68888 Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices 

annualized burden of 607 hours per 

year. 

There are no costs to participants 

other than the time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Private companies .......................................... EXCEL data template .................................... 28 260 5/60 

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. 2014–27350 Filed 11–18–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[CFDA Numbers: 93.592] 

Announcing the Award of a SingleSource Program Expansion 

Supplement Grant to the National 

Resource Center on Domestic Violence 

(NRCDV) in Harrisburg, PA 

AGENCY: Family and Youth Services 

Bureau, ACYF, ACF, HHS. 

ACTION: Notice of the award of a singlesource program expansion supplement 

grant under the Family Violence 

Prevention and Services Act (FVPSA) 

Technical Assistance (TA) Project to the 

National Resource Center on Domestic 

Violence to support training and 

technical assistance activities. 

SUMMARY: The Administration for 

Children and Families (ACF), 

Administration on Children, Youth and 

Families (ACYF), Family and Youth 

Services Bureau (FYSB), Division of 

Family Violence and Prevention 

Services (DFVPS) announces the award 

of $236,000 as a single-source program 

expansion supplement to the National 

Resource Center on Domestic Violence 

in Harrisburg, PA. The grantee, funded 

under the Family Violence Protection 

and Services Act (FVPSA) program, is a 

technical assistance (TA) provider that 

assists FVPSA service providers to build 

the capacity of domestic violence 

programs. 

DATES: The period of support for the 

single-source program expansion 

supplement is September 30, 2014 

through September 29, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Shawndell Dawson, Senior Program 

Specialist, Family Violence Prevention 

and Services Program, 1250 Maryland 

Avenue SW., Suite 8219, Washington, 

DC 20024. Telephone: 202–205–1476; 

Email: Shawndell.Dawson@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Supplemental award funds will support 

the grantee in providing training and 

technical assistance to domestic 

violence service providers. A portion of 

the supplemental award is contributed 

by the Centers for Disease Control (CDC) 

and Prevention’s National Center for 

Injury Prevention and Control (NCIPC), 

Division of Violence Prevention (DVP). 

This award will expand the scope of 

the NRCDV’s technical assistance 

activities to include additional activities 

concerning the prevention of intimate 

partner violence (IPV) by: (1) 

Coordinating engagement with nationallevel partners, including foundations, 

for the purpose of enhancing 

communication related to IPV 

prevention; 2) engaging in planning to 

facilitate dialogue that will include the 

sharing of tools and lessons learned 

among state domestic violence 

coalitions engaged in IPV primary 

prevention efforts; 3) continuing to 

identify and disseminate information on 

lessons learned and key findings from 

state domestic violence coalitions that 

have implemented IPV primary 

prevention activities through 

www.PreventIPVorg, and other means; 

4) maintaining a virtual workspace to 

assist in the sharing of resources among 

state and territorial domestic violence 

coalitions that are engaged in IPV 

primary prevention activities; and 5) 

facilitating regular, ongoing 

communication between the IPV 

Prevention Council, ACF/DFVPS, and 

CDC/DVP. 

In addition to the prevention 

activities, the grantee will coordinate an 

accessibility and sustainability peer-topeer technical assistance collaborative 

with three to five state domestic 

violence coalitions, which may involve 

activities such as: (1) Identifying state 

coalitions with experience in addressing 

organizational accessibility challenges 

(i.e. mental health, substance use, men, 

and adolescent boys), or sustainability 

challenges (i.e. fiscal management or 

board management); (2) coordinating 

support to domestic violence 

organizations or coalitions experiencing 

accessibility or sustainability 

challenges; and (3) developing peerinformed accessibility and sustainability 

tools and resources, and a discussion 

forum, for use by all domestic violence 

coalitions. 

Statutory Authority: Section 310 of the 

Family Violence Prevention and Services 

Act, as amended by Section 201 of the 

CAPTA Reauthorization Act of 2010, Pub. L. 

111–320. The statutory authority for the 

additional funds from the Centers for Disease 

Control and Prevention is 42 U.S.C. 

247b(k)(2) and 42 USC 280b–1 of the Public 

Health Service Act. 

Christopher Beach, 

Senior Grants Policy Specialist, Division of 

Grants Policy, Office of Administration. 

[FR Doc. 2014–27390 Filed 11–18–14; 8:45 am] 

BILLING CODE 4184–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1855] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request: Experimental 

Studies on Consumer Perceptions of 

Modified Risk Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

Experimental Studies on Consumer 

Perceptions of Modified Risk Tobacco 

Products (MRTPs). 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices 68889 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 20, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

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. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Experimental Studies on Consumer 

Perceptions of Modified Risk Tobacco 

Products—(OMB Control Number 0910– 

NEW) 

FDA’s Center for Tobacco Products 

proposes to conduct experimental 

studies to develop generalizable 

scientific knowledge to help inform its 

implementation of section 911 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 387k), wherein 

FDA will be evaluating information 

submitted to the Agency about how 

consumers understand and perceive 

tobacco products marketed as MRTPs. 

Section 911 of the FD&C Act authorizes 

FDA to grant orders to persons to allow 

the marketing of MRTPs. The term 

‘‘modified risk tobacco product’’ means 

any tobacco product that is sold or 

distributed for use to reduce harm or the 

risk of tobacco-related disease 

associated with commercially marketed 

tobacco products. FDA must issue an 

order authorizing the marketing of an 

MRTP if the Agency determines that the 

product, as it is actually used by 

consumers, will significantly reduce 

harm and the risk of tobacco-related 

disease to individual tobacco users and 

benefit the health of the population as 

a whole taking into account both users 

of tobacco products and persons who do 

not currently use tobacco products 

(section 911(g)(1) of the FD&C Act). 

FDA may also issue an order 

authorizing the marketing of an MRTP 

that reduces or eliminates exposure to a 

harmful substance if, among other 

requirements, the Agency determines 

that the order would be appropriate to 

promote the public health, the issuance 

of the order is expected to benefit the 

population as a whole taking into 

account both users and nonusers of 

tobacco products, and the existing 

evidence demonstrates that a 

measurable and substantial reduction in 

morbidity and mortality among 

individual tobacco users is reasonably 

likely to be shown in subsequent studies 

(section 911(g)(2) of the FD&C Act). In 

addition, section 911 requires that any 

advertising or labeling concerning 

modified risk products enable the 

public to comprehend the information 

concerning modified risk and to 

understand the relative significance of 

such information in the context of total 

health and in relation to all of the 

diseases and health related conditions 

associated with the use of tobacco 

products (section 911(h)(1) of the FD&C 

Act). The proposed research will inform 

the Agency’s efforts to implement the 

provisions of the FD&C Act related to 

MRTPs. 

FDA proposes to conduct 

experimental studies in order to develop 

generalizable scientific information to 

better understand how consumers 

perceive and understand these products, 

how exposure to claims about modified 

risk or exposure influence intentions to 

try or purchase the product (i.e., 

product adoption), and how individual 

characteristics such as current tobacco 

use and/or brand loyalty might 

influence these outcomes. Moreover, 

information from the experimental 

studies may assist FDA to determine the 

appropriate methods and measures for 

gathering such information from 

consumers. 

The impact of different claims 

pertaining to modified risk or exposure 

on understanding, perceptions, and 

potential product adoption (i.e., 

intention to try) will be evaluated by 

conducting a series of three studies that, 

in turn, will examine: The impact of 

claims about cigarette (Study 1) or 

smokeless tobacco products (Study 2) 

among young adult and adult current, 

former, or never users of tobacco; and 

the impact of claims on adolescents 

currently using, or susceptible to using, 

tobacco (Study 3). All three studies will 

assess individual-level factors that 

might influence the impact of claims on 

consumer responses, including: Brand 

loyalty, tobacco use history and 

behavior, concerns about health risks, 

and openness to new products. 

Across all studies, participants will be 

randomized to either see modified risk 

claims or not (control condition). In 

Studies 1 and 2, modified risk claims 

will be displayed on mock tobacco 

product packages and ads. For ethical 

reasons, adolescents (Study 3) will see 

modified risk claims displayed as 

statements alone, not attached to 

product packaging or ads. Consumer 

reactions to claims will be evaluated by 

measuring constructs such as: 

Comprehension of the modified risk 

information in the claims, perceived 

benefits of the product, perceptions of 

harm and risk, misbeliefs about the 

product, quit intentions, and 

willingness to try or purchase the 

product. 

FDA estimates the burden of this 

collection of information as follows: 

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68890 Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Adult Screener ..................................................... 24,000 1 24,000 0.03 (2 minutes) ............ 720 

Study 1 (Adults) ................................................... 1,800 1 1,800 0.333 (20 minutes) ........ 599 

Study 2 (Adults) ................................................... 600 1 600 0.333 (20 minutes) ........ 200 

Total adult hours ........................................... ........................ ........................ ........................ ....................................... 1,519 

Youth Screener .................................................... 6,000 1 6,000 0.03 (2 minutes) ............ 180 

Study 3 (Youth) .................................................... 600 1 600 0.333 (20 minutes) ........ 200 

Total youth hours .......................................... ........................ ........................ ........................ ....................................... 380 

Total Hours ............................................ ........................ ........................ ........................ ....................................... 1,899 

FDA’s burden estimate is based on 

prior experience with research that is 

similar to this proposed study. 

Approximately 30,000 respondents will 

complete a screener to determine 

eligibility for participation in a study, 

estimated to take approximately 2 

minutes (0.03 hours), for a total of 900 

hours for screening activities. Three 

thousand respondents will complete a 

full study, estimated to last 20 minutes 

(0.333 hours), for a total of 999 hours for 

completion of both adult studies and 

one youth study. The estimated total 

hour burden of the collection of 

information is 1,899 hours. 

Dated: November 12, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27283 Filed 11–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1840] 

Electronic Study Data Submission; 

Data Standards; Validation Rules for 

Study Data Tabulation Model 

Formatted Studies; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA) Center for Drug 

Evaluation and Research (CDER) is 

announcing the availability of a 

document entitled ‘‘Validation Rules for 

Study Data Tabulation Model (SDTM) 

Formatted Studies.’’ CDER is making 

this document available to improve the 

standardization and quality of clinical 

data submitted to CDER, as well as to 

improve the predictability of data 

quality and usefulness. 

FOR FURTHER INFORMATION CONTACT: 

Office of Strategic Programs, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1192, 

Silver Spring, MD 20993, email: edata@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: CDER 

supports the regulatory submission of 

standardized clinical study data based 

on the Clinical Data Interchange 

Standards Consortium SDTM. Upon 

receipt of the data, CDER validates the 

data using a set of validation rules. The 

‘‘Validation Rules for SDTM Formatted 

Studies’’ is an Excel file that provides a 

human readable description of a rule set 

for validation. Submitters of clinical 

study data can use this information to 

understand how FDA validates the data. 

The file is available on FDA’s Study 

Data Standards Resources Web page at 

http://www.fda.gov/ForIndustry/

DataStandards/StudyDataStandards/

default.htm. It contains a combination 

of conformance rules (i.e., how well the 

data conform to the standard) and 

business rules (i.e., quality checks; how 

well the data may support useful 

analysis). The rules may be updated 

periodically as new or updated 

validation rules are developed. The 

Change History tab will provide a 

descriptive change history of the 

document. 

Dated: November 14, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–27384 Filed 11–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–1120] 

Vaginal Microbicides: Development for 

the Prevention of Human 

Immunodeficiency Virus Infection; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Vaginal Microbicides: 

Development for the Prevention of HIV 

Infection.’’ The purpose of this guidance 

is to assist sponsors in all phases of 

development of vaginal microbicides, 

defined as vaginal drug products that 

prevent human immunodeficiency virus 

(HIV) acquisition. The guidance outlines 

the types of nonclinical studies and 

clinical trials recommended throughout 

the drug development process to 

support approval of vaginal 

microbicides. This guidance finalizes 

the draft guidance issued on November 

23, 2012. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

mstockstill on DSK4VPTVN1PROD with NOTICES