80 FR 18848 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 67 (April 8, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 67 (April 8, 2015)
| Page Range | 18848-18850 | |
| FR Document | 2015-08028 |
[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)] [Notices] [Pages 18848-18850] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08028] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-15-1005; Docket No. CDC-2015-0018] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: 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 the information collection request for reinstatement with change of the collection previously approved under OMB control number 0920-1005--``Conduct an Older Adult Mobility Assessment Tool Impact Evaluation and Develop a Dissemination Plan''. This collection will help evaluate whether the Mobility Planning Tool is effective for promoting readiness to adopt mobility-protective behaviors in older adults. DATES: Written comments must be received on or before June 8, 2015. ADDRESSES: You may submit comments, identified by Docket No. CDC-2015- 0018 by any of the following methods: Federal eRulemaking Portal: Regulation.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. 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. FOR FURTHER INFORMATION CONTACT: 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: [email protected]. 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 extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the [[Page 18849]] 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. Proposed Project Conduct an Older Adult Mobility Assessment Tool Impact Evaluation and Develop a Dissemination Plan (OMB Control No. 0920-1005)-- Reinstatement with Change--National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC's National Center for Injury Prevention and Control (NCIPC) requests approval for 3 years, from the Office of Management and Budget (OMB) for a reinstatement with change for the previously approved OMB No. 0920-1005 (Exp. Date: 12-31-2014) designed to evaluate whether the Mobility Planning Tool is effective for promoting readiness to adopt mobility-protective behaviors in older adults and assess potential strategies for dissemination of the Mobility Planning Tool. With this reinstatement, NCIPC requests a change of title from ``Older Adult Safe Mobility Assessment Tool'' to ``Conduct an Older Adult Mobility Assessment Tool Impact Evaluation and Develop a Dissemination Plan.'' The population of older adults in the U.S. is growing rapidly. By 2030, this segment of the population will increase to an estimated 72 million (20% of the U.S. population). A critical public health issue for the older adult population is mobility--how well people are able to get to places they need to go. The goals of this study are to evaluate (1) whether the Mobility Planning Tool (MPT) is effective for promoting readiness to adopt mobility-protective behaviors in older adults and (2) assess potential strategies for dissemination of the MPT. NCIPC will collect study data using telephone interviews. The study population is community-living older adults ages 60-74 with no known mobility limitations. A total of 1,000 individuals will participate in the study. Prospective respondents will answer a series of screening questions. Individuals who meet the screening criteria and are willing to participate will complete a baseline and follow-up interview each lasting approximately 10 minutes. NCIPC will analyzed the collected data using descriptive statistics and a series of t-tests, chi-square analyses, and Mann-Whitney U-tests. Multivariate analyses will include a series of repeated measures Analysis of Variance (ANOVA), and logistic regressions. The data collected from this study will help CDC identify what further revisions to the MPT might be necessary before it is disseminated publicly. Selected study findings may eventually be presented in oral and poster presentations and published in a peer- reviewed journal. Without this information collection, CDC will not know whether the MPT is an effective tool for promoting readiness to adopt mobility-protective behaviors in older adults and will not know whether additional revisions to the tool are necessary before the MPT is disseminated publicly. Without this study, CDC will have limited information about what strategies are most likely to be effective for disseminating the MPT publicly to the target audience. The total estimated annual burden hours are 734. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondents Form name respondents responses per response (in (in hours) respondent hours) ---------------------------------------------------------------------------------------------------------------- Individuals Responding to Screening 2,500 1 1/60 42 Initial Phone Call Who Refuse Interview Guide. to be Screened. Individuals Responding to Screening 1,500 1 5/60 125 Initial Phone Call Responding Interview Guide. to Screening Questions. Study Participants............ Baseline 1,000 1 10/60 167 Interview Guide. Study Participants............ MPT............. 500 1 30/60 250 Study Participants............ Follow-up 900 1 10/60 150 Interview Guide. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 734 ---------------------------------------------------------------------------------------------------------------- [[Page 18850]] 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. 2015-08028 Filed 4-7-15; 8:45 am] BILLING CODE 4163-18-P
![18848 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of Avg. burden
Number of Total burden
Type of respondents Form name responses per per response
respondents (in hrs)
respondent (in hrs)
Local Health Department Represent- Interview Guide for Local Health De- 15 1 30/60 8
ative. partment Representative.
Older Adult—Screened Out .............. Senior Village Survey ....................... 1,431 1 1/60 24
Older Adult—Participant ................... Senior Village Survey ....................... 1,550 1 20/60 517
Total ........................................... ........................................................... ........................ ........................ ........................ 580
Leroy A. Richardson, The Director, Management Analysis and readiness to adopt mobility-protective
Chief, Information Collection Review Office, Services Office, has been delegated the behaviors in older adults.
Office of Scientific Integrity, Office of the authority to sign Federal Register DATES: Written comments must be
Associate Director for Science, Office of the notices pertaining to announcements of received on or before June 8, 2015.
Director, Centers for Disease Control and meetings and other committee
Prevention. ADDRESSES: You may submit comments,
management activities, for both the identified by Docket No. CDC–2015–
[FR Doc. 2015–08027 Filed 4–7–15; 8:45 am] Centers for Disease Control and 0018 by any of the following methods:
BILLING CODE 4163–18–P Prevention and the Agency for Toxic Federal eRulemaking Portal:
Substances and Disease Registry. Regulation.gov. Follow the instructions
DEPARTMENT OF HEALTH AND Catherine Ramadei, for submitting comments.
HUMAN SERVICES Acting Director, Management Analysis and Mail: Leroy A. Richardson,
Services Office, Centers for Disease Control Information Collection Review Office,
Centers for Disease Control and and Prevention. Centers for Disease Control and
Prevention [FR Doc. 2015–07997 Filed 4–7–15; 8:45 am] Prevention, 1600 Clifton Road NE., MS–
BILLING CODE 4163–18–P D74, Atlanta, Georgia 30329.
Disease, Disability, and Injury Instructions: All submissions received
Prevention and Control Special must include the agency name and
Emphasis Panel (SEP): Initial Review DEPARTMENT OF HEALTH AND Docket Number. All relevant comments
HUMAN SERVICES received will be posted without change
In accordance with Section 10(a)(2) of
to Regulations.gov, including any
the Federal Advisory Committee Act Centers for Disease Control and personal information provided. For
(Pub. L. 92–463), the Centers for Disease Prevention access to the docket to read background
Control and Prevention (CDC)
documents or comments received, go to
announces a meeting for the initial [60Day–15–1005; Docket No. CDC–2015–
Regulations.gov.
review of applications in response to 0018]
(FOA) DP15–001, Natural Experiments Please note: All public comment should be
of the Impact of Population-targeted Proposed Data Collection Submitted submitted through the Federal eRulemaking
for Public Comment and portal (Regulations.gov) or by U.S. mail to the
Health Policies to Prevent Diabetes and
Recommendations address listed above.
its Complications.
Time And Date: 11 a.m.–6 p.m., May AGENCY: Centers for Disease Control and FOR FURTHER INFORMATION CONTACT: To
5–6, 2015 (Closed). Prevention (CDC), Department of Health request more information on the
Place: Teleconference. and Human Services (HHS). proposed project or to obtain a copy of
Status: The meeting will be closed to the information collection plan and
ACTION: Notice with comment period.
the public in accordance with instruments, contact the Information
provisions set forth in Section 552b(c) SUMMARY: The Centers for Disease Collection Review Office, Centers for
(4) and (6), Title 5 U.S.C., and the Control and Prevention (CDC), as part of Disease Control and Prevention, 1600
Determination of the Director, its continuing efforts to reduce public Clifton Road NE., MS–D74, Atlanta,
Management Analysis and Services burden and maximize the utility of Georgia 30329; phone: 404–639–7570;
Office, CDC, pursuant to Public Law 92– government information, invites the Email: omb@cdc.gov.
463. general public and other Federal SUPPLEMENTARY INFORMATION: Under the
Matters For Discussion: The meeting agencies to take this opportunity to Paperwork Reduction Act of 1995 (PRA)
will include the initial review, comment on proposed and/or (44 U.S.C. 3501–3520), Federal agencies
discussion, and evaluation of continuing information collections, as must obtain approval from the Office of
applications received in response to required by the Paperwork Reduction Management and Budget (OMB) for each
‘‘Natural Experiments of the Impact of Act of 1995. This notice invites collection of information they conduct
Population-targeted Health Policies to comment on the information collection or sponsor. In addition, the PRA also
Prevent Diabetes and its Complications, request for reinstatement with change of requires Federal agencies to provide a
asabaliauskas on DSK5VPTVN1PROD with NOTICES
DP15–001, initial review.’’ the collection previously approved 60-day notice in the Federal Register
Contact Person For More Information: under OMB control number 0920– concerning each proposed collection of
Brenda Colley Gilbert, Ph.D., M.S.P.H., 1005—‘‘Conduct an Older Adult information, including each new
Director, Extramural Research Program Mobility Assessment Tool Impact proposed collection, each proposed
Operations and Services, CDC, 4770 Evaluation and Develop a extension of existing collection of
Buford Highway NE., Mailstop F–80, Dissemination Plan’’. This collection information, and each reinstatement of
Atlanta, Georgia 30341, Telephone: will help evaluate whether the Mobility previously approved information
(770) 488–6295, BJC4@cdc.gov. Planning Tool is effective for promoting collection before submitting the
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![18850 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices
Leroy A. Richardson, contact person, site visit location(s), performance of its staff involved in
Chief, Information Collection Review Office, length of site visit, proposed dates, and regulatory review and in the premarket
Office of Scientific Integrity, Office of the maximum number of CDRH staff that review process. One of these initiatives,
Associate Director for Science, Office of the can be accommodated during a site the ELP Pilot, was launched in 2012 and
Director, Centers for Disease Control and visit. Proposals submitted without this fully implemented on April 2, 2013 (78
Prevention.
minimum information will not be FR 19711). CDRH is committed to
[FR Doc. 2015–08028 Filed 4–7–15; 8:45 am]
considered. In addition, please include advancing regulatory science; providing
BILLING CODE 4163–18–P an agenda outlining the proposed industry with predictable, consistent,
training for the site visit. A sample transparent, and efficient regulatory
request and agenda are available on the pathways; and helping to ensure
DEPARTMENT OF HEALTH AND
ELP Web site at http://www.fda.gov/ consumer confidence in medical
HUMAN SERVICES
downloads/ScienceResearch/ devices marketed in the United States
Food and Drug Administration ScienceCareerOpportunities/ and throughout the world. The ELP is
UCM392988.pdf and http:// intended to provide CDRH staff with an
[Docket No. FDA–2015–N–0986] www.fda.gov/scienceresearch/ opportunity to understand the policies,
sciencecareeropportunities/ laboratory practices, and challenges
Center for Devices and Radiological
ucm380676.htm. faced in broader disciplines that impact
Health: Experiential Learning Program
ADDRESSES: Submit either electronic the device development life cycle. This
AGENCY: Food and Drug Administration, requests to http://www.regulations.gov is a collaborative effort to enhance
HHS. or written requests to the Division of communication and facilitate the
ACTION: Notice. Dockets Management (HFA–305), Food premarket review process. Furthermore,
and Drug Administration, 5630 Fishers CDRH is committed to understanding
SUMMARY: The Food and Drug current industry practices, innovative
Administration (FDA), Center for Lane, Rm. 1061, Rockville, MD 20852.
Identify proposals with the docket technologies, regulatory impacts, and
Devices and Radiological Health (CDRH regulatory needs.
or Center) is announcing the 2015 number found in brackets in the
heading of this document. These formal training visits are not
Experiential Learning Program (ELP).
FOR FURTHER INFORMATION CONTACT: intended for FDA to inspect, assess,
This training component is intended to
Latonya Powell, Center for Devices and judge, or perform a regulatory function
provide CDRH staff with an opportunity
Radiological Health, Food and Drug (e.g., compliance inspection), but rather,
to understand the policies, laboratory
Administration, 10903 New Hampshire they are an opportunity to provide
practices, and challenges faced in
Ave., Bldg. 32, Rm. 5232, Silver Spring, CDRH review staff a better
broader disciplines that impact the
MD 20993–0002, 301–796–6965, FAX: understanding of the products they
device development life cycle. The
301–827–3079, Latonya.powell@ review. Through this notice, CDRH is
purpose of this document is to invite
fda.hhs.gov. formally requesting participation from
medical device industry, academia, and
companies, academia, and clinical
health care facilities to apply to SUPPLEMENTARY INFORMATION: facilities, including those that have
participate in this formal training
I. Background previously participated in the ELP or
program for FDA’s medical device
other FDA site visit programs.
review staff, or to contact CDRH for CDRH is responsible for ensuring the
more information regarding the ELP. safety and effectiveness of medical II. ELP
DATES: Submit either an electronic or devices marketed in the United States. A. ELP Training Component
written request for participation in the Furthermore, CDRH assures that
ELP by May 8, 2015. The proposal patients and providers have timely and In this training program, groups of
should include a description of your continued access to high-quality, safe, CDRH staff will observe operations at
facility relative to focus areas described and effective medical devices. In research, manufacturing, academia, and
in tables 1or 2). Please include the Area support of this mission, the Center health care facilities. The focus areas
of Interest (see tables 1or 2) that the site launched various training and and specific areas of interest for visits
visit will demonstrate to CDRH staff, a development initiatives to enhance may include the following:
TABLE 1—AREAS OF INTEREST—MEDICAL DEVICES/TECHNOLOGY
Focus area Specific areas of interest
Failure analysis of orthopedic de- Methods for retrieval and preservation of failed implants for analysis; understanding how retrieved implants
vices. may be analyzed; methods for identifying failure modes; understanding how analysis of failed implants
influences device design modifications.
Radiologic analysis of orthopedic Methods of radiologic analysis and associated data analyses; radiologic imaging core laboratories.
devices.
Automated external defibrillators Manufacturing process; incoming component inspection; design verification testing; human factors testing;
(AEDs). returned product testing (as available).
Diagnostic imaging catheters for Manufacturing process; design verification testing; returned product testing (as available); ultrasound, opti-
asabaliauskas on DSK5VPTVN1PROD with NOTICES
cardiovascular diseases. cal coherence tomography (OCT), and near infrared spectroscopy (NIS) catheters.
Endovascular grafts for treatment of Physician-sponsored clinical studies; observation of endovascular grafting surgical procedure; surgical
aortic aneurysms. planning process; factors that influence device modifications (e.g., patient anatomy, patient pathology).
Animal models for evaluation of he- Models of traumatic injury and severe hemorrhage; limitations of the model; understanding the relevance
mostatic devices. of the data generated from these models in evaluating hemostatic devices.
Hyaluronic acid in dermal tissue Manufacturing process; source materials; performance testing (e.g., material characterization, biocompat-
fillers. ibility, residence time).
Minimally invasive glaucoma sur- Observation of a MIGS procedure; surgical planning; surgical challenges.
gery (MIGS) devices.
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Document Created: 2018-02-21 10:07:02
Document Modified: 2018-02-21 10:07:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | Written comments must be received on or before June 8, 2015. | |
| Contact | 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: [email protected] | |
| FR Citation | 80 FR 18848 |
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