Notice2025-07568
Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
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Published
May 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled "PHS Guideline on Infectious Disease Issues in Xenotransplantation" dated January 19, 2001.
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<title>Federal Register, Volume 90 Issue 83 (Thursday, May 1, 2025)</title>
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[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18669-18673]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07568]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0383]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Public Health Service Guideline on Infectious Disease
Issues in Xenotransplantation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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
this notice. This notice solicits comments on the collection of
information contained in the Public Health Service (PHS) guideline
entitled ``PHS Guideline on Infectious Disease Issues in
Xenotransplantation'' dated January 19, 2001.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 30, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11.59 p.m. Eastern Time at the end of June 30, 2025. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2025-N-0383 for ``PHS Guideline on Infectious Disease Issues in
Xenotransplantation.'' 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments
[[Page 18670]]
received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket
number, found in brackets in the heading of this document, into the
``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#cb9b998a98bfaaadad8badafaae5a3a3b8e5aca4bd"><span class="__cf_email__" data-cfemail="a0f0f2e1f3d4c1c6c6e0c6c4c18ec8c8d38ec7cfd6">[email protected]</span></a>.
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.
PHS Guideline on Infectious Disease Issues in Xenotransplantation
OMB Control Number 0910-0456--Extension
This information collection helps to support Agency regulations and
guidance. The statutory authority to collect this information is
provided under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and
264) and the provisions of the Federal Food, Drug, and Cosmetic Act
that apply to drugs (21 U.S.C. 321 et seq.). In the Federal Register of
January 29, 2001 (66 FR 8120), FDA announced the availability of the
``PHS Guideline on Infectious Disease Issues in Xenotransplantation.''
The guideline, available from our website at <a href="https://www.fda.gov/media/73803/download">https://www.fda.gov/media/73803/download</a> was developed by the PHS to identify general principles
for the prevention and control of infectious diseases associated with
xenotransplantation that may pose a risk to public health. The PHS
guideline recommends procedures to diminish the risk of transmission of
infectious agents to the xenotransplantation product recipient and to
the general public. The PHS guideline is intended to address public
health issues raised by xenotransplantation, through identification of
general principles of prevention and control of infectious diseases
associated with xenotransplantation that may pose a hazard to the
public health. The collection of information described in this
guideline is intended to provide general guidance on the following
topics: (1) the development of xenotransplantation clinical protocols;
(2) the preparation of submissions to FDA; and (3) the conduct of
xenotransplantation clinical trials. Also, the collection of
information will help ensure that the sponsor maintains important
information in a cross-referenced system that links the relevant
records of the xenotransplantation product recipient,
xenotransplantation product, source animal(s), animal procurement
center, and significant nosocomial exposures. The PHS guideline
describes an occupational health service program for the protection of
health care workers involved in xenotransplantation procedures, caring
for xenotransplantation product recipients, and performing associated
laboratory testing. The PHS guideline is intended to protect the public
health and to help ensure the safety of using xenotransplantation
products in humans by preventing the introduction, transmission, and
spread of infectious diseases associated with xenotransplantation.
The PHS guideline also recommends that certain specimens and
records be maintained for 50 years beyond the date of the
xenotransplantation. These include: (1) records linking each
xenotransplantation product recipient with relevant health records of
the source animal, herd or colony, and the specific organ, tissue, or
cell type included in or used in the manufacture of the product
(3.2.7.1); (2) aliquots of serum samples from randomly selected animal
and specific disease investigations (3.4.3.1); (3) source animal
biological specimens designated for PHS use (3.7.1); animal health
records (3.7.2), including necropsy results (3.6.4); and (4)
recipients' biological specimens (4.1.2). The retention period is
intended to assist health care practitioners and officials in
surveillance and in tracking the source of an infection, disease, or
illness that might emerge in the recipient, the source animal, or the
animal herd or colony after a xenotransplantation.
The recommendation for maintaining records for 50 years is based on
clinical experience with several human viruses that have presented
problems in human to human transplantation and are therefore thought to
share certain characteristics with viruses that may pose potential
risks in xenotransplantation. These characteristics include long
latency periods and the ability to establish persistent infections.
Several also share the possibility of transmission among individuals
through intimate contact with human body fluids. Human immunodeficiency
virus (HIV) and Human T-lymphotropic virus are human retroviruses.
Retroviruses contain ribonucleic acid that is reverse-transcribed into
deoxyribonucleic acid (DNA) using an enzyme provided by the virus and
the human cell machinery. That viral DNA can then be integrated into
the human cellular DNA. Both viruses establish persistent infections
and have long latency periods before the onset of disease, 10 years and
40 to 60 years, respectively. The human hepatitis viruses are not
retroviruses, but several share with HIV the characteristic that they
can be transmitted through body fluids, can establish persistent
infections, and have long latency periods, e.g., approximately 30 years
for Hepatitis C.
In addition, the PHS guideline recommends that a record system be
developed that allows easy, accurate, and rapid linkage of information
among the specimen archive, the recipient's medical records, and the
records of the source animal for 50 years. The development of such a
record system is a one-time burden. Such a system is intended to cross-
reference and locate relevant records of recipients, products, source
animals, animal procurement centers, and significant nosocomial
exposures.
[[Page 18671]]
Respondents to this collection of information are the sponsors of
clinical studies of investigational xenotransplantation products under
investigational new drug applications (INDs) and xenotransplantation
product procurement centers, referred to as source animal facilities.
There are an estimated five respondents who are sponsors of seven INDs
that include protocols for xenotransplantation in humans and five
clinical centers doing xenotransplantation procedures. Other
respondents for this collection of information are an estimated two
source animal facilities which provide source xenotransplantation
product material to sponsors for use in human xenotransplantation
procedures. These two source animal facilities keep medical records of
the herds/colonies as well as the medical records of the individual
source animal(s). There are an estimated three herds of approximately
six animals per herd. The burden estimates are based on FDA's records
of xenotransplantation-related INDs and estimates of time required to
complete the various reporting, recordkeeping, and third-party
disclosure tasks described in the PHS guideline.
FDA is requesting an extension of OMB approval for the following
reporting, recordkeeping, and third-party disclosure recommendations in
the PHS guideline:
Table 1--Reporting Recommendations
------------------------------------------------------------------------
PHS guideline section Description
------------------------------------------------------------------------
3.2.7.2............................ Notify sponsor or FDA of new
archive site when the source
animal facility or sponsor ceases
operations.
------------------------------------------------------------------------
Table 2--Recordkeeping Recommendations
------------------------------------------------------------------------
PHS guideline section Description
------------------------------------------------------------------------
3.2.7.............................. Establish records linking each
xenotransplantation product
recipient with relevant records.
4.3................................ Sponsor to maintain cross-
referenced system that links all
relevant records (recipient,
product, source animal, animal
procurement center, and nosocomial
exposures).
3.4.2.............................. Document results of monitoring
program used to detect
introduction of infectious agents
which may not be apparent
clinically.
3.4.3.2............................ Document full necropsy
investigations including
evaluation for infectious
etiologies.
3.5.1.............................. Justify shortening a source
animal's quarantine period of 3
weeks prior to xenotransplantation
product procurement.
3.5.2.............................. Document absence of infectious
agent in xenotransplantation
product if its presence elsewhere
in source animal does not preclude
using it.
3.5.4.............................. Add summary of individual source
animal record to permanent medical
record of the xenotransplantation
product recipient.
3.6.4.............................. Document complete necropsy results
on source animals (50-year record
retention).
3.7................................ Link xenotransplantation product
recipients to individual source
animal records and archived
biologic specimens.
4.2.3.2............................ Record baseline sera of
xenotransplantation health care
workers and specific nosocomial
exposure.
4.2.3.3 and 4.3.2.................. Keep a log of health care workers'
significant nosocomial
exposure(s).
4.3.1.............................. Document each xenotransplant
procedure.
5.2................................ Document location and nature of
archived specimens in health care
records of xenotransplantation
product recipient and source
animal.
------------------------------------------------------------------------
Table 3--Disclosure Recommendations
------------------------------------------------------------------------
PHS guideline section Description
------------------------------------------------------------------------
3.2.7.2............................ Notify sponsor or FDA of new
archive site when the source
animal facility or sponsor ceases
operations.
3.4................................ Standard operating procedures
(SOPs) of source animal facility
should be available to review
bodies.
3.5.1.............................. Include increased infectious risk
in informed consent if source
animal quarantine period of 3
weeks is shortened.
3.5.4.............................. Sponsor to make linked records
described in section 3.2.7
available for review.
3.5.5.............................. Source animal facility to notify
clinical center when infectious
agent is identified in source
animal or herd after
xenotransplantation product
procurement.
------------------------------------------------------------------------
FDA estimates the burden for this collection of information as
follows:
Table 4--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
PHS guideline section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
3.2.7.2 \2\..................... 1 1 1 0.50 (30 0.50
minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ FDA is using 1 animal facility or sponsor for estimation purposes.
[[Page 18672]]
Table 5--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
PHS guideline section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
3.2.7 \2\....................... 1 1 1 16.............. 16
4.3 \3\......................... 5 1 5 0.75 (45 3.75
minutes).
3.4.2 \4\....................... 5 8.80 44 0.25 (15 11
minutes).
3.4.3.2 \5\..................... 5 2.40 12 0.25 (15 3
minutes).
3.5.1 \6\....................... 5 0.33 1 0.50 (30 0.50
minutes).
3.5.2 \6\....................... 5 0.33 1 0.25 (15 0.25
minutes).
3.5.4........................... 5 1 5 0.17 (10 0.85
minutes).
3.6.4 \7\....................... 5 1.60 8 0.25 (15 2
minutes).
3.7 \7\......................... 4 2 8 0.08 (5 minutes) 0.64
4.2.3.2 \8\..................... 4 25 100 0.17 (10 17.0
minutes).
4.2.3.2 \6\..................... 4 0.20 1 0.17 (10 0.17
minutes).
4.2.3.3 and 4.3.2 \6\........... 4 0.25 1 0.17 (10 0.17
minutes).
4.3.1........................... 5 1.40 7 0.25 (15 1.25
minutes).
5.2 \9\......................... 5 2.40 12 0.08 (5 minutes) 0.96
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Total....................... ............... ............... ............ ................ 58.04
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ A one-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA is
using 1 new sponsor for estimation purposes.
\3\ FDA estimates there is minimal recordkeeping burden associated with maintaining the record system.
\4\ Monitoring for sentinel animals (subset representative of herd) plus all source animals. There are
approximately 6 sentinel animals per herd x 3 herds per facility x 2 facilities = 36 sentinel animals. There
are approximately 8 source animals per year (see footnote 7 of this table); 36 + 8 = 44 monitoring records to
document.
\5\ Necropsy for animal deaths of unknown cause estimated to be approximately 2 per herd per year x 3 herds per
facility x 2 facilities = 12.
\6\ Has not occurred in the past 3 years and is expected to continue to be a rare occurrence.
\7\ On average 2 source animals are used for preparing xenotransplantation product material for one recipient.
The average number of source animals is 2 source animals per recipient x 4 recipients annually = 8 source
animals per year. (See footnote 5 of table 6 of this document.)
\8\ FDA estimates there are 5 clinical centers doing xenotransplantation procedures x approximately 25 health
care workers involved per center = 125 health care workers.
\9\ Eight source animal records + 4 recipient records = 12 total records.
Table 6--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
PHS guideline section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
3.2.7.2 \2\..................... 1 1 2 0.50 (30 1.00
minutes).
3.4 \3\......................... 2 0.50 1 0.08 (5 minutes) 0.08
3.5.1 \4\....................... 2 0.50 1 0.25 (15 0.25
minutes).
3.5.4 \5\....................... 2 2 4 0.50 (30 2.00
minutes).
3.5.5 \4\....................... 2 0.50 1 0.25 (15 0.25
minutes).
-------------------------------------------------------------------------------
Total....................... ............... ............... ............ ................ 3.58
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ FDA is using 1 animal facility or sponsor for estimation purposes.
\3\ FDA's records indicate that an average of 2 INDs are expected to be submitted per year.
\4\ To our knowledge, has not occurred in the past 3 years and is expected to continue to be a rare occurrence.
\5\ Based on an estimate of 12 patients treated over a 3 year period, the average number of xenotransplantation
product recipients per year is estimated to be 4.
Because of the potential risk for cross-species transmission of
pathogenic persistent virus, the guideline recommends that health
records be retained for 50 years. Since these records are medical
records, the retention of such records for up to 50 years is not
information subject to the PRA (5 CFR 1320.3(h)(5)). Also, because of
the limited number of clinical studies with small patient populations,
the number of records is expected to be insignificant at this time.
Information collections in this guideline not included in tables 1
through 6 can be found under existing regulations and approved under
the OMB control numbers as follows: (1) ``Current Good Manufacturing
Practice for Finished Pharmaceuticals,'' 21 CFR 211.1 through 211.208,
approved under OMB control number 0910-0139; (2) ``Investigational New
Drug Application,'' 21 CFR 312.1 through 312.160, approved under OMB
control number 0910-0014; and (3) information included in a biologics
license application, 21 CFR 601.2, approved under OMB control number
0910-0338. (Although it is possible that a xenotransplantation product
may not be regulated as a biological product (e.g., it may be regulated
as a medical device), FDA believes, based on its knowledge and
experience with xenotransplantation, that any xenotransplantation
product subject to FDA regulation within the next 3 years will most
likely be regulated as a biological product.) However, FDA recognized
that some of the information collections go beyond approved
collections; assessments for these burdens are included in tables 1
through 6.
In table 7 of this document, FDA identifies those collection of
information activities that are already
[[Page 18673]]
encompassed by existing regulations or are consistent with voluntary
standards which reflect industry's usual and customary business
practice.
Table 7--Collection of Information Required by Current Regulations and
Standards
------------------------------------------------------------------------
21 CFR section
Description of (unless
PHS guideline section collection of otherwise
information activity stated)
------------------------------------------------------------------------
2.2.1.......................... Document off-site 312.52.
collaborations.
2.5............................ Sponsor ensures 312.62(c).
counseling patient +
family + contacts.
3.1.1 and 3.1.6................ Document well- 312.23(a)(7)(a)
characterized health and 211.84.
history and lineage
of source animals.
3.1.8.......................... Registration with and 42 CFR 71.53.
import permit from
the Centers for
Disease Control and
Prevention.
3.2.2.......................... Document 312.52.
collaboration with
accredited
microbiology labs.
3.2.3.......................... Procedures to ensure 9 CFR parts 1,
the humane care of 2, and 3 and
animals. PHS Policy.\1\
3.2.4.......................... Procedures consistent AAALAC
for accreditation by International
the Association for Rules of
Assessment and Accreditation
Accreditation of \2\ and NRC
Laboratory Animal Guide.\3\
Care International
(AAALAC
International) and
consistent with the
National Research
Council's (NRC)
Guide.
3.2.5, 3.4, and 3.4.1.......... Herd health 211.100 and
maintenance and 211.122.
surveillance to be
documented,
available, and in
accordance with
documented
procedures; record
standard veterinary
care.
3.2.6.......................... Animal facility SOPs. PHS Policy \1\.
3.3.3.......................... Validate assay 211.160(a).
methods.
3.6.1.......................... Procurement and 211.100 and
processing of 211.122.
xenografts using
documented aseptic
conditions.
3.6.2.......................... Develop, implement, 211.84(d) and
and enforce SOP's 211.122(c).
for procurement and
screening processes.
3.6.4.......................... Communicate to FDA 312.32(c).
animal necropsy
findings pertinent
to health of
recipient.
3.7.1.......................... PHS specimens to be 312.23(a)(6).
linked to health
records; provide to
FDA justification
for types of
tissues, cells, and
plasma, and
quantities of plasma
and leukocytes
collected.
4.1.1.......................... Surveillance of 312.23(a)(6)(iii
xenotransplant )(f) and (g),
recipient; sponsor and 312.62(b)
ensures and (c).
documentation of
surveillance program
life-long (justify
>2 yrs.);
investigator case
histories (2 yrs.
after investigation
is discontinued).
4.1.2.......................... Sponsor to justify 211.122.
amount and type of
reserve samples.
4.1.2.2........................ System for prompt 312.57(a).
retrieval of PHS
specimens and
linkage to medical
records (recipient
and source animal).
4.1.2.3........................ Notify FDA of a 312.32.
clinical episode
potentially
representing a
xenogeneic infection.
4.2.2.1........................ Document 312.52.
collaborations
(transfer of
obligation).
4.2.3.1........................ Develop educational 312.50.
materials (sponsor
provides
investigators with
information needed
to conduct
investigation
properly).
4.3............................ Sponsor to keep 312.57 and
records of receipt, 312.62(b).
shipment, and
disposition of
investigative drug;
investigator to keep
records of case
histories.
------------------------------------------------------------------------
\1\ The ``Public Health Service Policy on Humane Care and Use of
Laboratory Animals'' (<a href="https://olaw.nih.gov/policies-laws/phs-policy.htm">https://olaw.nih.gov/policies-laws/phs-policy.htm</a>).
\2\ AAALAC International Rules of Accreditation (<a href="https://www.aaalac.org/accreditation-program/rules-of-accreditation/">https://www.aaalac.org/accreditation-program/rules-of-accreditation/</a>).
\3\ The NRC's ``Guide for the Care and Use of Laboratory Animals.''
Based on a review of the information collection since our last
request for OMB approval, we have adjusted our burden estimate which
has resulted in a burden increase of 3.09 hours (new total of 62.12
hours) from our previous estimate of 59.03 hours. Change in the
increase in burden was the result of the change of the number of
recordkeepers due to the change in the number submission of IND's
sponsors and a change in the number of animal source facilities.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07568 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P
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