, State, and local
agencies for inspections; improving foodborne illness surveillance; and
leveraging and enhancing State and local food safety and defense
capacities. Section 108 of FSMA-NAFDS requires HHS and USDA, in
coordination with DHS, to work together with SLTT to monitor and
measure progress in food defense.
In 2015, the initial NAFDS Report to Congress detailed the specific
Federal response to food and agriculture defense goals, objectives, key
initiatives, and activities that HHS, USDA, DHS, and other stakeholders
planned to accomplish to meet the objectives outlined in FSMA. The
NAFDS charts a direction for how Federal agencies, in cooperation with
SLTT governments and private sector partners, protect the nation's food
supply against intentional contamination. Not later than 4 years after
the initial NAFDS Report to Congress (2015), and every 4 years
thereafter (i.e., 2019, 2023, 2027, etc.), HHS, USDA, and DHS are
required to revise and submit an updated report to the relevant
committees of Congress.
FDA is the agency primarily responsible for obtaining the
information from Federal and SLTT partners to complete the NAFDS Report
to Congress. An interagency working group will conduct the survey and
collect and update the NAFDS as directed by FSMA, including developing
metrics and measuring progress for the evaluation process.
The survey of Federal and State partners will be used to determine
what food defense activities, if any, Federal and/or SLTT agencies have
completed (or are planning on completing) from 2024 to 2028. Planning
for the local, territorial, and tribal information collections will
commence during this period of renewal. The survey will continue to be
repeated approximately every 2 to 4 years, as described in section 108
of FSMA. The NAFDS survey is being administered for the purpose of
monitoring progress in food and agricultural defense by government
agencies.
A purposive sampling strategy is employed, such that the government
agencies participating in food and agricultural defense are asked to
respond to the voluntary survey. Food defense leaders responsible for
conducting food defense activities during a food emergency for their
jurisdiction are identified and will receive an emailed invitation to
complete the survey online; they will be provided with a web link to
the survey. The survey will be conducted electronically on the FDA.gov
web portal, and results will be analyzed by the interagency working
group.
Description of Respondents: Respondents to this collection are SLTT
government representatives (survey respondents) who are food defense
leaders responsible for conducting food defense activities during a
food emergency for their jurisdictions.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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SLTT Surveys................................ 500 1 500 0.33 (20 minutes)..................... 165
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The FDA Office of Partnerships reviewed the questionnaire and
provided the estimate of time to complete the survey. The total burden
is based on our previous experiences conducting surveys. Based on a
review of the information collection since our last request for OMB
approval, we have made no adjustments to our burden estimate.
Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06316 Filed 3-25-24; 8:45 am]
BILLING CODE 4164-01-P
