44730 Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Notices 

experimental designs in order to capture 

how different questions function in a 

field setting. Similar methodology has 

been adopted by other federal agencies, 

as well as by academic and commercial 

survey organizations. 

In 2021–2024, NCHS/CCQDER staff 

plan to continue research on methods 

evaluation and general questionnaire 

design research. We envision that over 

the next three years, NCHS/CCQDER 

will work collaboratively with survey 

researchers from universities and other 

Federal agencies to define and examine 

several research areas, including, but 

not limited to: (1) Differences between 

face-to-face, telephone, and virtual/ 

video over internet cognitive 

interviewing, (2) effectiveness of 

different approaches to cognitive 

interviewing, such as concurrent and 

retrospective probing, (3) reactions of 

both survey respondents and survey 

interviewers to the use of ComputerAssisted Personal Interviewing (CAPI), 

Audio Computer-Assisted SelfInterview (ACASI), video over internet/ 

virtual, (4) social, cultural and linguistic 

factors in the question response process, 

and (5) recruitment and respondent 

participation at varying levels of 

incentive in an effort to establish 

empirical evidence regarding 

remuneration and coercion. Procedures 

for each of these studies will be similar 

to those applied in the usual testing of 

survey questions. For example, 

questionnaires that are of current 

interest (such as RANDS and NIOSH) 

may be evaluated using several of the 

techniques described above. In addition, 

different versions of a survey question 

will be developed, and the variants then 

administered to separate groups of 

respondents in order to study the 

cognitive processes that account for the 

differences in responses obtained across 

different versions. 

These studies will be conducted 

either by CCQDER staff, DHHS staff, or 

NCHS contractors who are trained in 

cognitive interviewing techniques. The 

results of these studies will be applied 

to our specific questionnaire 

development activities in order to 

improve the methods that we use to 

conduct questionnaire testing, and to 

guide questionnaire design in general. 

OMB approval is requested for three 

years. Participation is voluntary. We are 

requesting 9,455 annualized hours, 

totaling 28,365 over three years. This is 

an increase of 1,672 hours per year or 

5,016 hours over three years. The 

requested increases are due to an 

anticipated increase in the number and 

size of projects being undertaken. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Individuals or households ............................... Eligibility Screeners ........................................ 4,400 1 5/60 

Individuals or households ............................... Developmental Questionnaires ...................... 8,750 1 55/60 

Individuals or households ............................... Respondent Data Collection Sheet ................ 8,750 1 5/60 

Individuals or households ............................... Focus Group Documents ............................... 225 1 90/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–17349 Filed 8–12–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–1880 and CMS– 

1856] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by September 13, 

2021. 

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. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 


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Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Notices 44731 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Request for 

Certification as Supplier of Portable XRay Services under the Medicare/ 

Medicaid Program; Use: CMS–1880 is 

initially completed by suppliers of 

portable X-ray services, expressing an 

interest in and requesting participation 

in the Medicare program. The CMS– 

1880 form initiates the process of 

obtaining a decision as to whether the 

conditions of coverage are met by the 

portable X-ray supplier seeking 

Medicare participation. It also promotes 

data reduction or introduction to, and 

retrieval from, the Certification and 

Survey Provider Enhanced Reporting 

(CASPER) by the CMS Regional Offices 

(ROs). The CMS–1880 form is also 

completed by current Medicare 

participating portable x-ray supplier 

during each recertification survey. Form 

Numbers: CMS–1880 (OMB control 

number: 0938–0027); Frequency: 

Occasionally; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 104; Total Annual 

Responses: 104; Total Annual Hours: 

26. (For policy questions regarding this 

collection contact Caroline Gallaher at 

410–786–8705.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Request for 

Certification in the Medicare/Medicaid 

Program for Provides of Outpatient 

Physical Therapy and/or SpeechLanguage Pathology; Use: The form is 

used as an application to be completed 

by providers of outpatient physical 

therapy and/or speech-language 

pathology services requesting 

participation in the Medicare and 

Medicaid programs. This form initiates 

the process of obtaining a decision as to 

whether the conditions of participation 

are met as a provider of outpatient 

physical therapy and/or speechlanguage pathology services. The form is 

used by the State Agencies (SAs) to 

enter the new prospective provider into 

the national surveyor database. The 

form is also used for recertification of 

the provider. Surveyors are no longer 

required to use form CMS–1856. 

Surveyors are now able to access survey 

resources electronically from the 

national surveyor database, as a result, 

the need for surveyors to carry printed 

copies of the survey information data is 

no longer efficient. Form Number: 

CMS–1856 (OMB control number: 

0938–0065); Frequency: Annually, 

occasionally; Affected Public: Private 

sector—Business or other for-profit and 

Not-for-profit institutions; Number of 

Respondents: 195; Total Annual 

Responses: 195; Total Annual Hours: 

49. (For policy questions regarding this 

collection contact Caecilia Blondiaux at 

410–786–2190.) 

Dated: August 10, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–17374 Filed 8–12–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1245] 

Drug Products Approved in 

Abbreviated New Drug Applications 

Before the Enactment of the HatchWaxman Amendments; Establishment 

of a Public Docket; Request for 

Comments 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the establishment of a 

public docket to solicit comments on 

several issues related to FDA’s postapproval regulation of certain drug 

products approved in abbreviated 

applications before the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Hatch-Waxman 

Amendments) amended the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) to establish the current abbreviated 

new drug application (ANDA) process. 

Because these pre-Hatch-Waxman 

abbreviated new drug applications 

(referred to in this notice as ‘‘PANDAs’’) 

were submitted and approved under the 

provisions of the FD&C Act that apply 

to 505(b) new drug applications, they 

can serve as a reference listed drug 

(RLD) for ANDAs and can also be a 

listed drug relied on by 505(b)(2) 

applications. PANDAs have historically 

been overseen by FDA’s Office of 

Generic Drugs, and FDA is aware that 

there may be some confusion about the 

applicability of certain statutory and 

regulatory provisions to PANDAs. FDA 

is seeking input from holders of 

PANDAs and other interested persons 

regarding whether there are regulatory 

or policy rationales for treating PANDAs 

differently from other 505(b) 

applications in certain respects. 

DATES: Submit either electronic or 

written comments by December 13, 

2021. 

ADDRESSES: FDA is establishing a docket 

for public comments on this document. 

The docket number is FDA–2020–N– 

1245. The docket will close on 

December 13, 2021. Submit either 

electronic or written comments by that 

date. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before December 13, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of December 13, 2021. 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. 

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 

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: 


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