Proposed Data Collections Submitted for Public Comment and Recommendations, 65325-65326 [2013-25861]

Download as PDF 65325 Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / 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. 2013–25799 Filed 10–30–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES ways to enhance the quality, utility, and clarity of the information to be collected; and (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. Written comments should be received within 60 days of this notice. Proposed Project Centers for Disease Control and Prevention [60Day-14–0879] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–7570 or send comments to LeRoy Richardson, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. 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) Surveys of State, Tribal, Local, and Territorial (STLT) Governmental Agencies (OMB Control No. 0920–0879, Exp. 3/31/2013)—Revision—Office of the Director, Office for State, Tribal Local and Territorial Support (OSTLTS), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC’s mission is to create the expertise, information, and tools that people and communities need to protect their health—through health promotion, prevention of disease, injury and disability, and preparedness for new health threats. CDC seeks to accomplish its mission by collaborating with partners throughout the nation and the world to: Monitor health, detect and investigate health problems, conduct research to enhance prevention, develop and advocate sound public health policies, implement prevention strategies, promote healthy behaviors, foster safe and healthful environments, and provide leadership and training. CDC is requesting a three-year approval for a generic clearance to collect information related to domestic public health issues and services that affect and/or involve state, tribal, local and territorial (STLT) government entities. The respondent universe is comprised of STLT governmental staff or delegates acting on behalf of a STLT agency involved in the provision of essential public health services in the United States. Delegate is defined as a governmental or non-governmental agent (agency, function, office or individual) acting for a principal or submitted by another to represent or act on their behalf. The STLT agency is represented by a STLT entity or delegate with a task to protect and/or improve the public’s health. Information will be used to assess situational awareness of current public health emergencies; make decisions that affect planning, response and recovery activities of subsequent emergencies; fill CDC gaps in knowledge of programs and/or STLT governments that will strengthen surveillance, epidemiology, and laboratory science; improve CDC’s support and technical assistance to states and communities. CDC will conduct brief data collections, across a range of public health topics related to essential public health services. CDC estimates up to 30 data collections with STLT governmental staff or delegates, and 10 data collections with local/county/city governmental staff or delegates will be conducted on an annual basis. Ninetyfive percent of these data collections will be web-based and five percent telephone, in-person, and focus groups. The total annualized burden of 54,000 hours is based on the following estimates. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of surveys per respondent type Average burden per respondent (in hours) Total burden hours (annual) Form name State, Territorial, or Tribal government staff or delegate. Local/County/City government staff or delegate. Web, telephone, in-person, focus group. Web, telephone, in-person, focus group. 800 30 1 24,000 3,000 10 1 30,000 Total ........................................... mstockstill on DSK4VPTVN1PROD with NOTICES Type of respondent ........................................................... ........................ ........................ ........................ 54,000 VerDate Mar<15>2010 19:21 Oct 30, 2013 Jkt 232001 PO 00000 Frm 00062 Fmt 4703 Sfmt 9990 E:\FR\FM\31OCN1.SGM 31OCN1 65326 Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / 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. 2013–25861 Filed 10–30–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1151] Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 research entitled, ‘‘Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at Adolescents.’’ This study is designed to examine how adolescents interpret DTC advertising directed at them. SUMMARY: Submit written or electronic comments on the collection of information by December 30, 2013. ADDRESSES: Submit electronic comments on the collection of information to https:// 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 Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the mstockstill on DSK4VPTVN1PROD with NOTICES DATES: VerDate Mar<15>2010 19:21 Oct 30, 2013 Jkt 232001 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 Study of Direct-toConsumer (DTC) Promotion Directed at Adolescents—(0910—NEW) Regulatory Background Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. Adolescents and DTC Sponsors for several prescription drug classes market their products directly to vulnerable groups, including adolescents. Such DTC marketing to adolescents raises a variety of potential concerns. Adolescents are a unique audience for DTC drug marketing because their cognitive abilities are different than those of adults, and they are usually dependent on adults for health insurance coverage, health care PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 provider access, and prescription drug payment. Despite this uniqueness, research regarding how adolescents use risk and benefit information for healthrelated decisions is limited. If considered at all in healthcare communication research, age is typically treated as simply another segment of the audience (Ref. 1), and researchers fail to consider how information processing (how people understand information) in response to ad exposure might differ among adolescents versus older viewers. The FD&C Act requires manufacturers, packers, and distributors that advertise prescription drugs to disclose certain information about a product’s uses and risks to potential consumers in all advertisements. Consumers must consider tradeoffs with regard to the product’s risks and benefits in deciding whether to ask their health care professionals about the product. Presenting technically factual information is important, but other factors can also affect potential consumers. Information processing capacity, the relevance and vividness of the information, and contextual factors such as family dynamics likely affect how adolescent consumers weigh the potential risks and benefits of using a product. Despite the lack of previous research specific to DTC drug marketing to adolescents, existing theoretical and empirical data make a strong case for treating adolescence as a unique life stage during which vulnerabilities that can affect informed decision-making must be taken into account. Well-known theories of adolescent development have long pointed to developmental changes that occur during the transitional period as an individual moves from childhood to young adulthood (Ref. 2). For instance, Erikson (Refs. 3, 4) describes an often turbulent psychosocial crisis that occurs as adolescents strive to develop their unique identify. Piaget (Refs. 5, 6) and Kohlberg (Ref. 7) describe changes in stages relative to cognitive processing and reasoning that occur in this period, as the adolescent becomes increasingly capable of more abstract thinking. Different cognitive, social and emotional, and developmental processes in the adolescent brain mature simultaneously and at different rates, affecting decision-making by age. All of these factors can influence how adolescents perceive and process information as well as weigh risks and benefits. The need for understanding how adolescents weigh risks and benefits is particularly critical given the potential E:\FR\FM\31OCN1.SGM 31OCN1

Agencies

[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65325-65326]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25861]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-0879]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to LeRoy Richardson, 1600 Clifton Road, MS-D74, Atlanta, 
GA 30333 or send an email to omb@cdc.gov.
    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; and (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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Surveys of State, Tribal, Local, and Territorial (STLT) 
Governmental Agencies (OMB Control No. 0920-0879, Exp. 3/31/2013)--
Revision--Office of the Director, Office for State, Tribal Local and 
Territorial Support (OSTLTS), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    CDC's mission is to create the expertise, information, and tools 
that people and communities need to protect their health--through 
health promotion, prevention of disease, injury and disability, and 
preparedness for new health threats. CDC seeks to accomplish its 
mission by collaborating with partners throughout the nation and the 
world to: Monitor health, detect and investigate health problems, 
conduct research to enhance prevention, develop and advocate sound 
public health policies, implement prevention strategies, promote 
healthy behaviors, foster safe and healthful environments, and provide 
leadership and training.
    CDC is requesting a three-year approval for a generic clearance to 
collect information related to domestic public health issues and 
services that affect and/or involve state, tribal, local and 
territorial (STLT) government entities. The respondent universe is 
comprised of STLT governmental staff or delegates acting on behalf of a 
STLT agency involved in the provision of essential public health 
services in the United States. Delegate is defined as a governmental or 
non-governmental agent (agency, function, office or individual) acting 
for a principal or submitted by another to represent or act on their 
behalf. The STLT agency is represented by a STLT entity or delegate 
with a task to protect and/or improve the public's health. Information 
will be used to assess situational awareness of current public health 
emergencies; make decisions that affect planning, response and recovery 
activities of subsequent emergencies; fill CDC gaps in knowledge of 
programs and/or STLT governments that will strengthen surveillance, 
epidemiology, and laboratory science; improve CDC's support and 
technical assistance to states and communities. CDC will conduct brief 
data collections, across a range of public health topics related to 
essential public health services.
    CDC estimates up to 30 data collections with STLT governmental 
staff or delegates, and 10 data collections with local/county/city 
governmental staff or delegates will be conducted on an annual basis. 
Ninety-five percent of these data collections will be web-based and 
five percent telephone, in-person, and focus groups. The total 
annualized burden of 54,000 hours is based on the following estimates.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average
                                                     Number of      surveys per     burden per     Total burden
      Type of respondent            Form name       respondents     respondent      respondent         hours
                                                                       type         (in hours)       (annual)
----------------------------------------------------------------------------------------------------------------
State, Territorial, or Tribal   Web, telephone,              800              30               1          24,000
 government staff or delegate.   in-person,
                                 focus group.
Local/County/City government    Web, telephone,            3,000              10               1          30,000
 staff or delegate.              in-person,
                                 focus group.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          54,000
----------------------------------------------------------------------------------------------------------------



[[Page 65326]]

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. 2013-25861 Filed 10-30-13; 8:45 am]
BILLING CODE 4163-18-P