Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 24313 

explaining that Librax is not subject to 

review under DESI because a new drug 

application for Librax was approved by 

the Agency on September 1, 1966, and 

at that time the Agency determined that 

Librax was safe and effective for the 

indications set forth in its labeling, 

(consistent with the Stipulation for 

Dismissal in Hoffman-La Roche, Inc. v. 

Richardson, et al., Civil Action 11–73 

(D.N.J. August 2, 1973)). On June 2, 

2016, Valeant responded by 

withdrawing its hearing request. 

There are no longer outstanding 

hearing requests pertaining to drug 

products containing an anticholinergic 

or antispasmodic in combination with a 

sedative, and single-entity 

antispasmodic drug products, in oral 

dosage form under Docket No. FDA– 

1975–N–0336, DESI 10837. Shipment in 

interstate commerce of any drug product 

identified in this docket under DESI 

10837, or any IRS product, that is not 

the subject of an approved NDA or 

ANDA is unlawful as of the applicable 

date of this notice (see DATES). Any 

person who wishes to determine 

whether a specific product is covered by 

this notice should write to Jeffrey 

Trunzo (see FOR FURTHER INFORMATION

CONTACT). Firms should be aware that, 

after the applicable date of this notice 

(see DATES), FDA intends to take 

enforcement action without further 

notice against any firm that 

manufactures or ships in interstate 

commerce any unapproved product 

covered by this notice. 

III. Discontinued Products 

Firms must notify the Agency of 

certain product discontinuations in 

writing under section 506C(a) of the 

FD&C Act (21 U.S.C. 356c) (see https:// 

www.fda.gov/Drugs/DrugSafety/ 

DrugShortages/ucm142398.htm). Some 

firms may have previously discontinued 

manufacturing or distributing products 

covered by this notice without 

discontinuing the listing as required 

under section 510(j) of the FD&C Act (21 

U.S.C. 360(j)). Other firms may 

discontinue manufacturing or 

distributing listed products in response 

to this notice. All firms are required to 

electronically update the listing of their 

products under 510(j) of the FD&C Act 

to reflect discontinuation of unapproved 

products covered by this notice (21 CFR 

207.57(b)). Questions on electronic drug 

listing updates should be sent to 

eDRLS@fda.hhs.gov. In addition to the 

required update, firms can also notify 

the Agency of product discontinuation 

by sending a letter, signed by the firm’s 

chief executive officer and fully 

identifying the discontinued product(s), 

including the product National Drug 

Code (NDC) number(s), and stating that 

the manufacturing and/or distribution of 

the product(s) have been discontinued. 

The letter should be sent electronically 

to Jeffrey Trunzo (see FOR FURTHER

INFORMATION CONTACT). FDA plans to 

rely on its existing records, including its 

drug listing records, the results of any 

future inspections, or other available 

information, when it identifies violative 

products for enforcement action. 

IV. Reformulated Products 

FDA cautions firms against 

reformulating products and marketing 

under the same name or substantially 

the same name (including a new name 

that contains the old name). 

Reformulated products marketed under 

a name previously identified with a 

different active ingredient or 

combinations of active ingredients have 

the potential to confuse healthcare 

practitioners and harm patients. 

Dated: April 20, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08740 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–0081] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tradeoff Analysis 

of Prescription Drug Product Claims in 

Direct-to-Consumer and Healthcare 

Provider Promotion 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on research entitled 

‘‘Tradeoff Analysis of Prescription Drug 

Product Claims in Direct-to-Consumer 

and Healthcare Provider Promotion.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 24, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before June 24, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 24, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–N–0081 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Tradeoff 

Analysis of Prescription Drug Product 


khammond on DSKJM1Z7X2PROD with NOTICES
24314 Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 

Claims in Direct-to-Consumer and 

Healthcare Provider Promotion.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

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

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the information collection: 

Jonna Capezzuto, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–3794, PRAStaff@

fda.hhs.gov. For copies of the 

questionnaire: Office of Prescription 

Drug Promotion (OPDP) Research Team, 

DTCresearch@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Tradeoff Analysis of Prescription Drug 

Product Claims in Direct-to-Consumer 

and Healthcare Provider Promotion 

OMB Control Number 0910–NEW 

I. Background 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 1003(d)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 393(d)(2)(C)) authorizes 

FDA to conduct research relating to 

drugs and other FDA-regulated products 

in carrying out the provisions of the 

FD&C Act. 

The Office of Prescription Drug 

Promotion’s (OPDP) mission is to 

protect the public health by helping to 

ensure that prescription drug promotion 

is truthful, balanced, and accurately 

communicated. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have consistently 

conducted research to evaluate the 

aspects of prescription drug promotion 

that are most central to our mission. Our 

research focuses in particular on three 

main topic areas: Advertising features, 

including content and format; target 

populations; and research quality. 

Through the evaluation of advertising 

features, we assess how elements such 

as graphics, format, and disease and 

product characteristics impact the 

communication and understanding of 

prescription drug risks and benefits. 

Focusing on target populations allows 

us to evaluate how understanding of 

prescription drug risks and benefits may 

vary as a function of audience, and our 

focus on research quality aims at 

maximizing the quality of research data 

through analytical methodology 

development and investigation of 

sampling and response issues. This 

study will inform the first and second 

topic areas, advertising features and 

target populations. 

Because we recognize that the 

strength of data and the confidence in 

the robust nature of the findings are 

improved by using the results of 

multiple converging studies, we 

continue to develop evidence to inform 

our thinking. We evaluate the results 

from our studies within the broader 

context of research and findings from 

other sources, and this larger body of 

knowledge collectively informs our 

policies as well as our research program. 

Our research is documented on our 

home page, which can be found at: 

https://www.fda.gov/about-fda/centerdrug-evaluation-and-research-cder/ 

office-prescription-drug-promotionopdp-research. The website includes 

links to the latest Federal Register 

notices and peer-reviewed publications 

produced by our office. 

The proposed research examines the 

relative importance of prescription drug 

product information such as 

prescription drug efficacy, risk, 

adherence, and patient preference 

claims in two medical conditions (type 

2 diabetes and psoriasis) in consumer 

and physician samples. When 

confronted with an important decision, 

people tend to make choices that reflect 

a series of tradeoffs between certain 

desirable and undesirable attributes of a 

product, service, or experience. 

Pharmaceutical manufacturers provide 

information about prescription drug 

products, including side effects, 

contraindications, and effectiveness 

through product labeling and 

promotional materials (21 CFR 202.1(e)). 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 24315 

The treatment preferences of diagnosed 

consumers and treating physicians have 

been shown to be influenced by certain 

characteristics, such as the perceived 

drug’s impact on quality of life, 

complexity of dosage regimens, mode of 

administration, cost to family and self, 

and marketing claims unrelated to 

medicinal properties (Refs. 1 to 5). 

Although diagnosed consumers may 

weigh the risks, benefits, or other salient 

characteristics of prescription drug 

products differently than physicians, 

little research directly compares the 

treatment preferences of these two 

groups (Ref. 6). Understanding the 

tradeoffs among drug product 

characteristics diagnosed consumers 

make—and how the tradeoffs could 

potentially differ from the tradeoffs 

made by physicians—will provide 

valuable insight into the relevance and 

impact of various product attributes and 

promotional claims on informed choices 

and treatment decisions. 

We intend to examine these tradeoffs 

using a choice-based conjoint analysis, 

also known as a discrete choice 

experiment. Conjoint analysis is a broad 

class of survey-based techniques used to 

estimate how attractive or influential 

different features of choice options or 

product attributes are in determining 

purchase behavior or treatment choices 

(Ref. 7). Conjoint analysis can be used 

to examine the joint effects and tradeoffs 

of multiple variables or product 

attributes on decisions. A choice-based 

conjoint analysis is based on the 

principle that products are composed of 

a set of attributes, and each attribute can 

be described using a finite number of 

levels. In the proposed research, 

participants will be shown a carefully 

designed sequence of choice tasks 

containing up to five hypothetical 

product attributes—in this case, profiles 

describing fictitious prescription drug 

products for either type 2 diabetes or 

psoriasis. Using data from the choices 

that participants make across these 

tasks, we can use statistical techniques 

to draw inferences about the relative 

value they place on different product 

attributes, estimate the relative 

importance of different attributes, 

explore the tradeoffs that consumers 

and physicians are willing to make to 

avoid or accept specific attribute levels, 

and compare the preferences of these 

two groups (Ref. 8). 

We estimate that participation in the 

study will take approximately 20 

minutes. Adult participants aged 18 

years or older will be recruited by email 

through an internet panel, and 

participant eligibility will be 

determined with a screener at the 

beginning of the online survey. The 

consumer sample will consist of adults 

who self-report as having been 

diagnosed by a healthcare provider with 

either psoriasis or type 2 diabetes. For 

the consumer sample, we will exclude 

individuals who work in healthcare 

settings because their knowledge and 

experiences may not reflect those of the 

average consumer. The physician 

sample will consist of primary care 

physicians and specialists who report 

treating patients with psoriasis or type 

2 diabetes. For the physician sample, we 

will exclude individuals who spend less 

than 50 percent of their time on direct 

patient care. Department of Health and 

Human Services employees and 

individuals who work in the marketing, 

advertising, or pharmaceutical 

industries will be excluded from both 

respondent groups. Respondents will 

receive a survey invitation with a 

unique password protected link. All 

panel members are recruited following a 

double opt-in process. Sample sizes 

were estimated by combining 

approaches for conjoint analysis 

suggested by Orme (Ref. 9) and Johnson 

et al. (Ref. 10). 

The target sample size for the main 

study is 800 physicians and 800 

consumers, with half of each cohort 

focusing on treatments for psoriasis and 

the other half focusing on treatments for 

type 2 diabetes. Prior to conducting the 

main study, we will conduct at least one 

pretest. If the first pretest reveals that 

changes to the measurement 

instruments, stimuli, or procedures are 

required, a second pretest will be 

conducted with revised materials. The 

target sample size for each wave of 

pretests is 60 physicians and 60 

consumers. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 2

Total annual 

responses 

Average burden per 

response 3 Total hours 

Pretest 1 Screener, Physicians 4 .................. 95 1 95 0.08 (5 minutes) ................... 8 

Pretest 1 Screener, Consumers 4 ................. 95 1 95 0.08 (5 minutes) ................... 8 

Physician Pretest 1 ....................................... 66 1 66 0.33 (20 minutes) ................. 22 

Consumer Pretest 1 ...................................... 66 1 66 0.33 (20 minutes) ................. 22 

Pretest 2 Screener, Physicians 4 5 ................ 95 1 95 0.08 (5 minutes) ................... 8 

Pretest 2 Screener, Consumers 4 5 ............... 95 1 95 0.08 (5 minutes) ................... 8 

Physician Pretest 2 4 ..................................... 66 1 66 0.33 (20 minutes) ................. 22 

Consumer Pretest 2 4 ................................... 66 1 66 0.33 (20 minutes) ................. 22 

Physician Main Study Screener 4 ................. 1,258 1 1,258 0.08 (5 minutes) ................... 101 

Physician Main Study ................................... 880 1 880 0.33 (20 minutes) ................. 290 

Consumer Main Study Screener 4 ................ 1,258 1 1,258 0.08 (5 minutes) ................... 101 

Consumer Main Study .................................. 880 1 880 0.33 (20 minutes) ................. 290 

Total ....................................................... ........................ ........................ 4,920 ............................................... 902 

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

2As with most online and mail surveys, it is always possible that some participants are in the process of completing the survey when the target 

number is reached and that those surveys will be completed and received before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for both samples in the study. 3Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format. 

4 Number of screener respondents assumes a 70 percent eligibility rate with targeted recruitment. 

5Pretest 2 will be conducted only if changes to study materials are made in response to the findings of Pretest 1. 


khammond on DSKJM1Z7X2PROD with NOTICES
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 


khammond on DSKJM1Z7X2PROD with NOTICES