[Federal Register Volume 81, Number 24 (Friday, February 5, 2016)]
[Notices]
[Pages 6326-6328]
[FR Doc No: 2016-02299]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2015-0336]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA confirms its decision to exempt 54 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on December 15, 2015. The
exemptions expire on December 15, 2017.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.
e.t., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On November 12, 2015, FMCSA published a notice of receipt of
Federal diabetes exemption applications from 54 individuals and
requested comments from the public (80 FR 70067). The public comment
period closed on December 14, 2015, and one comment was received.
    FMCSA has evaluated the eligibility of the 54 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 54 applicants have had ITDM over a range of 1 to 41 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the November 12, 2015, Federal
Register notice and they will not be repeated in this notice.

III. Discussion of Comments

    FMCSA received one comment in this proceeding. Latu Anitoni stated
that, in her opinion, drivers using insulin are safer due to the
monitoring the condition requires, and believes the exemptions should
be granted.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Conclusion

    Based upon its evaluation of the 54 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above 949 CFR
391.64(b)):

Ramon Becerra (IN)
Harry L. Blakely (MN)
Steven J. Bloemker (OH)
Billy J. Bookout (OK)
David M. Brady (NE)
William G. Bush (IL)
Gene D. Carey, Jr. (PA)
James C. Decker (CA)
Richard D. Doherty (MA)
Richard N. Dunn (KS)
Thomas C. Eklund (OR)
Rodney L. Forrister, Jr. (MI)
Ronald J. Gasper (SD)
Jeremy J. Giesbrecht (IN)

David F. Goehring (WI)
Robert J. Golding (ME)
Ethan T. Heideman (MN)
Benjamin R. Hickerson (CA)
Timothy J. Hrinak (PA)
Kevin M. Hunt (MI)
David T. Issler (NY)
Todd D. Jacquin (NC)
Bruce E. Kerr (KY)
Mark C. Kucharski (CO)
Philip M. LaPierre (ME)
Mary J. Martin (PA)
Peter J. Meier (WA)
Terry J. Miller (WI)
Michael E. Morel (NH)
Marvin K. Mosley (SC)
Eric Nieves, Jr. (NY)
Jerry D. Pearce (NM)
George W. Pottle, IV (ME)
Kenneth A. Prine (WA)
Charles R. Ratcliff, Jr. (VA)
Joseph B. Ribitzki (AR)
Roger D. Richey (IN)
Michael G. Sanchez (CA)
Guido J. Scarafoni (MA)
Jeffrey M. Schleisman (IA)
Scott J. Schmidt (NE)
Lori A. Shaffnit (IA)
Sanampreet Singh (CA)
Joshua A. Snyder (WV)
Christophe M. Stephens (TN)
Michael A. Stille (GA)
Leonard Tawahongva (AZ)
Edward M. Taylor (NE)
Donald L. Trogdon (ID)
Gregory S. Van Hal (MN)
Lazario R. Watkins (NC)
Eric J. Watson (NY)
William T. White (WA)
J. Ryan Wolf (IN)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: January 19, 2016.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2016-02299 Filed 2-4-16; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Notices]
[Page 24417]
[FR Doc No: 2014-09804]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-151-000]

Notice of Request Under Blanket Authorization; Pan Gas Storage,
LLC d/b/a Southwest Gas Storage Company

    Take notice that on April 14, 2014 Southwest Gas Storage Company
(Southwest), P.O. Box 4967, Houston, Texas 77210-4967, filed in the
above Docket, a prior notice request pursuant to sections 157.205,
157.208(b), 157.213(b) and 157.216(b)(2) of the Commission's
regulations under the Natural Gas Act (NGA) and Southwest's blanket
certificate issued in CP99-230-000, for authorization to construct,
modify and abandon certain natural gas storage facilities located the
Howell Storage Field in Livingston County, Michigan, all as more fully
set forth in the application which is on file with the Commission and
open to public inspection. The filing may also be viewed on the web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to
Stephen Veatch, Senior Director of Certificates, Southwest Gas Storage
Company, 1300 Main Street, Houston, Texas 77002, or call (713) 989-
2024, or fax<PHONE_NUMBER>, or by email<EMAIL_ADDRESS>    Specifically, Southwest is seeking authorization to continue
modifying Southwest's Howell Storage Field to serve the needs of the
applicant and its customers. The proposed modifications consist of
reentering and modifying two existing injection-withdrawal vertical
wells and drilling dual horizontal wellbore extensions from each
existing well; converting six existing injection-withdrawal wells to
observation well status; relaying/modifying three laterals lines; and
abandoning in place six associated storage lateral lines and
appurtenant facilities. Southwest states that the proposed
modifications will have no impact on the certified physical parameters
including total gas storage inventory, reservoir pressure, reservoirs
and buffer boundaries, and certified capacity. Southwest also states
that the estimated cost of the Project is $4,365,622 and $965,622 for
the well conversion and to abandon and or modify the storage laterals
respectively.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the Natural Gas Act (NGA) (18 CFR 157.205) file a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for protest. If a protest is filed and not
withdrawn within 30 days after the time allowed for filing a protest,
the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link.

    Dated: April 23, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-09804 Filed 4-29-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Pages 66307-66309]
[FR Doc No: 2022-23919]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0341]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Federal-State Food Regulatory Program Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 revision 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 provisions associated
with FDA's Federal-State Food Regulatory Program Standards.

DATES: Either electronic or written comments on the collection of
information must be submitted by January 3, 2023.

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 January 3, 2023. 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-2021-N-0341 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Safety; Federal-State Food
Regulatory Program Standards.'' 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,<PHONE_NUMBER>.
     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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[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 revision 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.

Federal-State Food Regulatory Program Standards

OMB Control Number 0910-0760--Revision

    This information collection supports FDA's Animal Food (formerly
``Feed'') Regulatory Program Standards (AFRPS) and Egg Regulatory
Program Standards (ERPS). In the United States, Federal and State
government agencies ensure the safety of human and animal food. FDA is
responsible for ensuring that all human and animal food moving in
interstate commerce, except those under the U.S. Department of
Agriculture jurisdiction, are safe, wholesome, and labeled properly.
States are responsible for conducting inspections and regulatory
activities that help ensure human and animal food a produced,
processed, and distributed within their jurisdictions are safe and in
compliance with State laws and regulations. States primarily perform
inspections under their own regulatory authority. Some States conduct
inspections of human and animal food facilities under contract with
FDA. Because jurisdictions may overlap, FDA and States collaborate and
share resources to protect human and animal food.
    The FDA Food Safety Modernization Act calls for enhanced
partnerships and provides a legal mandate for developing an Integrated
Food Safety System (IFSS). FDA is committed to implementing an IFSS
thereby optimizing coordination of human and animal food safety efforts
with Federal, State, local, tribal, and territorial regulatory and
public health agencies. Model standards provide a consistent,
underlying foundation that is critical for uniformity across State and
Federal agencies to ensure credibility of human and animal food
programs within the IFSS. The AFRPS and ERPS provide a uniform and
consistent approach to animal food and egg regulation in the United
States. Implementation of the AFRPS and ERPS are voluntary.
    The AFRPS and ERPS are the frameworks that each State should use to
design, manage, and improve its animal food or egg regulatory program.
The AFRPS standards include the following: (1) regulatory foundation;
(2) training program; (3) inspection program; (4) audit program; (5)
animal food-related illnesses or death and emergency response; (6)
compliance and enforcement program; (7) outreach program; (8) planning
and resources; (9) assessment and improvement; (10) laboratory
services; and (11) sampling program. The ERPS include equivalent
standards for egg regulatory programs except they do not include a
separate standard 11 sampling program. Each standard has a purpose
statement, requirement summary, description of program elements,
projected outcomes, and a list of required documentation. When a state
program voluntarily agrees to implement the standards, it must fully
implement and maintain the individual program elements and
documentation requirements in each standard in order to fully implement
the standard. We invite you to visit our website (https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives/regulatory-program-standards) for more information and to access the program
standards.
    Both the AFRPS and ERPS package include forms, worksheets, and
templates to help the State program assess and meet the program
elements in the standard. State programs are not obligated to use the
forms, worksheets, and templates. Other manual or automated forms,
worksheets, and templates may be used as long as the pertinent data
elements are present. Records and other documents specified in the
AFRPS and ERPS must be maintained in good order by the state program
and must be available to verify the implementation of each standard.
    As set forth in the AFRPS and ERPS, the state program is expected
to review and update its improvement plan on an annual basis. The state
program completes an evaluation of its implementation status at least
every 3 years following the baseline evaluation by reviewing and
updating the self-assessment worksheets and required documentation for
each standard. The evaluation is needed to determine if each standard's
requirements are, or remain, fully met, partially met, or not met. The
state program revises the improvement plan based upon this evaluation.
    In collaboration with the State Governments, FDA recently completed
a revision of the animal food program standards that incorporated the
most current knowledge and lessons learned in the application of the
2020 AFRPS by State partners and program assessment by FDA. In an
effort to improve program effectiveness, understanding and clarity,
changes to the AFRPS include those to program definitions, all 11
program standards, appendices and assessment worksheets that may be
used by the States who have adopted the AFRPS. Such changes include
updates to terminology, most notably replacing the term ``animal feed''
with ``animal food'' consistent with the terminology of the FDA Food
Safety Modernization Act, and minor editorial changes. Other changes
include streamlining both the standards and appendices to be less
prescriptive in nature and better focus on information capture needs.
This process results in an overall reduction of 11 appendices (most of
which provided more program specific guidance or examples and therefore
are not expected to change the burden) and a reformatting of the
remaining

appendices to be more uniform, succinct and tabular in structure. The
revised program standards are the result of external collaboration and
coordination between FDA and the Association of American Feed Control
Officials (AAFCO) in which we consider any formal comments received on
the 2020 edition of the program standards and feedback obtained from
our collaboration with the States. A copy of the revised program
standards is available in the docket.
    Description of Respondents: Respondents are State Departments of
Agriculture or Health enrolled in the AFRPS or ERPS (State
Governments).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
  Type of respondents; activity      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
State, local, Territorial, and/               25               1              25             569          14,225
 or Tribal Governments;
 submission of data elements to
 FDA consistent with AFRPS......
State, local, Territorial and/or              10               1              10             569           5,690
 Tribal Governments; submission
 of data elements to FDA
 consistent with ERPS...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          19,915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
  Type of respondents; activity      Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
State, local, Territorial, and/               25              11             275              40          11,000
 or Tribal Governments;
 submission of data elements to
 FDA consistent with AFRPS......
State, local, Territorial and/or              10              10             100              40           4,000
 Tribal Governments; submission
 of data elements to FDA
 consistent with ERPS...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          15,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    No change in burden is expected to be incurred with the
implementation of the revised AFRPS. However, we have adjusted the
number of respondents to the information collection associated with the
AFRPS to reflect a reduction in enrollment since our last evaluation.
In addition, based on the Agency's experience over the past 3 years, we
have added reporting burden and adjusted the recordkeeping burden
estimates associated with the AFRPS and ERPS, resulting in an increase
in responses and burden hours.

    Dated: October 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23919 Filed 11-2-22; 8:45 am]
BILLING CODE 4164-01-P