Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices 5219 

Dated: January 12, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–01022 Filed 1–15–21; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0345] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Data To Support 

Drug Product Communications as 

Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) 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 February 

18, 2021. 

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 0910–0695. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

Data to Support Drug Product 

Communications as Used by the Food 

and Drug Administration 

OMB Control Number 0910–0695— 

Extension 

This information collection supports 

Agency outreach efforts. Testing of 

communication messages in advance of 

a communication campaign provides an 

important role in improving FDA 

communications as they allow for an 

indepth understanding of individuals’ 

attitudes, beliefs, motivations, and 

feelings. The methods to be employed 

include individual indepth interviews, 

general public focus group interviews, 

intercept interviews, self-administered 

surveys, gatekeeper surveys, and 

professional clinician focus group 

interviews, all on a voluntary basis. 

The methods to be used serve the 

narrowly defined need for direct and 

informal opinion on a specific topic 

and, as a qualitative research tool, have 

two major purposes: (1) To obtain 

information that is useful for developing 

variables and measures for formulating 

the basic objectives of risk 


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5220 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices 

1 ‘‘Other eligible entities’’ that participate in the 

NPDB are defined in the provisions of Title IV, 

Section 1921, Section 1128E, and implementing 

regulations. In addition, a few federal agencies also 

participate with the NPDB through federal 

memorandums of understanding. Eligible entities 

are responsible for complying with all reporting 

and/or querying requirements that apply; some 

entities may qualify as more than one type of 

eligible entity. Each eligible entity must certify its 

eligibility in order to report to the NPDB, query the 

NPDB, or both. Information from the NPDB is 

available only to those entities specified as eligible 

in the statutes and regulations. Not all entities have 

the same reporting requirements or level of query 

access. 

communication campaigns and (2) to 

assess the potential effectiveness of 

messages and materials in reaching and 

successfully communicating with their 

intended audiences. We will use these 

methods to test and refine our ideas and 

to help develop messages and other 

communications but will generally 

conduct further research before making 

important decisions, such as adopting 

new policies and allocating or 

redirecting significant resources to 

support these policies. We will use this 

mechanism to test messages about 

regulated drug products on a variety of 

subjects related to consumer, patient, or 

healthcare professional perceptions and 

about use of drug products and related 

materials, including but not limited to, 

direct-to-consumer prescription drug 

promotion, physician labeling of 

prescription drugs, medication guides, 

over-the-counter drug labeling, 

emerging risk communications, patient 

labeling, online sale of medical 

products, and consumer and 

professional education. 

Annually, we project about 45 

communication studies using the 

variety of test methods listed in this 

document. We are requesting an 

extension of these burden hours so as 

not to restrict our ability to gather 

information on public sentiment for 

FDA’s proposals in its regulatory and 

communications programs. 

In the Federal Register of June 17, 

2020 (85 FR 36591), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

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 

Total annual 

responses 

Average burden 

per response Total hours 

Interviews/Surveys ............................ 43,875 1 43,875 0.21925 (12 minutes) ....................... 9,620 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: January 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–01030 Filed 1–15–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Information Collection 

Request Title: National Practitioner 

Data Bank for Adverse Information on 

Physicians and Other Health Care 

Practitioners—45 CFR Part 60 

Regulations and Forms, OMB No. 

0915–0126—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than February 18, 

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 Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

National Practitioner Data Bank for 

Adverse Information on Physicians and 

Other Health Care Practitioners—45 

CFR Part 60 Regulations and Forms, 

OMB No. 0915–0126—Revision. 

Abstract: This is a request for OMB’s 

approval for a revision to the 

information collection contained in 

regulations found at 45 CFR part 60 

governing the National Practitioner Data 

Bank (NPDB) and the forms to be used 

in registering with, reporting 

information to, and requesting 

information from the NPDB. 

Administrative forms are also included 

to aid in monitoring compliance with 

federal reporting and querying 

requirements. Responsibility for NPDB 

implementation and operation resides 

in HRSA’s Bureau of Health Workforce. 

The intent of the NPDB is to improve 

the quality of health care by 

encouraging entities such as hospitals, 

State licensing boards, professional 

societies, and other eligible entities 1

providing health care services to 

identify and discipline those who 

engage in unprofessional behavior, and 

to restrict the ability of incompetent 

health care practitioners, providers, or 

suppliers to move from state to state 

without disclosure or discovery of 

previous damaging or incompetent 

performance. It also serves as a fraud 

and abuse clearinghouse for the 

reporting and disclosing of certain final 

adverse actions (excluding settlements 

in which no findings of liability have 

been made) taken against health care 

practitioners, providers, or suppliers by 

health plans, federal agencies, and state 

agencies. Users of the NPDB include 

reporters (entities that are required to 


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