27316 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 

reportable conditions, which include 

infectious and non-infectious diseases, 

vary by jurisdiction depending upon 

each jurisdiction’s health priorities and 

needs. Infectious disease agents and 

environmental hazards often cross 

geographical boundaries. Each year, the 

Council of State and Territorial Disease 

Epidemiologists (CSTE), supported by 

CDC, determines which reportable 

conditions should be designated 

nationally notifiable and voluntarily 

submitted to CDC so that information 

can be shared across jurisdictional 

boundaries and both surveillance and 

prevention and control activities can be 

coordinated at regional and national 

levels. 

CDC requests a three-year approval for 

a revision the NNDSS information 

collection. This Revision includes 

requests for approval to receive: (1) Case 

notification data for Chikungunya, 

Dengue-like illness, Non-HPS 

Hantavirus, and Acute Flaccid Myelitis; 

(2) new laboratory and vaccine data 

elements for all conditions; and (3) new 

disease-specific data elements for 

Mumps, Pertussis, and Sexually 

Transmitted Diseases. 

Although this Revision includes case 

notifications that were not part of the 

last NNDSS Revision, the estimate of the 

average burden per response based on 

the burden tables from all of the 

consolidated applications has not 

changed. The burden on the states and 

cities is estimated to be 10 hours per 

response and the burden on the 

territories is estimated to be 5 hours per 

response. The addition of new vaccine, 

laboratory, and disease-specific data 

elements do not add any additional 

burden because the states, territories, 

and cities already collect those data 

elements. There will be no increase in 

burden for the states, territories, and 

cities to send those data elements to 

CDC. The estimated annual burden is 

28,340 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Avg. burden 

per response 

(in hrs.) 

Total burden 

(in hrs.) 

States ................................................ Weekly and Annual .......................... 50 52 10 26,000 

Territories .......................................... Weekly and Annual .......................... 5 52 5 1,300 

Cities ................................................. Weekly and Annual .......................... 2 52 10 1,040 

Total ........................................... ........................................................... ........................ ........................ ........................ 28,340 

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. 2015–11514 Filed 5–12–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–15–15AGK; Docket No. CDC–2015– 

0032] 

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 efforts 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 a new information 

collection request entitled, 

‘‘Understanding Barriers and 

Facilitators to HIV prevention for Men 

Who Have Sex with Men (MSM)’’ to 

conduct qualitative research with most 

at risk HIV-negative MSM. The research 

is intended to understand issues 

surrounding HIV risk for MSM, identify 

influences of high risk behaviors and to 

investigate risk management and 

resiliency among HIV-negative MSM. 

DATES: Written comments must be 

received on or before July 13, 2015. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2015– 

0032 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulation.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 the 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) 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27317 

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 

Understanding Barriers and 

Facilitators to HIV prevention for Men 

Who Have Sex with Men (MSM) (Pulse 

Study)—New—National Center for HIV/ 

AIDS, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The National Center for HIV/AIDS, 

Viral Hepatitis, STD, and TB Prevention 

(NCHHSTP)/Division of HIV/AIDS 

Prevention (DHAP) is requesting 

approval for one year of a data 

collection entitled, ‘‘Understanding 

Barriers and Facilitators to HIV 

prevention for Men Who Have Sex with 

Men (MSM).’’ The purpose of this study 

is to conduct primarily qualitative 

research with most at risk HIV-negative 

MSM. There are four goals to this study: 

(1) Understand issues surrounding HIV 

risk for MSM; (2) learn more about how 

gay community or peer norms, and 

community identification influence risk 

behaviors; (3) understand individual 

HIV risk management, such as having an 

HIV-positive partner with suppressed 

viral load, barriers and facilitators for 

use of biomedical interventions (i.e., 

pre-exposure prophylaxis (PrEP), nonoccupational post-exposure prophylaxis 

(nPEP); and (4) understand factors that 

promote resiliency among HIV-negative 

MSM. 

The present research will be 

conducted in the top five Southern 

metropolitan areas in the United States 

with the highest HIV diagnoses for 

MSM—Atlanta, Georgia; Jackson, 

Mississippi; Miami, Florida; and New 

Orleans and Baton Rouge, Louisiana. 

These cities rank among those in the 

South with the highest prevalence and 

incidence of HIV and sexually 

transmitted infections (STIs) among 

black/African American and Hispanic/

Latino MSM. 

The study population will consist of 

black/African-American and Hispanic/

Latino (1) male adolescents who are 

attracted to men and report they are HIV 

negative or have not been tested and (2) 

adult MSM who are recently tested and 

verified as HIV-negative. 

All study participants will be 13 years 

of age or older. Participants will be 

recruited in the selected cities through 

referrals from Health Departments, 

clinics and other HIV testing centers. In 

addition, we will recruit via word-ofmouth referrals or flyers given out by 

community-based, advocacy, faithbased, and service-providing agencies. 

Primarily, we will use a qualitative 

research design and will include a brief 

quantitative survey to reduce 

participant burden where possible (for 

example, when we do not need to know 

an in-depth answer for sociodemographics, HIV testing history, 

housing status, health insurance status). 

The first portion of the interview 

instrument consists of brief structured 

questions to characterize the 

respondents. The second portion of the 

instrument consists of open-ended indepth qualitative questions. This 

research design was chosen based on 

the exploratory nature of our study 

purpose. 

All data collection tools will be pretested and interviews conducted by 

trained personnel. The data collection 

will take place at a time and place that 

is convenient to the respondent. 

Locations will be private. Data 

collection may be audio-recorded and 

transcribed with the consent of the 

respondent. 

We anticipate that consent forms and 

screener forms to take five minutes to 

complete each. We anticipate 50 percent 

of HIV-negative MSM screened will be 

eligible for the study. The brief 

structured survey (15 minutes) and indepth interview (45 minutes) for HIVnegative MSM are expected to take a 

total of 60 minutes (1 hour) total. We 

will complete interviews for 105 black/ 

African-American and 45 Hispanic/

Latino HIV-negative MSM at greatest 

risk for HIV in high prevalence cities in 

the U.S. South. We anticipate screening 

300 potential respondents. The total 

number of burden hours are 192. 

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 

General Public—Adults ..................... HIV-negative MSM Screener— 

English.

210 1 5/60 18 

General Public—Adults ..................... HIV-negative MSM Screener— 

Spanish.

90 1 5/60 8 

General Public—Adults ..................... HIV-negative MSM Contact Information Form—English.105 1 1/60 2 

General Public—Adults ..................... HIV-negative MSM Contact Information Form—Spanish.45 1 1/60 1 

General Public—Adults ..................... HIV-negative MSM Consent Form— 

English.

95 1 5/60 8 

General Public—Adults ..................... HIV-negative MSM Consent Form— 

Spanish.

35 1 5/60 3 

General Public—Adults ..................... HIV-negative MSM Assent for Minors Form—English.10 1 3/60 1 

General Public—Adults ..................... HIV-negative MSM Assent for Minors Form—Spanish.10 1 3/60 1 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
27318 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

General Public—Adults ..................... HIV-negative MSM In-Depth Interview Guide—English.105 1 1 105 

General Public—Adults ..................... HIV-negative In-Depth Interview 

Guide—Spanish.

45 1 1 45 

Total ........................................... ........................................................... ........................ ........................ ........................ 192 

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. 2015–11512 Filed 5–12–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0404] 

Determination of the Period Covered 

by a No-Tobacco-Sale Order and 

Compliance With an Order; Draft 

Guidance for Tobacco Retailers; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

tobacco retailers entitled 

‘‘Determination of the Period Covered 

by a No-Tobacco-Sale Order and 

Compliance With an Order.’’ The draft 

guidance, when finalized, will represent 

FDA’s current thinking with respect to 

imposing no-tobacco-sale orders 

(NTSOs) on retailers who have 

committed repeated violations of certain 

restrictions on the sale and distribution 

of tobacco products. This draft guidance 

discusses, among other things, the 

period of time covered by an NTSO and 

a retailer’s compliance with an NTSO. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by June 29, 2015. 

ADDRESSES: Submit written requests for 

single copies of this draft guidance to 

the Center for Tobacco Products, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Document Control 

Center, Bldg. 71, Rm. G335, Silver 

Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a fax number to which the draft 

guidance may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

draft guidance. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Colleen Maschal, Center for Tobacco 

Products, Food and Drug 

Administration, Document Control 

Center, Bldg. 71, Rm. G335, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 1–877–287–1373, 

colleen.maschal@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 22, 2009, President Obama 

signed the Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

Control Act) (Pub. L. 111–31) into law. 

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) to give FDA authority to 

regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect public health generally and to 

reduce tobacco use by minors. Section 

906(d) of the FD&C Act (21 U.S.C. 

387f(d)) authorizes FDA to issue 

regulations that restrict the sale and 

distribution of tobacco products if FDA 

determines such regulations would be 

appropriate for the protection of the 

public health. Section 303(f)(8) of the 

FD&C Act (21 U.S.C. 333(f)(8)) 

authorizes FDA to impose an NTSO 

against a person found to have 

committed repeated violations, at a 

particular retail outlet, of restrictions on 

the sale and distribution of tobacco 

products issued under section 906(d) of 

the FD&C Act, such as FDA’s 

‘‘Regulations Restricting the Sale and 

Distribution of Cigarettes and Smokeless 

Tobacco to Protect Children and 

Adolescents’’ (21 CFR part 1140). The 

term ‘‘no-tobacco-sale order’’ refers to 

an order prohibiting the sale of tobacco 

products at a retail outlet indefinitely or 

for a specified period of time under 

section 303(f)(8) of the FD&C Act. A 

‘‘repeated violation’’ means ‘‘at least 5 

violations of particular requirements 

over a 36-month period at a particular 

retail outlet that constitute a repeated 

violation . . .’’ (section 103(q)(1)(A) of 

the Tobacco Control Act). 

FDA conducts inspections of retail 

outlets to evaluate compliance with the 

requirements of the FD&C Act and 

implementing regulations. This draft 

guidance discusses the period of time to 

be covered by an NTSO where there is 

evidence of ‘‘repeated violations’’ at a 

particular retail outlet. It also discusses 

a retailer’s compliance with an NTSO. 

This draft guidance is meant to 

supplement FDA’s guidances entitled 

‘‘Civil Money Penalties and NoTobacco-Sale Orders for Tobacco 

Retailers’’ and ‘‘Civil Money Penalties 

for Tobacco Retailers and No-TobaccoSale Orders: Responses to Frequently 

Asked Questions.’’ 

II. Significance of Draft Guidance 

FDA is issuing this draft guidance 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

with respect to the period of time to be 

covered by NTSOs and retailers’ 

compliance with NTSOs. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES