Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 51897 

family; academic researchers in the 

social and public health sciences; 

journalists, and many others. 

CDC requests OMB approval to 

reinstate NSFG data collection for three 

years, with changes. Each year, about 

13,500 households will be screened, 

with about 5,000 participants 

interviewed annually. Interviews are 

expected to average 50 minutes for 

males and 75 minutes for females. 

Proposed changes include streamlining 

information collection content in some 

sections as well as adding a limited 

number of new questions, including 

questions about childhood experiences 

that may impact fertility and health 

outcomes in adulthood. Approximately 

10% of respondents will be asked to 

participate in a brief verification 

process. Responses to the NSFG are 

confidential. 

In addition, CDC plans to conduct 

several methodological studies designed 

to improve the efficiency and validity of 

NSFG data collection for the purposes 

described above. These include a test of 

face-to-face interview mode compared 

to multi-mode participation that also 

includes a web-based survey 

component; test of an electronic life 

history calendar; enhanced introductory 

and reminder emails to increase 

response rate; and collection of 

auxiliary information to reduce 

nonresponse bias or improve 

nonresponse bias estimation. 

Participation is voluntary, and there is 

no cost to respondents other than their 

time. The total estimated annualized 

time burden to respondents is 6,122 

hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Form Number of 

responses 

Responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Household member ................................................................. Screener Interview ................. 13,500 1 3/60 

Household Female 15–49 years of age ................................. Female Interview .................... 2,750 1 75/60 

Household Male 15–49 years of age ...................................... Male Interview ........................ 2,250 1 50/60 

Household member ................................................................. Screener Verification .............. 1,350 1 2/60 

Household Individual 15–49 years of age .............................. Main Interview Verification ..... 500 1 5/60 

Household Female 15–49 years of age ................................. Respondent debriefing questions about calendar.325 1 3/60 

Household member ................................................................. Phase 4 nonresponse followup questions.375 1 5/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–20154 Filed 9–16–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0180] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Clearance 

for the Collection of Quantitative Data 

on Tobacco Products and 

Communications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 October 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 0910–0810. 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. 

Generic Clearance for the Collection of 

Quantitative Data on Tobacco Products 

and Communications 

OMB Control Number 0910–0810— 

Extension 

In order to conduct educational and 

public information programs relating to 

tobacco use as authorized by section 

1003(d)(2)(D) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(D)), FDA’s Center for Tobacco 

Products will conduct research and use 

a variety of media to inform and educate 

the public, tobacco retailers, and health 

professionals about the health risks of 

tobacco use, how to quit using tobacco 

products, and FDA’s role in regulating 

tobacco. 

To ensure that these educational and 

public information programs have the 

highest potential to be received, 

understood, and accepted by those for 

whom they are intended, the Center for 

Tobacco Products will conduct research 

and develop health messages relating to 

the control and prevention of disease. In 

conducting such research, FDA will use 

quantitative methods (i.e., surveys, 

experimental studies) for studies about 

tobacco products. These studies may be 

used to collect information related to 

foundational research informing 

message development or the formative 

pretesting of tobacco communication 

messages and other materials directed at 

consumers. This type of research 

involves: (1) Assessing audience 

knowledge, attitudes, behaviors, and 

other characteristics for the purpose of 

determining the need for and 

developing health messages, 

communication strategies, and public 

information programs; (2) pretesting 

these health messages, strategies, and 

program components while they are in 

developmental form to assess audience 

51898 Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 

comprehension, reactions, and 

perceptions; and (3) adding to the 

regulatory science knowledge base. 

Quantitative studies play an important 

role in exploring areas of research and 

gathering information because they can 

be used to summarize a population of 

interest on key variables or reveal 

systematic relationships between 

variables. 

Foundational research to inform 

message development and the formative 

pretesting of messages are a staple of 

best practices in communications 

research. Obtaining voluntary feedback 

from intended audiences during the 

development of messages and materials 

is crucial for the success of every 

communication program. The purpose 

of obtaining information from formative 

pretesting is that it allows FDA to 

improve materials and strategies while 

revisions are still affordable and 

possible. Formative pretesting can also 

avoid potentially expensive and 

dangerous unintended outcomes caused 

by audiences interpreting messages in a 

way that was not intended by the 

drafters. By maximizing the 

effectiveness of messages and strategies 

for reaching targeted audiences, the 

frequency with which tobacco 

communication messages need to be 

modified should be greatly reduced. 

The voluntary information collected 

will serve the primary purpose of 

providing FDA information about 

various measures of ad performance 

including message comprehension, 

perceived effectiveness, emotional 

responses and knowledge, attitudes, and 

behavior change to assess the ability of 

messages, advertisements, and materials 

to reach and successfully communicate 

with their intended audiences. 

Quantitative testing messages and other 

materials with a sample of the target 

audience will allow FDA to refine 

messages, advertisements, and materials 

directed at consumers while the 

materials are still in the developmental 

stage. 

In addition, quantitative information 

is needed by FDA to track changes in 

response to policy and regulatory 

actions and to expand the tobacco 

regulatory science base by providing 

information on changing behaviors, 

knowledge, and attitudes about tobacco 

products, including postmarketing 

surveillance of tobacco products. 

In the Federal Register of March 5, 

2021 (86 FR 12952), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One PRA related comment 

was received. 

(Comment) The comment suggested 

specific types of messages that FDA 

should test and then implement in 

public health campaigns. 

(Response) FDA appreciates the 

comment. The content and focus on 

studies submitted through this generic 

clearance will depend on Agency 

priorities and needs, which are not yet 

determined at this time. 

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 

Screener ............................................................... 485,580 1 485,580 0.083 (5 minutes) ......... 40,465 

Self-Administered Surveys ................................... 133,728 1 133,728 0.33 (20 minutes) ......... 44,576 

Total ............................................................... ........................ ........................ ........................ ....................................... 85,041 

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

Number of respondents to be included 

in each new survey will vary, 

depending on the nature of the material 

or message being tested and the target 

audience. Table 1 provides examples of 

the types of activities that may be 

administered and estimated burden 

levels during the 3-year period. Time to 

read, review, or complete the activity is 

built into the ‘‘Average Burden per 

Response’’ figures. Our estimated 

burden for the information collection 

reflects an overall increase of 60,000 

hours and a corresponding increase of 

461,808 responses. We attribute the 

adjustment to an increase in the number 

of new quantitative studies that are 

anticipated underneath this information 

collection during the next 3 years 

(proposed extension). 

Dated: September 10, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20057 Filed 9–16–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidances for Ferric 

Oxyhydroxide; Revised Draft 

Guidances for Industry; 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 revised 

draft guidances for industry entitled 

‘‘Draft Guidance for Ferric 

Oxyhydroxide.’’ The revised draft 

guidances, when finalized, will provide 

product-specific recommendations on, 

among other things, the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) for ferric oxyhydroxide oral 

tablets (previously sucroferric 

oxyhydroxide) and ferric oxyhydroxide 

intravenous injectable (previously iron 

sucrose). 

DATES: Submit either electronic or 

written comments on the draft 

guidances by November 16, 2021 to 

ensure that the Agency considers your 

comment on these draft guidances 

before it begins work on the final 

versions of the guidances. 

ADDRESSES: You may submit comments 

on any guidance 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,