Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Notices 4033 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; Request 

for Certification of Adult Victims of 

Human Trafficking 

AGENCY: Office on Trafficking in 

Persons; Administration for Children 

and Families; HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF), Office on 

Trafficking in Persons (OTIP), is 

requesting a 3-year extension of the 

Request for Certification of Adult 

Victims of Human Trafficking (RFC) 

form (Office of Management and Budget 

(OMB) #: 0970–0454, expiration 2/28/ 

22). Minor revisions have been made to 

the form, including the addition of a few 

fields that will enable OTIP to be more 

responsive to congressional inquiries, 

federal reporting requirements, and the 

needs of victims. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. All emailed requests should 

be identified by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: The U.S. Department of 

Health and Human Services (HHS) 

provides letters of certification to 

foreign national victims of severe forms 

of trafficking in persons under the 

authority of the Trafficking Victims 

Protection Act of 2000 (TVPA), as 

amended 22 U.S.C. Section 

7105(b)(1)(C) and (E). HHS delegated 

this authority to OTIP. Certification is 

required for foreign national adult 

victims of human trafficking in the 

United States to apply for federally 

funded benefits and services. 

OTIP developed a form for potential 

victims and their advocates, including 

case managers, attorneys, law 

enforcement officers, service providers, 

and other representatives to provide the 

required information for certification to 

HHS in accordance with the TVPA of 

2000, as amended. The RFC form 

(formerly titled Trafficking Victims 

Tracking System) was renamed in order 

to create continuity between the RFC 

and Request for Assistance for Child 

Victims of Human Trafficking (RFA) 

forms (OMB Control Number 0970– 

0362). 

Since the RFC form originally 

received clearance, OTIP modernized its 

request process and launched Shepherd, 

an online case management system, to 

process requests for certification and 

assistance on behalf of foreign national 

adult and minor victims of trafficking. 

The PDF version of the form should 

only be used in exceptional 

circumstances when the online case 

management system is inaccessible. If a 

requester encounters issues submitting a 

request through Shepherd, they may 

submit the RFC form to OTIP as a 

password protected PDF to Trafficking@

acf.hhs.gov. The form asks the requester 

for their identifying information, 

identifying information for the foreign 

national adult in the event the form is 

submitted by a case manager, and 

information describing the victim’s case 

management service needs. The minor 

revisions made to this form enable OTIP 

to better fulfill its mandate in 

accordance with the TVPA of 2000, as 

amended. These revisions also enable 

OTIP to be more responsive to 

congressional inquiries, federal 

reporting requirements, and the needs of 

victims, as the information provided 

will be factored into policy and program 

development efforts. 

Respondents: Potential victims of a 

severe form of trafficking in persons and 

their advocates, including case 

managers, attorneys, law enforcement 

officers, service providers, and other 

representatives. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Total number 

of responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

Request for Certification of Adult Victims of Human Trafficking ............................................................................... 1,300 1 1 1,300 433 

Estimated Total Annual Burden 

Hours: 433. 

Authority: 22 U.S.C. 7105. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–01524 Filed 1–25–22; 8:45 am] 

BILLING CODE 4184–47–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1564] 

Principles for Selecting, Developing, 

Modifying, and Adapting PatientReported Outcome Instruments for 

Use in Medical Device Evaluation; 

Guidance for Industry and Food and 

Drug Administration Staff, and Other 

Stakeholders; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Principles for 

Selecting, Developing, Modifying, and 

Adapting Patient-Reported Outcome 

Instruments for Use in Medical Device 

Evaluation.’’ FDA encourages the 

collection, analysis, and integration of 

patient perspectives in the 

development, evaluation, and 

surveillance of medical devices, 

including digital health technologies. 

Patient-reported outcome (PRO) 

instruments facilitate the systematic 


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4034 Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Notices 

collection of patient perspectives as 

valid scientific evidence to support the 

regulatory and healthcare decisionmaking process. This guidance 

describes principles that should be 

considered when using PRO 

instruments in the evaluation of medical 

devices and provides recommendations 

about the importance of ensuring the 

measures are fit-for-purpose. This 

guidance is not meant to replace the 

Patient-Focused Drug Development 

(PFDD) guidance series. Some of the 

comments received in the docket may 

be addressed in PFDD Guidance #3, 

which is currently in development. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 26, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time 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 

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– 

2020–D–1564 for ‘‘Principles for 

Selecting, Developing, Modifying, and 

Adapting Patient-Reported Outcome 

Instruments for Use in Medical Device 

Evaluation.’’ 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 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Principles for 

Selecting, Developing, Modifying, and 

Adapting Patient-Reported Outcome 

Instruments for Use in Medical Device 

Evaluation’’ to the Office of Policy, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Tarver, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5608, Silver Spring, 

MD 20993–0002, 301–796–6884; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A PRO instrument can be used in a 

clinical investigation to measure the 

effects of a medical intervention or 

changes in the health status of a patient. 

PRO instruments allow for collection of 

certain data as valid scientific evidence 

of safety and effectiveness that is 

complementary to other clinical 

outcomes and/or biomarkers. 

Information from well-defined and 

reliable PRO instruments can provide 

valuable evidence for benefit-risk 

assessments and can be used in medical 

device labeling to communicate the 

effect of a treatment on patient 

symptoms, functioning, or quality of life 

when the labeling is consistent with the 

PRO instrument’s documented 

measurement capability. PRO 

instruments may be used to inform a 

patient’s eligibility for inclusion within 

a study, to capture safety or 

effectiveness outcomes, and may be 

aligned as primary or secondary 

endpoints or used as a stand-alone 

outcome assessment or component of a 

composite endpoint. When data from a 

PRO instrument is used in the 

evaluation of a medical device, FDA 


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Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Notices 4035 

1For more information, please see the FDA PFDD 

Guidance Series website: https://www.fda.gov/ 

drugs/development-approval-process-drugs/fda- patient-focused-drug-development-guidance-seriesenhancing-incorporation-patients-voice-medical. 

determines the validity evidence needed 

to support the PRO instrument’s 

specified use for a regulatory purpose. 

FDA uses the term ‘‘fit-for-purpose’’ to 

describe this flexible approach. As part 

of providing valid scientific evidence to 

assess the safety and effectiveness of 

medical devices, PRO instruments can 

measure the impact of medical devices 

on patient well-being and other 

concepts that may influence payers, 

healthcare providers, and patients when 

making decisions about potential 

treatments or management options. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of August 31, 2020 (85 FR 

53820). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including clarifying and 

expanding examples, making clear the 

language relating to PRO instrument 

scores, as well as clarifying the 

applicability of PRO instruments 

throughout the total product life cycle 

and within clinical studies. Additional 

language on recommendations to 

document modifications, ensure content 

is relevant, and consider patient burden 

was also included. This guidance is not 

meant to replace the Patient-Focused 

Drug Development (PFDD) guidance 

series. Comments received in the docket 

related to the PFDD guidance series 

have been shared with the Center for 

Drug Evaluation and Research (CDER) to 

be considered as part of the 

development of PFDD Guidance #3 

entitled ‘‘Selecting, Developing or 

Modifying Fit-for-Purpose Clinical 

Outcome Assessments’’ and PFDD 

Guidance #4 entitled ‘‘Incorporating 

Clinical Outcome Assessments into 

Endpoints for Regulatory Decision 

Making.’’ 1

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Principles for 

Selecting, Developing, Modifying, and 

Adapting Patient-Reported Outcome 

Instruments for Use in Medical Device 

Evaluation.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance is also available at https://

www.regulations.gov, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances. Persons unable to 

download an electronic copy of 

‘‘Principles for Selecting, Developing, 

Modifying, and Adapting PatientReported Outcome Instruments for Use 

in Medical Device Evaluation’’ may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 18042 and 

complete title to identify the guidance 

you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations and guidance have been 

approved by OMB as listed in the 

following table: 

21 CFR part or guidance Topic OMB control 

No. 

807, subpart E ............................................................................ Premarket notification ................................................................ 0910–0120 

814, subparts A through E .......................................................... Premarket approval .................................................................... 0910–0231 

814, subpart H ............................................................................ Humanitarian Device Exemption ............................................... 0910–0332 

812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078 

860, subpart D ............................................................................ De Novo classification process .................................................. 0910–0844 

‘‘FDA and Industry Procedures for Section 513(g) Requests for 

Information under the Federal Food, Drug, and Cosmetic 

Act’’.

513(g) Request for Information .................................................. 0910–0705 

‘‘Requests for Feedback on Medical Device Submissions: The 

Pre-Submission Program and Meetings with Food and Drug 

Administration Staff’’.

Q-submissions ........................................................................... 0910–0756 

800, 801, and 809 ....................................................................... Medical Device Labeling Regulations ........................................ 0910–0485 

Dated: January 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01377 Filed 1–25–22; 8:45 am] 

BILLING CODE 4164–01–P 


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