Agency Forms Undergoing Paperwork Reduction Act Review, 62907-62908 [2016-21922]

Download as PDF Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices recommendations for Congress and the President for commemorating the centennial of World War I. The Commission does not have an appropriation and operated solely on donated funds. Agenda: Friday September 30, 2016 Old Business • Acceptance of minutes of last meeting • Public Comment Period New Business • Executive Director’s Report—Mr. Dayton • Approval of United States Foundation Relationship Memo • Approval of Budget Request for Foundation • Memorial Report—Mr. Fountain • Education Report—Dr. O’Connell • Endorsements—(RFS)—Dr. Seefried • International Report—Dr. Seefried • Report on April 6 Event—Drs. Seefried and Naylor • Other Business • Chairman’s Report • Set Next Meeting • Motion to Adjourn BILLING CODE 6820–95–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–16–16BBS] Proposed Data Collection Submitted for Public Comment and Recommendations—Airline and Traveler Information Collection: Domestic Manifests and the Passenger Locator Form; Correction Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice; Correction. AGENCY: The Centers for Disease Control and Prevention (CDC) published a document in the Federal Register of September 2, 2016, concerning request for comments on Proposed Data Collection Submitted for Public Comment and Recommendations— Airline and Traveler Information Collection: Domestic Manifests and the Passenger Locator Form. The document provided the incorrect docket number (CDC–2016–0088). Lhorne on DSK30JT082PROD with NOTICES 15:27 Sep 12, 2016 Jkt 238001 Correction In the Federal Register of September 2, 2016, in FR Doc. 2016–21103, on page 60702, in the second column (second and third paragraphs), correct the Docket No. to read: CDC–2016–0086 Dated: September 9, 2016. 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. 2016–21923 Filed 9–12–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Agency Forms Undergoing Paperwork Reduction Act Review [FR Doc. 2016–21901 Filed 9–12–16; 8:45 am] VerDate Sep<11>2014 Leroy Richardson, 1600 Clifton Road, MS D–74, Atlanta, GA 30333; telephone (404) 639–4965; email: omb@cdc.gov. [30Day–16–1005] Dated: September 7, 2016. Daniel S. Dayton, Designated Federal Official, World War I Centennial Commission. SUMMARY: FOR FURTHER INFORMATION CONTACT: The Centers for Disease Control and Prevention (CDC) 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 62907 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. Written comments and/or suggestions regarding the items contained in this notice should be directed 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 Older Adult Safe Mobility Assessment Tool (OMB Control No. 0920–1005, Expiration Date: 10/31/2016)— Extension—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention (CDC) is seeking OMB approval to extend the previously approved information collection project under OMB Control Number 0920–1005 to evaluate the Mobility Planning Tool (MPT). Within the Injury Center, preventing falls and ensuring safe transportation for older adults are strategic priorities. The purposes of this information collection is to evaluate whether the Mobility Planning Tool is effective for promoting readiness to adopt mobility-protective behaviors in older adults and to assess potential strategies for dissemination of the MPT. The study population is communityliving older adults ages 60–74 with no known mobility limitations. Effectiveness of the tool will be assessed using two different comparisons: (1) A comparison between individuals’ attitudes and behaviors related to protecting their mobility as they age before and after receiving the MPT in the group that received the MPT, and (2) a comparison of both mobility-related attitudes and behaviors and changes between the group that received the MPT and the group that did not receive the MPT. Study findings will be used to identify areas of the MPT that may need revision before it is disseminated publicly. There are no costs to respondents other than their time. The total estimated annual burden hours are 367. E:\FR\FM\13SEN1.SGM 13SEN1 62908 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Type of respondents Form name Individuals Responding to Initial Phone Call Who Refuse to be Screened. Individuals Responding to Initial Phone Call Responding to Screening Questions. Study Participants ........................................... Study Participants ........................................... Study Participants ........................................... Screening Interview Guide ............................. 1,250 1 1/60 Screening Interview Guide ............................. 750 1 5/60 Baseline Interview Guide ............................... MPT ................................................................ Follow-up Interview Guide ............................. 500 250 450 1 1 1 10/60 30/60 10/60 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. 2016–21922 Filed 9–12–16; 8:45 am] BILLING CODE 4163–18–P Food and Drug Administration [Docket No. FDA–2015–D–2244] Qualification of Biomarker—Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease; Guidance for Industry; Availability Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ‘‘Qualification of Biomarker—Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease.’’ This guidance provides a qualified context of use (COU) for plasma fibrinogen in interventional clinical trials of chronic obstructive pulmonary disease (COPD) subjects at high risk for exacerbations and/or all-cause mortality. This guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER Lhorne on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:27 Sep 12, 2016 Jkt 238001 Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comment as follows: DATES: Electronic Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: review group reconsidering and reconfirming the suitability of the biomarker. Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/ paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–D–2244 for ‘‘Qualification for the Use of Plasma Fibrinogen in Studies Examining Exacerbations and/or AllCause Mortality for Patients with Chronic Obstructive Pulmonary Disease; Availability.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62907-62908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21922]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-1005]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) 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. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed 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

    Older Adult Safe Mobility Assessment Tool (OMB Control No. 0920-
1005, Expiration Date: 10/31/2016)--Extension--National Center for 
Injury Prevention and Control (NCIPC), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC) is seeking OMB 
approval to extend the previously approved information collection 
project under OMB Control Number 0920-1005 to evaluate the Mobility 
Planning Tool (MPT).
    Within the Injury Center, preventing falls and ensuring safe 
transportation for older adults are strategic priorities. The purposes 
of this information collection is to evaluate whether the Mobility 
Planning Tool is effective for promoting readiness to adopt mobility-
protective behaviors in older adults and to assess potential strategies 
for dissemination of the MPT.
    The study population is community-living older adults ages 60-74 
with no known mobility limitations. Effectiveness of the tool will be 
assessed using two different comparisons: (1) A comparison between 
individuals' attitudes and behaviors related to protecting their 
mobility as they age before and after receiving the MPT in the group 
that received the MPT, and (2) a comparison of both mobility-related 
attitudes and behaviors and changes between the group that received the 
MPT and the group that did not receive the MPT.
    Study findings will be used to identify areas of the MPT that may 
need revision before it is disseminated publicly.
    There are no costs to respondents other than their time. The total 
estimated annual burden hours are 367.

[[Page 62908]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                    Number of       Number of       burden per
         Type of respondents                   Form name           respondents    responses per    response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Individuals Responding to Initial      Screening Interview                1,250               1             1/60
 Phone Call Who Refuse to be Screened.  Guide.
Individuals Responding to Initial      Screening Interview                  750               1             5/60
 Phone Call Responding to Screening     Guide.
 Questions.
Study Participants...................  Baseline Interview Guide             500               1            10/60
Study Participants...................  MPT.....................             250               1            30/60
Study Participants...................  Follow-up Interview                  450               1            10/60
                                        Guide.
----------------------------------------------------------------------------------------------------------------


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. 2016-21922 Filed 9-12-16; 8:45 am]
 BILLING CODE 4163-18-P