Agency Forms Undergoing Paperwork Reduction Act Review, 35272-35273 [2013-13899]

Download as PDF 35272 Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Notices GENERAL SERVICES ADMINISTRATION [Notice-MK–2013–05; Docket No. 2013– 0002; Sequence 20] The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting Office of Government-wide Policy, U.S. General Services Administration (GSA). ACTION: Meeting notice. AGENCY: SUMMARY: The Presidential Commission on Election Administration (PCEA), a Federal Advisory Committee established in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C., App., and Executive Order 13639, as amended by EO 13644, will hold a meeting open to the public on Friday, June 28, 2013. DATES: Effective date: June 12, 2013. Meeting date: The meeting will be held on Friday, June 28, 2013, beginning at 9:00 a.m. eastern time, ending no later than 5:00 p.m. FOR FURTHER INFORMATION CONTACT: Mr. Mark Nejbauer, Designated Federal Officer, President’s Commission on Election Administration, GSA, 1776 G Street NW., Washington, DC 20006, email mark.nejbauer@supportthevoter.gov. mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Background: The PCEA was established to identify best practices and make recommendations to the President on the efficient administration of elections in order to ensure that all eligible voters have the opportunity to cast their ballots without undue delay, and to improve the experience of voters facing other obstacles in casting their ballots. Agenda: The purpose of this meeting is for the PCEA to receive information to assist its members in collecting information and data relevant to its deliberations on the subjects set forth in Executive Order 13639, as amended. The agenda will be as follows: • Introductions & Statement of Plan for The Meeting • Testimony by local, county and state election officials • Receipt of reports by experts in some of the subject areas detailed in Executive Order 13639 • Comments by interested members of the public Meeting Access: The PCEA will convene its meeting in the David W. Dyer U.S. Courthouse, 300 Northeast 1st Avenue, Miami, Florida 33132. This site is accessible to individuals with disabilities. The meeting may also be VerDate Mar<15>2010 16:32 Jun 11, 2013 Jkt 229001 Webcast or made available via audio link. Please refer to PCEA’s Web site, https://www.supportthevoter.gov, for the most up-to-date meeting agenda and access information. Attendance at the Meeting: Individuals interested in attending the meeting must register in advance because of limited space. Please contact Mr. Nejbauer at the email address above to register to attend this meeting and obtain meeting materials. Materials may also be accessed online at https:// www.supportthevoter.gov. To attend this meeting, please submit your full name, organization, email address, and phone number to Mark Nejbauer by 5:00 p.m. eastern standard time on Tuesday, June 25, 2013. Detailed meeting minutes will be posted within 90 days of the meeting. Procedures for Providing Public Comments: In general, public comments will be posted on the PCEA Web site (see above). All comments, including attachments and other supporting materials, received are part of the public record and subject to public disclosure. Any comments submitted in connection with the PCEA meeting will be made available to the public under the provisions of the Federal Advisory Committee Act. Contact Mark Nejbauer at mark.nejbauer@supportthevoter.gov to register to comment during the meeting’s public comment period. Registered speakers/organizations will be allowed a maximum of 3 minutes each due to limited time for individual comments. Written copies providing expanded explanations of oral presentations are encouraged. Requests to comment at the meeting must be received by 5:00 p.m. eastern standard time on Tuesday, June 25, 2013. The public is invited to submit written comments for this meeting until 5:00 p.m. eastern time on Tuesday, June 25, 2013, by either of the following method: Electronic or Paper Statements: Submit electronic statements to Mr. Nejbauer, Designated Federal Officer at mark.nejbauer@supportthevoter.gov; or send three (3) copies of any written statements to Mr. Nejbauer at the PCEA GSA address above. Written comments not received by 5:00 p.m. eastern time on June 25, 2013 may be submitted but will not be considered at the June 28, 2013 meeting. Dated: June 7, 2013. Laura Auletta, Acting Associate Administrator, Office of Government-wide Policy, General Services Administration. [FR Doc. 2013–13959 Filed 6–11–13; 8:45 am] BILLING CODE 6820–14–P PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30-Day–13–13LD] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 639-7570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project Formative Research, Messages and Materials Development for NCBDDD— NEW—Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities (NCBDDD). Background and Brief Description The Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities (NCBDDD), requests approval for a new generic information collection package that supports formative research in birth defects and developmental disabilities; human development and disabilities, and blood disorders. Identified priority diseases, disorders, and conditions included in this information collection activity include but are not limited to preconception health; autism spectrum disorders (ASDs) and other developmental disabilities; fetal alcohol spectrum disorders (FASDs); neural tube defects (spina bifida, anencephaly); muscular dystrophy; fragile X; deep vein thrombosis/pulmonary embolism (DVT/PE); sickle cell disease (SCD); attention-deficit/hyperactivity disorder (ADHD); and Tourette syndrome. Birth defects affect 1 in 33 babies and are a leading cause of infant death in the United States. More than 5,500 infants die each year due to birth defects. Additionally, over 500,000 children are diagnosed with a developmental disability. With more information, the causes of these birth defects and developmental disabilities can be identified and action can be taken to protect children and to develop new E:\FR\FM\12JNN1.SGM 12JNN1 35273 Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Notices ways to help women have healthy babies. The behavioral, clinical, and surveillance projects implemented by NCBDDD are the foundation upon which recommendations and guidelines are revised and updated. Formative research is the mechanism by which evidence is obtained for priority diseases in these three (3) health condition groups and by which recommendations and guidelines are revised and updated. NCBDDD conducts formative research for developing new messages, materials, and strategies that respond to the changing epidemiology of these priority health conditions. A generic clearance mechanism would increase productivity of CDC programs and improve the quality of public health interventions and health communication programs. Targeted audience members or representatives provide the information for developing clear and influential health messages, materials, and strategies that promote health and wellbeing. An integrated research effort is needed to fill in gaps of knowledge, awareness, screening, and prevention behaviors and could simultaneously work to reduce stigma surrounding these topics within special populations, explore cultural issues, and increase the demand for, and uptake of screening by health care providers. Overall, these formative research activities are intended to provide information that will increase the success of the surveillance or research project through increasing response rates and decreasing response error thereby decreasing future data collection burden to the public. It is estimated that approximately 8— 10 individual projects will be processed each year using this mechanism. Data collection activities from a variety of groups are anticipated. Primary respondents will be Latina Spanishdominant women of childbearing age (ages 18–45, both childless adult women and parents of young children) and individuals who identify as a member of a specified racial/ethnic/cultural minority community and thus considered hard to reach. Members of the educational, research, and public health community may also be targeted for their subject matter expertise. This request is submitted to obtain Office of Management and Budget (OMB) clearance for three years. The estimates of annualized burden hours are based on past experience with recruitment and the administration of similar surveys and focus groups. It is estimated that 26,800 respondents will have to be screened annually to recruit the appropriate number of respondents for this data collection activity. Depending on the individual information collection request, information might be collected using the following modes: focus groups, inperson interviews (face-to-face or via telephone, paper-and-pencil questionnaires, or electronically. Electronic modes include handheld devices, computer-assisted selfinterviews, computer-assisted personal interviews, web-based surveys, or other point-of-service collection devices. Specific information will be provided with each individual project submission. The estimated annualized burden hours for this data collection activity are 16,550. There is no cost to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent General General General General public public public public and and and and health health health health care care care care providers providers providers providers ............................... ............................... ............................... ............................... Ron A. Otten, Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–13899 Filed 6–11–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on DSK4VPTVN1PROD with NOTICES [Docket No. FDA–2013–N–0578] Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567 AGENCY: Food and Drug Administration, HHS. VerDate Mar<15>2010 16:32 Jun 11, 2013 Jkt 229001 Number of respondents Form name ACTION: Screener ................................ Consent Forms ...................... Moderator’s Guide ................. Surveys .................................. Notice. Submit either electronic or written comments on the collection of information by August 12, 2013. DATES: Frm 00035 Fmt 4703 Sfmt 4703 Average hours per response 1 1 1 1 10/60 5/60 1 15/60 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: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301–796–7726, Ila.Mizrachi@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 ADDRESSES: 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information relating to general licensing provisions for biologics license applications (BLAs), changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Forms FDA 356h and 2567. PO 00000 26,800 10,000 10,000 5,000 Number of responses per respondent E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Pages 35272-35273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13899]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-13-13LD]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC 
20503 or by fax to (202) 395-5806. Written comments should be received 
within 30 days of this notice.

Proposed Project

    Formative Research, Messages and Materials Development for NCBDDD--
NEW--Centers for Disease Control and Prevention (CDC), National Center 
on Birth Defects and Developmental Disabilities (NCBDDD).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), National 
Center on Birth Defects and Developmental Disabilities (NCBDDD), 
requests approval for a new generic information collection package that 
supports formative research in birth defects and developmental 
disabilities; human development and disabilities, and blood disorders. 
Identified priority diseases, disorders, and conditions included in 
this information collection activity include but are not limited to 
preconception health; autism spectrum disorders (ASDs) and other 
developmental disabilities; fetal alcohol spectrum disorders (FASDs); 
neural tube defects (spina bifida, anencephaly); muscular dystrophy; 
fragile X; deep vein thrombosis/pulmonary embolism (DVT/PE); sickle 
cell disease (SCD); attention-deficit/hyperactivity disorder (ADHD); 
and Tourette syndrome.
    Birth defects affect 1 in 33 babies and are a leading cause of 
infant death in the United States. More than 5,500 infants die each 
year due to birth defects. Additionally, over 500,000 children are 
diagnosed with a developmental disability. With more information, the 
causes of these birth defects and developmental disabilities can be 
identified and action can be taken to protect children and to develop 
new

[[Page 35273]]

ways to help women have healthy babies.
    The behavioral, clinical, and surveillance projects implemented by 
NCBDDD are the foundation upon which recommendations and guidelines are 
revised and updated. Formative research is the mechanism by which 
evidence is obtained for priority diseases in these three (3) health 
condition groups and by which recommendations and guidelines are 
revised and updated.
    NCBDDD conducts formative research for developing new messages, 
materials, and strategies that respond to the changing epidemiology of 
these priority health conditions. A generic clearance mechanism would 
increase productivity of CDC programs and improve the quality of public 
health interventions and health communication programs.
    Targeted audience members or representatives provide the 
information for developing clear and influential health messages, 
materials, and strategies that promote health and well-being. An 
integrated research effort is needed to fill in gaps of knowledge, 
awareness, screening, and prevention behaviors and could simultaneously 
work to reduce stigma surrounding these topics within special 
populations, explore cultural issues, and increase the demand for, and 
uptake of screening by health care providers.
    Overall, these formative research activities are intended to 
provide information that will increase the success of the surveillance 
or research project through increasing response rates and decreasing 
response error thereby decreasing future data collection burden to the 
public.
    It is estimated that approximately 8--10 individual projects will 
be processed each year using this mechanism. Data collection activities 
from a variety of groups are anticipated. Primary respondents will be 
Latina Spanish-dominant women of childbearing age (ages 18-45, both 
childless adult women and parents of young children) and individuals 
who identify as a member of a specified racial/ethnic/cultural minority 
community and thus considered hard to reach. Members of the 
educational, research, and public health community may also be targeted 
for their subject matter expertise.
    This request is submitted to obtain Office of Management and Budget 
(OMB) clearance for three years. The estimates of annualized burden 
hours are based on past experience with recruitment and the 
administration of similar surveys and focus groups. It is estimated 
that 26,800 respondents will have to be screened annually to recruit 
the appropriate number of respondents for this data collection 
activity. Depending on the individual information collection request, 
information might be collected using the following modes: focus groups, 
in-person interviews (face-to-face or via telephone, paper-and-pencil 
questionnaires, or electronically. Electronic modes include handheld 
devices, computer-assisted self-interviews, computer-assisted personal 
interviews, web-based surveys, or other point-of-service collection 
devices.
    Specific information will be provided with each individual project 
submission. The estimated annualized burden hours for this data 
collection activity are 16,550. There is no cost to respondents other 
than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of
          Type of respondent                    Form name            Number of     responses per   Average hours
                                                                    respondents     respondent     per response
----------------------------------------------------------------------------------------------------------------
General public and health care          Screener................          26,800               1           10/60
 providers.
General public and health care          Consent Forms...........          10,000               1            5/60
 providers.
General public and health care          Moderator's Guide.......          10,000               1               1
 providers.
General public and health care          Surveys.................           5,000               1           15/60
 providers.
----------------------------------------------------------------------------------------------------------------


Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2013-13899 Filed 6-11-13; 8:45 am]
BILLING CODE 4163-18-P
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