36068 Federal Register / Vol. 79, No. 122 / Wednesday, June 25, 2014 / Notices 

At present, the NYTS is the most 

comprehensive source of nationally 

representative tobacco data among 

students in grades 9–12, moreover, the 

NYTS is the only source of such data for 

students in grades 6–8. The NYTS has 

provided national estimates of tobacco 

use behaviors, information about 

exposure to pro- and anti-tobacco 

influences, information about racial and 

ethnic disparities in tobacco-related 

topics, and most recently, estimates of 

use of emerging products such as water 

pipes (hookahs) and electronic 

cigarettes (e-cigarettes). Information 

collected through the NYTS is used to 

identify trends over time, to inform the 

development of tobacco cessation 

programs for youth, and to evaluate the 

effectiveness of existing interventions 

and programs. 

CDC plans to request OMB approval 

to conduct additional cycles of the 

NYTS in 2015, 2016, and 2017. The 

survey will be conducted among 

nationally representative samples of 

students attending public and private 

schools in grades 6–12, and will be 

administered to students as an optically 

scannable, eight-page booklet of 

multiple-choice questions. Information 

supporting the NYTS also will be 

collected from state-, district-, and 

school-level administrators and 

teachers. During the 2015–2017 

timeframe, a number of changes will be 

incorporated that reflect the 

collaboration between CDC and the 

Food and Drug Administration that has 

been ongoing since 2011 to assist the 

agency with measuring progress toward 

meeting strategic goals established by 

the Family Smoking Prevention and 

Tobacco Control Act. The 2015 survey 

will examine the following topics: Use 

of cigarettes, smokeless tobacco, cigars, 

pipes, bidis, snus, hookahs, electronic 

vapor products, and dissolvable tobacco 

products; knowledge and attitudes; 

media and advertising; access to tobacco 

products; secondhand smoke exposure; 

and cessation. Given the dynamic 

nature of the tobacco control 

environment, particularly related to 

youth, it may be necessary in the future 

to make additional requests to OMB for 

changes in the NYTS instruments to 

reflect the varying landscape. 

Results of the NYTS will continue to 

be used for public health program 

planning and evaluation. Information 

collected through the NYTS is expected 

to provide measures and data for 

monitoring progress on one of the 20 

tobacco-related objectives for Healthy 

People 2020 and serve as 

complementary data for five other 

tobacco-related objectives. 

OMB approval will be requested for 

three years. Changes described in the 

Revision request include changes to 

instrument content, a decrease in the 

average annualized number of 

respondents, and a decrease in the 

average annualized burden hours. There 

are no changes in the estimated burden 

per response for any type of respondent. 

Participation is voluntary and there are 

no costs to respondents other than their 

time. 

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 

hours 

State Administrators .......................... State-level Recruitment Script for 

the NYTS.

35 1 30/60 18 

District Administrators ....................... District-level Recruitment Script for 

the NYTS.

150 1 30/60 75 

School Administrators ....................... School-level Recruitment Script for 

the NYTS.

220 1 30/60 110 

Teachers ........................................... Data Collection Checklist for the 

NYTS.

973 1 15/60 243 

Students ............................................ National Youth Tobacco Survey ...... 20,077 1 45/60 15,058 

Total ........................................... ........................................................... ........................ ........................ ........................ 15,504 

Leroy 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. 2014–14789 Filed 6–24–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2014–0007] 

Proposed Revised Vaccine Information 

Materials for Td, Tdap, Haemophilus 

influenzae type b, and Rotavirus 

Vaccines 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: Under the National 

Childhood Vaccine Injury Act (NCVIA) 

(42 U.S.C. 300aa–26), the Centers for 

Disease Control and Prevention (CDC) 

within the Department of Health and 

Human Services (HHS) develops 

vaccine information materials that all 

health care providers are required to 

give to patients/parents prior to 

administration of specific vaccines. 

HHS/CDC seeks written comment on 

proposed updated vaccine information 

materials for tetanus/diphtheria vaccine 

(Td), tetanus/diphtheria and acelullar 

pertussis vaccine (Tdap), Haemophilus 

influenzae type b (Hib) vaccine, and 

rotavirus vaccine. 

DATES: Written comments must be 

received on or before August 25, 2014. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2014– 

0007, by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Written comments should be 

addressed to Suzanne Johnson-DeLeon 

(msj1@cdc.gov), National Center for 

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Federal Register / Vol. 79, No. 122 / Wednesday, June 25, 2014 / Notices 36069 

Immunization and Respiratory Diseases, 

Centers for Disease Control and 

Prevention, Mailstop A–19, 1600 Clifton 

Road NE., Atlanta, Georgia 30333. 

Instructions: All submissions received 

must include the agency name and 

docket number. All relevant comments 

received will be posted without change 

to http://regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Skip 

Wolfe (crw4@cdc.gov), National Center 

for Immunization and Respiratory 

Diseases, Centers for Disease Control 

and Prevention, Mailstop A–19, 1600 

Clifton Road NE., Atlanta, Georgia 

30329. 

SUPPLEMENTARY INFORMATION: The 

National Childhood Vaccine Injury Act 

of 1986 (Pub. L. 99–660), as amended by 

section 708 of Public Law 103–183, 

added section 2126 to the Public Health 

Service Act. Section 2126, codified at 42 

U.S.C. 300aa–26, requires the Secretary 

of Health and Human Services to 

develop and disseminate vaccine 

information materials for distribution by 

all health care providers in the United 

States to any patient (or to the parent or 

legal representative in the case of a 

child) receiving vaccines covered under 

the National Vaccine Injury 

Compensation Program (VICP). 

Development and revision of the 

vaccine information materials, also 

known as Vaccine Information 

Statements (VIS), have been delegated 

by the Secretary to the Centers for 

Disease Control and Prevention (CDC). 

Section 2126 requires that the materials 

be developed, or revised, after notice to 

the public, with a 60-day comment 

period, and in consultation with the 

Advisory Commission on Childhood 

Vaccines, appropriate health care 

provider and parent organizations, and 

the Food and Drug Administration. The 

law also requires that the information 

contained in the materials be based on 

available data and information, be 

presented in understandable terms, and 

include: 

(1) A concise description of the 

benefits of the vaccine, 

(2) A concise description of the risks 

associated with the vaccine, 

(3) A statement of the availability of 

the National Vaccine Injury 

Compensation Program, and 

(4) Such other relevant information as 

may be determined by the Secretary. 

The vaccines initially covered under 

the National Vaccine Injury 

Compensation Program were diphtheria, 

tetanus, pertussis, measles, mumps, 

rubella and poliomyelitis vaccines. 

Since April 15, 1992, any health care 

provider in the United States who 

intends to administer one of these 

covered vaccines is required to provide 

copies of the relevant vaccine 

information materials prior to 

administration of any of these vaccines. 

Since then, the following vaccines have 

been added to the National Vaccine 

Injury Compensation Program, requiring 

use of vaccine information materials for 

them as well: Hepatitis B, Haemophilus 

influenzae type b (Hib), varicella 

(chickenpox), pneumococcal conjugate, 

rotavirus, hepatitis A, meningococcal, 

human papillomavirus (HPV), and 

seasonal influenza vaccines. 

Instructions for use of the vaccine 

information materials and copies of the 

materials can be found on the CDC Web 

site at: http://www.cdc.gov/vaccines/

hcp/vis/index.html. 

HHS/CDC is proposing updated 

versions of the Td, Tdap, Hib, and 

rotavirus vaccine information 

statements. We also propose to revise 

the August 26, 2013 Instructions for the 

Use of Vaccine Information Statements 

to include a reference to these vaccine 

information materials. 

The vaccine information materials 

referenced in this notice are being 

developed in consultation with the 

Advisory Commission on Childhood 

Vaccines, the Food and Drug 

Administration, and parent and health 

care provider groups. 

We invite written comment on the 

proposed vaccine information materials 

entitled ‘‘Td Vaccine: What You Need to 

Know;’’ ‘‘Tdap Vaccine: What You Need 

to Know;’’ ‘‘Haemophilus influenzae 

type b Vaccine: What You need to 

Know;’’ and ‘‘Rotavirus Vaccine: What 

You Need to Know.’’ Copies of the 

proposed vaccine information materials 

are available at http://

www.regulations.gov (see Docket 

Number CDC–2014–0007). Comments 

submitted will be considered in 

finalizing these materials. When the 

final materials are published in the 

Federal Register, the notice will include 

an effective date for their mandatory 

use. 

Ron A. Otten, 

Acting Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2014–14805 Filed 6–24–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0120] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Cosmetic Labeling 

Regulations 

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: Fax written comments on the 

collection of information by July 25, 

2014. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0599. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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. 

Cosmetic Labeling Regulations—21 CFR 

Part 701 (OMB Control Number 0910– 

0599)—Extension 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) and the Fair 

Packaging and Labeling Act (the FPLA) 

require that cosmetic manufacturers, 

packers, and distributors disclose 

information about themselves or their 

products on the labels or labeling of 

their products. Sections 201, 301, 502, 

601, 602, 603, 701, and 704 of the FD&C 

Act (21 U.S.C. 321, 331, 352, 361, 362, 

363, 371, and 374, respectively) and 

sections 4 and 5 of the FPLA (15 U.S.C. 

1453 and 1454) provide authority to 

FDA to regulate the labeling of cosmetic 

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