Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation, 60153-60157 [2015-25155]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices
several confirmed deaths in the United
States. On July 17, 2015, Acetylfentanyl
was temporarily placed into Schedule I
of the CSA for 2 years upon finding that
it posed an imminent hazard to the
public safety. The Attorney General,
though, may extend this temporary
scheduling for up to 1 year.
a-Pyrrolidinovalerophenone (a-PVP
or alpha-PVP) is a synthetic cathinone
structurally and pharmacologically
similar to amphetamine, 3,4methylenedioxymethamphetamine
(MDMA); cathinone; and other related
substances. Effects reported by abusers
of synthetic cathinone substances
include euphoria; sense of well-being;
and increased sociability, energy,
empathy, alertness, and concentration
and focus. Abusers also report
experiencing unwanted effects such as
tremor, vomiting, agitation, sweating,
fever, and chest pain. Other adverse or
toxic effects that have been reported
with the abuse of synthetic cathinones
include tachycardia, hypertension,
hyperthermia, mydriasis,
rhabdomyolysis, hyponatremia,
seizures, altered mental status (e.g.,
paranoia, hallucinations, or delusions),
and even death. On March 7, 2014,
alpha-PVP was temporarily placed into
Schedule I of the CSA for 2 years upon
finding that it posed an imminent
hazard to the public safety. The
Attorney General, though, may extend
this temporary scheduling for up to 1
year.
4-Fluoroamphetamine (4–FA) is a
psychoactive substance of the
phenethylamine and substituted
amphetamine chemical classes and
produces stimulant effects. 4–FA is not
currently controlled in the United States
under the CSA.
Para-Methyl-4-methylaminorex (4,4’DMAR) is a derivative of the stimulant
drug 4-methylaminorex and has been
involved in several deaths in the United
States. 4,4’-DMAR is not currently
controlled in the United States under
the CSA.
Para-Methoxymethylamphetamine
(PMMA) is a substituted amphetamine
of the phenethylamine class, as well as
a structural analog of paramethoxyamphetamine (PMA) which
produces effects similar but not
identical to that of MDMA. PMMA is
not currently controlled in the United
States under the CSA.
2-(ethylamino)-2-(3-methoxyphenyl)cyclohexanone (Methoxetamine or
MXE) is an arylcyclohexamine and is
not currently controlled under the CSA
in the United States. At its 36th
meeting, the WHO Expert Committee on
Drug Dependence noted the
insufficiency of data regarding
VerDate Sep<11>2014
18:34 Oct 02, 2015
Jkt 238001
60153
dependence, abuse, and risks to the
public health, thereby recommending
that Methoxetamine not be placed under
international control but be kept under
international surveillance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Opportunity To Submit Domestic
Information
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Public Health
Service Guideline on Infectious
Disease Issues in Xenotransplantation
As required by section 201(d)(2)(A) of
the CSA (21 U.S.C. 811(d)(2)(A)), FDA,
on behalf of the Department of Health
and Human Services (HHS), invites
interested persons to submit comments
regarding the 10 named drugs. Any
comments received will be considered
by HHS when it prepares a scientific
and medical evaluation of these drugs.
HHS will forward a scientific and
medical evaluation of these drugs to
WHO, through the Secretary of State, for
WHO’s consideration in deciding
whether to recommend international
control/decontrol of any of these drugs.
Such control could limit, among other
things, the manufacture and distribution
(import/export) of these drugs and could
impose certain recordkeeping
requirements on them.
Although FDA is, through this notice,
requesting comments from interested
persons which will be considered by
HHS when it prepares an evaluation of
these drugs, HHS will not now make
any recommendations to WHO
regarding whether any of these drugs
should be subjected to international
controls. Instead, HHS will defer such
consideration until WHO has made
official recommendations to the
Commission on Narcotic Drugs, which
are expected to be made in early 2016.
Any HHS position regarding
international control of these drugs will
be preceded by another Federal Register
notice soliciting public comments, as
required by section 201(d)(2)(B) of the
CSA.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25201 Filed 10–2–15; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Food and Drug Administration
[Docket No. FDA–2012–N–0559]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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: Submit either electronic or
written comments on the collection of
information by December 4, 2015.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
E:\FR\FM\05OCN1.SGM
05OCN1
60154
Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2012–N–0559 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Public
Health Service Guideline on Infectious
Disease Issues in Xenotransplantation.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• 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 Division of Dockets
Management. 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
VerDate Sep<11>2014
18:34 Oct 02, 2015
Jkt 238001
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Under the
PRA (44 U.S.C. 3501–3520), 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: (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.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
PHS Guideline on Infectious Disease
Issues in Xenotransplantation
OMB Control Number 0910–0456—
Extension
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. 301 et
seq.). 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 crossreferenced 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 (section 3.2.7.1); (2)
aliquots of serum samples from
randomly selected animal and specific
E:\FR\FM\05OCN1.SGM
05OCN1
Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices
disease investigations (section 3.4.3.1);
(3) source animal biological specimens
designated for PHS use (section 3.7.1);
animal health records (section 3.7.2),
including necropsy results (section
3.6.4); and (4) recipients’ biological
specimens (section 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 reversetranscribed 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 nosocomial exposures.
Respondents to this collection of
information are the sponsors of clinical
60155
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 three respondents who are
sponsors of 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 four source
animal facilities which provide source
xenotransplantation product material to
sponsors for use in human
xenotransplantation procedures. These
four source animal facilities keep
medical records of the herds/colonies as
well as the medical records of the
individual source animal(s). 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 thirdparty disclosure recommendations in
the PHS guideline:
TABLE 1—REPORTING RECOMMENDATIONS
PHS guideline Section
3.2.7.2 .................................
Description
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 ....................................
4.3 .......................................
Establish records linking each xenotransplantation product recipient with relevant records.
Sponsor to maintain cross-referenced system that links all relevant records (recipient, product, source animal, animal procurement center, and nosocomial exposures).
Document results of monitoring program used to detect introduction of infectious agents which may not be apparent clinically.
Document full necropsy investigations including evaluation for infectious etiologies.
Justify shortening a source animal’s quarantine period of 3 weeks prior to xenotransplantation product procurement.
Document absence of infectious agent in xenotransplantation product if its presence elsewhere in source animal
does not preclude using it.
Add summary of individual source animal record to permanent medical record of the xenotransplantation product
recipient.
Document complete necropsy results on source animals (50-year record retention).
Link xenotransplantation product recipients to individual source animal records and archived biologic specimens.
Record baseline sera of xenotransplantation health care workers and specific nosocomial exposure.
Keep a log of health care workers’ significant nosocomial exposure(s).
Document each xenotransplant procedure.
Document location and nature of archived PHS specimens in health care records of xenotransplantation product
recipient and source animal.
3.4.2 ....................................
3.4.3.2 .................................
3.5.1 ....................................
3.5.2 ....................................
3.5.4 ....................................
3.6.4 ....................................
3.7 .......................................
4.2.3.2 .................................
4.2.3.3 and 4.3.2 ................
4.3.1 ....................................
5.2 .......................................
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 3—DISCLOSURE RECOMMENDATIONS
PHS Guideline Section
Description
3.2.7.2 .................................
3.4 .......................................
3.5.1 ....................................
3.5.4 ....................................
3.5.5 ....................................
Notify sponsor or FDA of new archive site when the source animal facility or sponsor ceases operations.
Standard operating procedures (SOPs) of source animal facility should be available to review bodies.
Include increased infectious risk in informed consent if source animal quarantine period of 3 weeks is shortened.
Sponsor to make linked records described in section 3.2.7 available for review.
Source animal facility to notify clinical center when infectious agent is identified in source animal or herd after
xenotransplantation product procurement.
VerDate Sep<11>2014
18:34 Oct 02, 2015
Jkt 238001
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
E:\FR\FM\05OCN1.SGM
05OCN1
60156
Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices
FDA estimates the burden for this
collection of information as follows:
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
PHS guideline section
3.2.7.2 2 ............................................................
1
Average
burden per
response
Total annual
responses
1
1
Total
hours
0.50 (30 minutes) ......
0.50
1 There
2 FDA
are no capital costs or operating and maintenance costs associated with this collection information.
is using 1 animal facility or sponsor for estimation purposes.
TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
records per
recordkeeper
Number of
recordkeepers
PHS guideline section
Average
burden per
recordkeeping
Total annual
records
Total
hours
3.2.7 2 ...............................................................
4.3 3 ..................................................................
3.4.2 4 ...............................................................
3.4.3.2 5 ............................................................
3.5.1 6 ...............................................................
3.5.2 6 ...............................................................
3.5.4 .................................................................
3.6.4 7 ...............................................................
3.7 7 ..................................................................
4.2.3.2 8 ............................................................
4.2.3.2 6 ............................................................
4.2.3.3 and 4.3.2 6 ............................................
4.3.1 .................................................................
5.2 9 ..................................................................
1
3
3
3
3
3
3
3
4
5
5
5
3
3
1
1
10.67
2.67
0.33
0.33
1
2.67
2
25
0.20
0.20
1
4
1
3
32
8
1
1
3
8
8
125
1
1
3
12
16 ..............................
0.75 (45 minutes) ......
0.25 (15 minutes) ......
0.25 (15 minutes) ......
0.50 (30 minutes) ......
0.25 (15 minutes) ......
0.17 (10 minutes) ......
0.25 (15 minutes) ......
0.08 (5 minutes) ........
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.25 (15 minutes) ......
0.08 (5 minutes) ........
16
2.25
8
2
0.50
0.25
0.51
2
0.64
21.25
0.17
0.17
0.75
0.96
Total ..........................................................
..........................
..........................
..........................
....................................
55.45
1 There
are no capital costs or operating and maintenance costs associated with this collection information.
one-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA is using one 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 ×
1 herd per facility × 4 facilities = 24 sentinel animals. There are approximately 8 source animals per year (see footnote 7 of this table); 24 + 8 =
32 monitoring records to document.
5 Necropsy for animal deaths of unknown cause estimated to be approximately 2 per year × 1 herd per facility × 4 facilities = 8.
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 recipients × 4 annually = 8 source animals per year. (See footnote 5 of table 6.)
8 FDA estimates ther are 5 clinical centers doing xenotransplantation procedures × approximately 25 health care workers involved per center =
125 health care workers.
9 Eight source animal records + 4 recipient records = 12 total records.
2A
TABLE 6—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of
disclosures
per
respondent
Number of
respondents
PHS guideline section
Total annual
disclosures
Average burden per
disclosure
3.2.7.2 2 ....................................................................
3.4 3 ..........................................................................
3.5.1 4 .......................................................................
3.5.4 5 .......................................................................
3.5.5 4 .......................................................................
1
4
4
4
4
1
0.25
0.25
1
0.25
1
1
1
4
1
Total ..................................................................
........................
........................
........................
0.50
0.08
0.25
0.50
0.25
Total hours
(30 minutes) ......
(5 minutes) ........
(15 minutes) ......
(30 minutes) ......
(15 minutes) ......
0.50
0.08
0.25
2
0.25
....................................
3.08
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
is using one animal facility or sponsor for estimation purposes.
3 FDA’s records indicate that an average of 1 IND is 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
2 FDA
Because of the potential risk for crossspecies transmission of pathogenic
persistent virus, the guideline
recommends that health records be
retained for 50 years. Since these
VerDate Sep<11>2014
18:34 Oct 02, 2015
Jkt 238001
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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
E:\FR\FM\05OCN1.SGM
05OCN1
60157
Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices
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, FDA identifies those
collections of information activities that
are already 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
PHS guideline section
2.2.1 ....................................
2.5 .......................................
3.1.1 and 3.1.6 ....................
3.1.8 ....................................
Document offsite collaborations ....................................................................
Sponsor ensures counseling patient + family + contacts .............................
Document well-characterized health history and lineage of source animals
Registration with and import permit from the Centers for Disease Control
and Prevention.
Document collaboration with accredited microbiology labs ..........................
Procedures to ensure the humane care of animals ......................................
21 CFR Section
(unless otherwise stated)
Description of collection of information activity
3.2.2 ....................................
3.2.3 ....................................
3.2.4 ....................................
3.2.5, 3.4, and 3.4.1 ............
3.2.6 ....................................
3.3.3 ....................................
3.6.1 ....................................
3.6.2 ....................................
3.6.4 ....................................
3.7.1 ....................................
4.1.1 ....................................
4.1.2 ....................................
4.1.2.2 .................................
4.1.2.3 .................................
4.2.2.1 .................................
4.2.3.1 .................................
4.3 .......................................
Procedures consistent for accreditation by the Association for Assessment
and Accreditation of Laboratory Animal Care International (AAALAC
International) and consistent with the National Research Council’s
(NRC) Guide.
Herd health maintenance and surveillance to be documented, available,
and in accordance with documented procedures; record standard veterinary care.
Animal facility SOPs ......................................................................................
Validate assay methods ................................................................................
Procurement and processing of xenografts using documented aseptic conditions.
Develop, implement, and enforce SOP’s for procurement and screening
processes.
Communicate to FDA animal necropsy findings pertinent to health of recipient.
PHS specimens to be linked to health records; provide to FDA justification
for types of tissues, cells, and plasma, and quantities of plasma and leukocytes collected.
Surveillance of xenotransplant recipient; sponsor ensures documentation
of surveillance program life-long (justify >2 yrs.); investigator case histories (2 yrs. after investigation is discontinued).
Sponsor to justify amount and type of reserve samples ...............................
System for prompt retrieval of PHS specimens and linkage to medical
records (recipient and source animal).
Notify FDA of a clinical episode potentially representing a xenogeneic infection.
Document collaborations (transfer of obligation) ...........................................
Develop educational materials (sponsor provides investigators with information needed to conduct investigation properly).
Sponsor to keep records of receipt, shipment, and disposition of investigative drug; investigator to keep records of case histories.
312.52.
312.62(c).
312.23(a)(7)(a) and 211.84.
42 CFR 71.53.
312.52.
9 CFR parts 1, 2, and 3 and PHS
Policy.1
AAALAC International Rules of Accreditation 2 and NRC Guide.3
211.100 and 211.122.
PHS Policy.1
211.160(a).
211.100 and 211.122.
211.84(d) and 211.122(c).
312.32(c).
312.23(a)(6).
312.23(a)(6)(iii)(f) and
312.62(b) and (c).
(g),
and
211.122.
312.57(a).
312.32.
312.52.
312.50.
312.57 and 312.62(b).
mstockstill on DSK4VPTVN1PROD with NOTICES
1 The ‘‘Public Health Service Policy on Humane Care and Use of Laboratory Animals’’ (https://www.grants.nih.gov/grants/olaw/references/
phspol.htm).
2 AAALAC International Rules of Accreditation (https://www.aaalac.org/accreditation/rules.cfm).
3 The NRC’s ‘‘Guide for the Care and Use of Laboratory Animals.’’
Dated: September 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25155 Filed 10–2–15; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:34 Oct 02, 2015
Jkt 238001
PO 00000
Frm 00044
Fmt 4703
Sfmt 9990
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)]
[Notices]
[Pages 60153-60157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25155]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0559]
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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: Submit either electronic or written comments on the collection
of information by December 4, 2015.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the
[[Page 60154]]
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2012-N-0559 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Public Health Service Guideline
on Infectious Disease Issues in Xenotransplantation.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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: (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
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. 301 et seq.). 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
(section 3.2.7.1); (2) aliquots of serum samples from randomly selected
animal and specific
[[Page 60155]]
disease investigations (section 3.4.3.1); (3) source animal biological
specimens designated for PHS use (section 3.7.1); animal health records
(section 3.7.2), including necropsy results (section 3.6.4); and (4)
recipients' biological specimens (section 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 nosocomial exposures.
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 three respondents who are sponsors of 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 four source animal
facilities which provide source xenotransplantation product material to
sponsors for use in human xenotransplantation procedures. These four
source animal facilities keep medical records of the herds/colonies as
well as the medical records of the individual source animal(s). 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 PHS 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.
------------------------------------------------------------------------
[[Page 60156]]
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 per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3.2.7.2 \2\............................... 1 1 1 0.50 (30 minutes)....................... 0.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection information.
\2\ FDA is using 1 animal facility or sponsor for estimation purposes.
Table 5--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
PHS guideline section Number of records per Total annual per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
3.2.7 \2\............................ 1 1 1 16 16
4.3 \3\.............................. 3 1 3 0.75 (45 2.25
minutes)
3.4.2 \4\............................ 3 10.67 32 0.25 (15 8
minutes)
3.4.3.2 \5\.......................... 3 2.67 8 0.25 (15 2
minutes)
3.5.1 \6\............................ 3 0.33 1 0.50 (30 0.50
minutes)
3.5.2 \6\............................ 3 0.33 1 0.25 (15 0.25
minutes)
3.5.4................................ 3 1 3 0.17 (10 0.51
minutes)
3.6.4 \7\............................ 3 2.67 8 0.25 (15 2
minutes)
3.7 \7\.............................. 4 2 8 0.08 (5 0.64
minutes)
4.2.3.2 \8\.......................... 5 25 125 0.17 (10 21.25
minutes)
4.2.3.2 \6\.......................... 5 0.20 1 0.17 (10 0.17
minutes)
4.2.3.3 and 4.3.2 \6\................ 5 0.20 1 0.17 (10 0.17
minutes)
4.3.1................................ 3 1 3 0.25 (15 0.75
minutes)
5.2 \9\.............................. 3 4 12 0.08 (5 0.96
minutes)
--------------------------------------------------------------------------
Total............................ ............... ............... ............... ............... 55.45
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection information.
\2\ A one-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA is
using one 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 1 herd per facility x 4 facilities = 24 sentinel animals. There
are approximately 8 source animals per year (see footnote 7 of this table); 24 + 8 = 32 monitoring records to
document.
\5\ Necropsy for animal deaths of unknown cause estimated to be approximately 2 per year x 1 herd per facility x
4 facilities = 8.
\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 recipients x 4 annually = 8 source animals per
year. (See footnote 5 of table 6.)
\8\ FDA estimates ther 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual
PHS guideline section respondents per disclosures Average burden per disclosure Total hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
3.2.7.2 \2\................................. 1 1 1 0.50 (30 minutes)......................... 0.50
3.4 \3\..................................... 4 0.25 1 0.08 (5 minutes).......................... 0.08
3.5.1 \4\................................... 4 0.25 1 0.25 (15 minutes)......................... 0.25
3.5.4 \5\................................... 4 1 4 0.50 (30 minutes)......................... 2
3.5.5 \4\................................... 4 0.25 1 0.25 (15 minutes)......................... 0.25
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 3.08
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ FDA is using one animal facility or sponsor for estimation purposes.
\3\ FDA's records indicate that an average of 1 IND is 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
[[Page 60157]]
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, FDA identifies those collections of information
activities that are already 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 offsite 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 and 211.84.
health history and
lineage of source
animals.
3.1.8............................ Registration with 42 CFR 71.53.
and 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 AAALAC
consistent for International
accreditation by Rules of
the Association for Accreditation
Assessment and \2\ and NRC
Accreditation of Guide.\3\
Laboratory Animal
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)(ii
xenotransplant i)(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'' (https://www.grants.nih.gov/grants/olaw/references/phspol.htm).
\2\ AAALAC International Rules of Accreditation (https://www.aaalac.org/accreditation/rules.cfm).
\3\ The NRC's ``Guide for the Care and Use of Laboratory Animals.''
Dated: September 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25155 Filed 10-2-15; 8:45 am]
BILLING CODE 4164-01-P
