Agency Forms Undergoing Paperwork Reduction Act Review, 43202-43203 [2016-15645]

Download as PDF 43202 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices acquisitions. The provision is among the representations and certifications that are available for completion in the System for Award Management (SAM). B. Annual Reporting Burden Respondents: 397,000. Responses per Respondent: 1.46. Total Responses: 579,620. Hours per Response: .500. Total Burden Hours: 289,810. Frequency: On Occasion. Affected Public: Businesses or other for-profit and not-for-profit institutions. C. Public Comments Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202–501–4755. Please cite OMB Control No. 9000– 0136 regarding Commercial Item Acquisitions in all correspondence. Dated: June 28, 2016. Mahruba Uddowla, Acting Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. Proposed Project National Amyotrophic Lateral Sclerosis (ALS) Registry—Revision—Agency for Toxic Substances and Disease Registry (ATSDR) [FR Doc. 2016–15703 Filed 6–30–16; 8:45 am] BILLING CODE 6820–EP–P DEPARTMENT OF HEALTH AND HUMAN SERVICES asabaliauskas on DSK3SPTVN1PROD with NOTICES Agency for Toxic Substances and Disease Registry [30Day–16–0041] Agency Forms Undergoing Paperwork Reduction Act Review The Agency for Toxic Substances and Disease Registry (ATSDR) has submitted the following information collection request to the Office of Management and VerDate Sep<11>2014 19:05 Jun 30, 2016 Jkt 238001 Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: 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. Background and Brief Description On October 10, 2008, President Bush signed S. 1382: ALS Registry Act which amended the Public Health Service Act to provide for the establishment of an Amyotrophic Lateral Sclerosis (ALS) Registry. The activities described are part of the ongoing effort to maintain the National ALS Registry. First approved in 2010 for selfregistration, the primary goal of the surveillance system/registry remains to obtain reliable information on the incidence and prevalence of ALS and to better describe the demographic characteristics (age, race, sex, and PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 geographic location) of persons with ALS (PALS). Those interested in participating in the National ALS Registry must answer a series of validation questions and if determined to be eligible they can register. The secondary goal of the surveillance system/registry is to collect additional information on potential risk factors for ALS, including, but not limited to, family history of ALS, smoking history, military service, residential history, lifetime occupational exposure, home pesticide use, hobbies, hormonal and reproductive history (women only), caffeine use, trauma, health insurance, open-ended supplemental questions, and clinical signs and symptoms. After registration, participants complete as many as 16 voluntary survey modules, each taking five minutes (maximum 80 minutes). In addition, in Year 1, a disease progression survey for new registrants is completed at 0, 3, and 6 months. In Years 2 and 3, the disease progression survey is repeated at the yearly anniversary and at 6 months. For burden estimation, the number of disease progression survey responses per year has been rounded up to 3 times. A biorepository component is being added to increase the value of the National ALS Registry to researchers. As part of registration the participant can request additional information about the biorepository and provide additional contact information. A geographically representative sample will be selected to provide specimens. There are two types of specimen collections, in-home and postmortem. The in-home collection includes blood, urine, hair and nails. The postmortem collection includes the brain, spinal cord, cerebral spinal fluid (CSF), bone, muscle, and skin. In addition to fulfilling the two-part Congressional mandate, the Registry is designed to be a tool for ALS researchers. Now that the Registry has matured, ATSDR will make data and specimens available to researchers. They can request access to specimens, data, or both collected by the National ALS Registry for their research projects. ATSDR will review applications for scientific validity and human subjects protection and make data/specimens available to approved researchers. ATSDR is also collaborating with ALS service organizations to conduct outreach activities through their local chapters and districts as well as on a national level. They will provide ATSDR with information on their outreach efforts in support of the Registry on a monthly basis. There are no costs to the respondents other than their time. The total number E:\FR\FM\01JYN1.SGM 01JYN1 43203 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices of burden hours requested is 1,824 hours. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name Person with ALS ..................... ALS Case Validation Questions ............................................. ALS Case Registration Form ................................................. Voluntary Survey Modules ..................................................... Disease Progression Survey .................................................. ALS Biorepository Specimen Processing Form ..................... ALS Registry Research Application Form ............................. Annual Update ........................................................................ Chapter/District Outreach Reporting Form ............................ National Office Outreach Reporting Form ............................. Researchers ............................ ALS Service Organization ...... Jeffrey M. Zirger, Health Scientist, Acting 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. 2016–15645 Filed 6–30–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–16–0457: Docket No. CDC–206– 0058] Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: 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 Aggregate Reports for Tuberculosis Program Evaluation. The goal of the study is to allow CDC to collect and monitor indicators for key program activities, such as finding tuberculosis infections in recent contacts of cases and in other persons likely to be infected and providing therapy for latent tuberculosis infection in an effort to eliminate Tuberculosis in the United States. asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:05 Jun 30, 2016 Jkt 238001 Written comments must be received on or before August 30, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC–2016– 0058 by any of the following methods: • Federal eRulemaking Portal: Regulations.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. DATES: 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. 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 FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 1,670 1,500 750 750 325 36 24 135 2 Number of responses per respondent 1 1 1 3 1 1 1 12 12 Average burden per response (in hours) 2/60 10/60 80/60 5/60 30/60 30/60 15/60 5/60 20/60 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) 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. E:\FR\FM\01JYN1.SGM 01JYN1

Agencies

[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43202-43203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15645]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-16-0041]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Agency for Toxic Substances and Disease Registry (ATSDR) has 
submitted the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to omb@cdc.gov. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: 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

National Amyotrophic Lateral Sclerosis (ALS) Registry--Revision--Agency 
for Toxic Substances and Disease Registry (ATSDR)

Background and Brief Description

    On October 10, 2008, President Bush signed S. 1382: ALS Registry 
Act which amended the Public Health Service Act to provide for the 
establishment of an Amyotrophic Lateral Sclerosis (ALS) Registry. The 
activities described are part of the ongoing effort to maintain the 
National ALS Registry.
    First approved in 2010 for self-registration, the primary goal of 
the surveillance system/registry remains to obtain reliable information 
on the incidence and prevalence of ALS and to better describe the 
demographic characteristics (age, race, sex, and geographic location) 
of persons with ALS (PALS). Those interested in participating in the 
National ALS Registry must answer a series of validation questions and 
if determined to be eligible they can register.
    The secondary goal of the surveillance system/registry is to 
collect additional information on potential risk factors for ALS, 
including, but not limited to, family history of ALS, smoking history, 
military service, residential history, life-time occupational exposure, 
home pesticide use, hobbies, hormonal and reproductive history (women 
only), caffeine use, trauma, health insurance, open-ended supplemental 
questions, and clinical signs and symptoms. After registration, 
participants complete as many as 16 voluntary survey modules, each 
taking five minutes (maximum 80 minutes). In addition, in Year 1, a 
disease progression survey for new registrants is completed at 0, 3, 
and 6 months. In Years 2 and 3, the disease progression survey is 
repeated at the yearly anniversary and at 6 months. For burden 
estimation, the number of disease progression survey responses per year 
has been rounded up to 3 times.
    A biorepository component is being added to increase the value of 
the National ALS Registry to researchers. As part of registration the 
participant can request additional information about the biorepository 
and provide additional contact information. A geographically 
representative sample will be selected to provide specimens. There are 
two types of specimen collections, in-home and postmortem. The in-home 
collection includes blood, urine, hair and nails. The postmortem 
collection includes the brain, spinal cord, cerebral spinal fluid 
(CSF), bone, muscle, and skin.
    In addition to fulfilling the two-part Congressional mandate, the 
Registry is designed to be a tool for ALS researchers. Now that the 
Registry has matured, ATSDR will make data and specimens available to 
researchers. They can request access to specimens, data, or both 
collected by the National ALS Registry for their research projects. 
ATSDR will review applications for scientific validity and human 
subjects protection and make data/specimens available to approved 
researchers.
    ATSDR is also collaborating with ALS service organizations to 
conduct outreach activities through their local chapters and districts 
as well as on a national level. They will provide ATSDR with 
information on their outreach efforts in support of the Registry on a 
monthly basis.
    There are no costs to the respondents other than their time. The 
total number

[[Page 43203]]

of burden hours requested is 1,824 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form name             respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Person with ALS....................  ALS Case Validation                   1,670               1            2/60
                                      Questions.
                                     ALS Case Registration Form.           1,500               1           10/60
                                     Voluntary Survey Modules...             750               1           80/60
                                     Disease Progression Survey.             750               3            5/60
                                     ALS Biorepository Specimen              325               1           30/60
                                      Processing Form.
Researchers........................  ALS Registry Research                    36               1           30/60
                                      Application Form.
                                     Annual Update..............              24               1           15/60
ALS Service Organization...........  Chapter/District Outreach               135              12            5/60
                                      Reporting Form.
                                     National Office Outreach                  2              12           20/60
                                      Reporting Form.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Health Scientist, Acting 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. 2016-15645 Filed 6-30-16; 8:45 am]
 BILLING CODE 4163-18-P