24316 Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 

II. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

1. Aikin, K.J., K.R. Betts, K.S. Ziemer, et al. 

(2019). ‘‘Consumer Tradeoff of 

Advertising Claim Versus Efficacy 

Information in Direct-to-Consumer 

Prescription Drug Ads.’’ Research in 

Social and Administrative Pharmacy, 

15(12), 1484–1488. https://doi.org/ 

10.1016/j.sapharm.2019.01.012. 

*2. Arroyo, R., A.P. Sempere, E. Ruiz-Beato, 

et al. (2017). ‘‘Conjoint Analysis to 

Understand Preferences of Patients With 

Multiple Sclerosis for Disease-Modifying 

Therapy Attributes in Spain: A CrossSectional Observational Study.’’ BMJ 

Open, 7(3), e014433. https://doi.org/ 

10.1136/bmjopen-2016-014433. 

3. Fraenkel, L., L. Suter, C.E. Cunningham, et 

al, (2014). ‘‘Understanding Preferences 

for Disease-Modifying Drugs in 

Osteoarthritis.’’ Arthritis Care & 

Research, 66(8), 1186–1192. https://

pubmed.ncbi.nlm.nih.gov/24470354/. 

4. Katz, D.A., C. Hamlin, M.W. Vander Weg, 

et al. (2020). ‘‘Veterans’ Preferences for 

Tobacco Treatment in Primary Care: A 

Discrete Choice Experiment.’’ Patient 

Education and Counseling, 103(3), 652– 

660. https://doi.org/10.1016/ 

j.pec.2019.10.002. 

5. Wouters, H., G.A. Maatman, L. Van Dijk, 

et al. (2013). ‘‘Trade-Off Preferences 

Regarding Adjuvant Endocrine Therapy 

Among Women With Estrogen ReceptorPositive Breast Cancer.’’ Annals of 

Oncology, 24(9), 2324–2329. https://

doi.org/10.1093/annonc/mdt195. 

6. Gregorian, Jr., R.S., A. Gasik, W.J. Kwong, 

et al. (2010). ‘‘Importance of Side Effects 

in Opioid Treatment: A Trade-Off 

Analysis With Patients and Physicians.’’ 

The Journal of Pain, 11(11), 1095–1108. 

https://doi.org/10.1016/ 

j.jpain.2010.02.007. 

7. Johnson, FR, E. Lancsar, D. Marshall, et al. 

(2013). ‘‘Constructing Experimental 

Designs for Discrete-Choice Experiments: 

Report of the ISPOR Conjoint Analysis 

Experimental Design Good Research 

Practices Task Force.’’ Value in Health, 

16(1), 3–13. https://doi.org/10.1016/ 

j.jval.2012.08.2223. 

8. Bridges, J.F.P., A.B. Hauber, D. Marshall, 

et al. (2011). ‘‘Conjoint Analysis 

Applications in Health—A Checklist: A 

Report of the ISPOR Good Research 

Practices for Conjoint Analysis Task 

Force.’’ Value in Health, 14(4), 403–413. 

https://doi.org/10.1016/ 

j.jval.2010.11.013. 

9. Orme, B. (2019). Getting Started With 

Conjoint Analysis: Strategies for Product 

Design and Pricing Research (Fourth 

ed.). Madison, WI: Research Publishers 

LLC. 

10. Johnson, F., B. Kanninen, M. Bingham, et 

al. (2006). ‘‘Experimental Design for 

Stated-Choice Studies.’’ In: Valuing 

Environmental Amenities Using Stated 

Choice Studies (pp. 159–202). B.J. 

Kanninen (Ed.). Dordrecht: Springer. 

Dated: April 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08728 Filed 4–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0559] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Public Health 

Service Guideline on Infectious 

Disease Issues in Xenotransplantation 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by May 25, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0456. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Public Health Service (PHS) Guideline 

on Infectious Disease Issues in 

Xenotransplantation 

OMB Control Number 0910–0456— 

Extension 

This information collection helps 

support implementation of the 

Department of Health and Human 

Services’ ‘‘PHS Guideline on Infectious 

Disease Issues in Xenotransplantation’’ 

dated January 19, 2001, available at: 

https://www.fda.gov/media/73803/ 

download. FDA is authorized to collect 

this information under sections 351 and 

361 of the PHS Act (42 U.S.C. 262 and 

264) and provisions of the Federal Food, 

Drug, and Cosmetic Act that apply to 

drugs (21 U.S.C. 321 et seq.). The 

guideline 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 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 also describes an occupational 

health service program for the 

protection of health care workers 

involved in xenotransplantation 


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Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 24317 

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); (4) animal health 

records (3.7.2), including necropsy 

results (3.6.4); and (5) 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, 

such as human cytomegalovirus and BK 

polyoma virus, which 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 significant 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. 

In the Federal Register of October 22, 

2021 (86 FR 58666), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment letter, which contained 

multiple comments, in response to the 

notice. Several comments 

(recommendations for selection of 

xenograft recipients, hospital personnel 

and care providers, and handling of 

donor and recipient tissue) were not 

responsive to the four information 

collection topics solicited in the 60-day 

notice and therefore will not be 

addressed in this notice. 

(Comment 1) One comment in the 

letter was supportive of expanded 

collection and testing of blood samples 

from xenograft recipients, their 

immediate family, close social/sexual 

contacts, as well as other persons at risk 

of exposure to infection. 

(Response) We agree with the utility 

of blood sampling and testing to track 

the source of any long-term developing 

infections as a result of 

xenotransplantation. We have 

considered the comment and have 

determined that the comment does not 

present information that would warrant 

substantive changes to the guideline at 

this time. 

(Comment 2) One comment in the 

letter recommended shortening the 50- 

year retention period for frozen samples 

of serum, cells, and tissues 

recommended by the PHS guideline. 

Among other reasons, the comment 

argued that transplant recipients 

generally manifest either donor-derived 

or opportunistic infections in the firstyear post-transplantation; malignancies 

and uncommon infections may manifest 

later, but generally within 5–10 years; 

and patient survival post-organ 

transplantation is generally less than 20 

years. The comment concluded that 

storage of samples beyond 20 years for 

initial studies should not be necessary. 

(Response) We have considered the 

comment and have determined that the 

comment does not present information 

that would warrant substantive changes 

to the guideline at this time. 

(Comment 3) One comment in the 

letter stated that the sponsor of the 

clinical trial or the hospital in which the 

trial is carried out should be relieved of 

the responsibility to store their records 

and samples. The comment argued that 

ongoing data and specimen collection, 

as well as the maintenance of 

repositories represents a significant 

burden on both sponsors and transplant 

programs with resultant significant cost 

and hardship that could deter 

xenotransplant progress. The comment 

concluded that storage of records and 

samples should be the responsibility of 

a recognized government authority or 

institution or an FDA-designated 

organization. The comment 

recommended the creation of a central 

repository for both data and specimen 

collection run by, or under contract 

with, the Federal government. 

(Response) The comment did not 

provide any data that would support a 

change to the burden estimate in the 60- 

day notice. Thus, FDA has not changed 

the burden estimate in table 1 of this 

document. We have considered the 

comment and have determined that the 

comment does not present information 

that would warrant substantive changes 

to the guideline at this time. 

FDA is requesting an extension of 

OMB approval for the following 

reporting, recordkeeping and third-party 


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24318 Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 

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 of this 

collection of information as follows: 

TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1

PHS guideline section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

3.2.7.2 2 ................................................ 1 1 1 0.5 (30 minutes) ..... 0.5 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2FDA is using one animal facility or sponsor for estimation purposes. 

TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

PHS guideline section Number of 

recordkeepers 

Number of records 

per recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

3.2.7 2 ................................................... 1 1 1 16 ........................... 16 

4.3 3 ...................................................... 3 1 3 0.75 (45 minutes) ... 2.25 

3.4.2 4 ................................................... 3 10.67 32 0.25 (15 minutes) .. 8 

3.4.3.2 5 ................................................ 3 2.67 8 0.25 (15 minutes) ... 2 

3.5.1 6 ................................................... 3 0.33 1 0.5 (30 minutes) ..... 0.50 

3.5.2 6 ................................................... 3 0.33 1 0.25 (15 minutes) .. 0.25 

3.5.4 ..................................................... 3 1 3 0.17 (10 minutes) .. 0.51 

3.6.4 7 ................................................... 3 2.67 8 0.25 (15 minutes) .. 2 

3.7 7 ...................................................... 4 2 8 0.08 (5 minutes) ..... 0.64 


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I I 
Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 24319 

TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

PHS guideline section Number of 

recordkeepers 

Number of records 

per recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

4.2.3.2 8 ................................................ 5 25 125 0.17 (10 minutes) .. 21.25 

4.2.3.2 6 ................................................ 5 0.2 1 0.17 (10 minutes) ... 0.17 

4.2.3.3 and 4.3.2 6 ............................... 5 0.2 1 0.17 (10 minutes) ... 0.17 

4.3.1 ..................................................... 3 1 3 0.25 (15 minutes) .. 0.75 

5.2 9 ...................................................... 3 4 12 0.08 (5 minutes) ..... 0.96 

Total .............................................. .............................. .............................. .............................. ................................ 55.45 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2A 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. 3FDA 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 herd 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. 

7On average two source animals are used for preparing xenotransplantation product material for one recipient. The average number of source 

animals is 2 source animals per recipient × 4 recipients annually = 8 source animals per year. (See footnote 5 of table 6.) 8FDA estimates there are 5 clinical centers doing xenotransplantation procedures × approximately 25 health care workers involved per center 

= 125 health care workers. 9Eight source animal records + 4 recipient records = 12 total records. 

TABLE 6—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

PHS guideline section Number of respondents 

Number of disclosures per respondent 

Total annual disclosures Average burden per 

disclosure Total hours 

3.2.7.2 2 ................................................ 1 1 1 0.5 (30 minutes) ..... 0.5 

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 0.5 (30 minutes) ..... 2 

3.5.5 4 ................................................... 4 0.25 1 0.25 (15 minutes) .. 0.25 

Total .............................................. .............................. .............................. .............................. ................................ 3.08 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2FDA is using one animal facility or sponsor for estimation purposes. 

3FDA’s records indicate that an average of one IND is expected to be submitted per year. 

4To our knowledge, has not occurred in the past 3 years and is expected to continue to be a rare occurrence. 

5Based 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 crossspecies 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, FDA identifies those 

collection 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 Description 21 CFR section 

(unless otherwise stated) 

2.2.1 .............................. Document offsite collaborations ............................................................ 312.52. 

2.5 ................................. Sponsor ensures counseling patient + family + contacts ..................... 312.62(c). 


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24320 Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 

TABLE 7—COLLECTION OF INFORMATION REQUIRED BY CURRENT REGULATIONS AND STANDARDS—Continued 

PHS guideline section Description 21 CFR section 

(unless otherwise stated) 

3.1.1 and 3.1.6 .............. Document well-characterized health history and lineage of source 

animals..

312.23(a)(7)(a) and 211.84. 

3.1.8 .............................. Registration with and import permit from the Centers for Disease 

Control and Prevention..

42 CFR 71.53. 

3.2.2 .............................. Document collaboration with accredited microbiology labs .................. 312.52. 

3.2.3 .............................. Procedures to ensure the humane care of animals ............................. 9 CFR parts 1, 2, and 3 and PHS Policy 1. 

3.2.4 .............................. 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.

AAALAC International Rules of Accreditation 2

and NRC Guide 3. 

3.2.5, 3.4, and 3.4.1 ...... Herd health maintenance and surveillance to be documented, available, and in accordance with documented procedures; record 

standard veterinary care.

211.100 and 211.122. 

3.2.6 .............................. Animal facility SOPs .............................................................................. PHS Policy 1. 

3.3.3 .............................. Validate assay methods ........................................................................ 211.160(a). 

3.6.1 .............................. Procurement and processing of xenografts using documented aseptic 

conditions.

211.100 and 211.122. 

3.6.2 .............................. Develop, implement, and enforce SOPs for procurement and screening processes.211.84(d) and 211.122(c). 

3.6.4 .............................. Communicate to FDA animal necropsy findings pertinent to health of 

recipient.

312.32(c). 

3.7.1 .............................. 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.

312.23(a)(6). 

4.1.1 .............................. Surveillance of xenotransplant recipient; sponsor ensures documentation of surveillance program life-long (justify >2 yrs.); investigator case histories (2 yrs. after investigation is discontinued).312.23(a)(6)(iii)(f) and (g), and 312.62(b) and 

(c). 

4.1.2 .............................. Sponsor to justify amount and type of reserve samples ...................... 211.122. 

4.1.2.2 ........................... System for prompt retrieval of PHS specimens and linkage to medical records (recipient and source animal).312.57(a). 

4.1.2.3 ........................... Notify FDA of a clinical episode potentially representing a xenogeneic 

infection.

312.32. 

4.2.2.1 ........................... Document collaborations (transfer of obligation) .................................. 312.52. 

4.2.3.1 ........................... Develop educational materials (sponsor provides investigators with 

information needed to conduct investigation properly).

312.50. 

4.3 ................................. Sponsor to keep records of receipt, shipment, and disposition of investigative drug; investigator to keep records of case histories.312.57 and 312.62(b). 

1The ‘‘Public Health Service Policy on Humane Care and Use of Laboratory Animals’’ (https://olaw.nih.gov/policies-laws/phs-policy.htm). 2AAALAC International Rules of Accreditation (https://www.aaalac.org/accreditation-program/rules-of-accreditation/). 3The 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 made no 

adjustments to our burden estimate 

other than to adjust total burden hours 

by one hour, from 60 to 59 total burden 

hours, to address an inadvertent error in 

disclosure burden in the previous 

submissions to OMB. 

Dated: April 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08737 Filed 4–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0413] 

Baxter Healthcare Corporation, et al.; 

Withdrawal of Approval of 14 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

Health and Human Service (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 14 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The applicants 

notified the Agency in writing that the 

drug products were no longer marketed 

and requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

May 25, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 


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