39586 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–17581 Filed 8–18–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–17–0214; Docket No. CDC–2017– 

0063] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on proposed and/or 

continuing information collections, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on the National Health 

Interview Survey (NHIS). The annual 

National Health Interview Survey is a 

major source of general statistics on the 

health of the U.S. population. 

DATES: Written comments must be 

received on or before October 20, 2017. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2017– 

0063 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Leroy A. Richardson, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE., MS– 

D74, Atlanta, Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. All relevant comments 

received will be posted without change 

to Regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

Regulations.gov. 

Please note: All public comment 

should be submitted through the 

Federal eRulemaking portal 

(regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Leroy A. 

Richardson, Information Collection 

Review Office, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE., MS–D74, Atlanta, Georgia 

30329; phone: 404–639–7570; Email: 

omb@cdc.gov. 

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. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. 

Proposed Project 

National Health Interview Survey 

(NHIS) (OMB Control No. 0920–0124, 

Exp. 12/31/2019)—Revision—National 

Center for Health Statistics (NCHS), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

Section 306 of the Public Health 

Service (PHS) Act (42 U.S.C.), as 

amended, authorizes that the Secretary 

of Health and Human Services (HHS), 

acting through NCHS, shall collect 

statistics on the extent and nature of 

illness and disability of the population 

of the United States. 

The annual National Health Interview 

Survey (NHIS) is a major source of 

general statistics on the health of the 

U.S. population and has been in the 

field continuously since 1957. This 

voluntary and confidential householdbased survey collects demographic and 

health-related information from a 

nationally-representative sample of 

households and noninstitutionalized, 

civilian persons throughout the country. 

NHIS data have long been used by 

government, academic, and private 

researchers to evaluate both general 

health and specific issues, such as 

smoking, diabetes, health care coverage, 

and access to health care. The survey is 

also a leading source of data for the 

Congressionally-mandated ‘‘Health US’’ 

and related publications, as well as the 

single most important source of 

statistics to track progress toward 

Departmental health objectives. 

The 2018 NHIS questionnaire remains 

largely unchanged from its 2017 

version, with the exception of new 

supplements that are being added on 

asthma and cancer control. These 

supplements replace those from 2017 on 

receipt of culturally and linguistically 

appropriate health care services, 

epilepsy, cognitive disability, 

complementary health, hepatitis B/C 

screening, vision, and heart disease and 

stroke prevention. Continuing from 

2017 are questions about access to and 

utilization of care and barriers to care, 

chronic pain, diabetes, disability and 

functioning, family food security, ABCS 

of heart disease and stroke prevention, 

immunizations, smokeless tobacco and 

e-cigarettes, and children’s mental 

health. 

In addition, in the last quarter of 

2018, a portion of the regular 2018 NHIS 

sample will be used to carry out a dress 

rehearsal and systems test of the 

redesigned NHIS questionnaire that is 

scheduled for launch in January 2019. 

The redesigned questionnaire revises 

the NHIS both in terms of content and 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 39587 

structure in order to (1) improve the 

measurement of covered health topics, 

(2) reduce respondent burden by 

shortening the length of the 

questionnaire and seamlessly 

integrating supplements, (3) harmonize 

overlapping content with other federal 

health surveys, (4) establish a long-term 

structure of ongoing and periodic topics, 

and (5) incorporate advances in survey 

methodology and measurement. 

As in past years, and in accordance 

with the 1995 initiative to increase the 

integration of surveys within the DHHS, 

respondents to the 2018 NHIS will serve 

as the sampling frame for the Medical 

Expenditure Panel Survey. In addition, 

a subsample of NHIS respondents and/ 

or members of commercial survey 

panels may be identified to participate 

in short, Web-based methodological and 

cognitive testing activities to evaluate 

the redesigned questionnaire and/or 

inform the development of new rotating 

and supplemental content using Web 

and/or mail survey tools. 

There is no cost to the respondents 

other than their time. Clearance is 

sought for three years, to collect data for 

2018–2020. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Adult Household Member ................. Main Household Composition and 

Family Core.

39,375 1 23/60 15,094 

Sample Adult ..................................... Main Adult Core ............................... 31,500 1 15/60 7,875 

Adult Family Member ........................ Main Child Core ............................... 12,250 1 10/60 2,042 

Adult Family Member ........................ Main Supplements ........................... 45,000 1 20/60 15,000 

Adult Household Member ................. Redesigned Family Core ................. 5,625 1 23/60 2,156 

Sample Adult ..................................... Redesigned Adult Core .................... 4,500 1 15/60 1,125 

Adult Family Member ........................ Redesigned Child Core .................... 1,750 1 10/60 292 

Adult Family Member ........................ Methodological Projects ................... 15,000 1 20/60 5,000 

Adult Family Member ........................ Reinterview Survey .......................... 5,000 1 5/60 417 

Total ........................................... ........................................................... ........................ ........................ ........................ 49,000 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–17582 Filed 8–18–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2013–E–0264; FDA– 

2013–E–0263; and FDA–2013–E–0218] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; RECUVYRA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for RECUVYRA and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that animal drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (in the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by October 20, 2017. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

February 20, 2018. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before October 20, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 20, 2017. 

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. 

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 


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