12692 Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

501.22(k); labeling of color additive or lake of color additive; labeling of color additives not subject to certification.3,120 0.8292 2,587 0.25 .............

(15 minutes). 

647 

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: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04461 Filed 3–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–3077] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Obtaining Information To Understand 

and Challenges and Opportunities 

Encountered by Compounding 

Outsourcing Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that a collection of 

information entitled ‘‘Obtaining 

Information to Understand and 

Challenges and Opportunities 

Encountered by Compounding 

Outsourcing Facilities’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

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: On 

December 18, 2020, the Agency 

submitted a proposed collection of 

information entitled ‘‘Obtaining 

Information to Understand and 

Challenges and Opportunities 

Encountered by Compounding 

Outsourcing Facilities’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0883. The approval expires on 

January 31, 2022. A copy of the 

supporting statement for this 

information collection is available on 

the internet at https://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04470 Filed 3–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1228] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Study of Multiple 

Indications in Direct-to-Consumer 

Television Advertisements 

AGENCY: Food and Drug Administration, 

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 April 5, 

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 title 

of this information collection is ‘‘Study 

of Multiple Indications in Direct-toConsumer Television Advertisements.’’ 

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. 

Study of Multiple Indications in Directto-Consumer Television Advertisements 

OMB Control Number 0910–NEW 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes the 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, focusing in particular on three 

main topic areas: (1) Advertising 

features, including content and format; 

(2) target populations; and (3) 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 


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