83 FR 4659 - Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Evidence-Based Falls Prevention Program; OMB Control Number, 0985-0039
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living Federal Register Volume 83, Issue 22 (February 1, 2018)
Administration for Community Living
Federal Register Volume 83, Issue 22 (February 1, 2018)
| Page Range | 4659-4660 | |
| FR Document | 2018-02000 |
[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)] [Notices] [Pages 4659-4660] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02000] [[Page 4659]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Evidence-Based Falls Prevention Program; OMB Control Number, 0985-0039 AGENCY: Administration for Community Living (ACL), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to ACL's Evidence-Based Falls Prevention Program's Proposed Extension with Changes of a Currently Approved Collection. DATES: Submit written comments on the collection of information by March 5, 2018. ADDRESSES: Submit written comments on the collection of information by: (a) Email to: [email protected], Attn: OMB Desk Officer for ACL; (b) fax to 202-395-5806, Attn: OMB Desk Officer for ACL; or (c) by mail to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW, Rm. 10235, Washington, DC 20503, Attn: OMB Desk Officer for ACL. FOR FURTHER INFORMATION CONTACT: Shannon Skowronski at [email protected] or 202-795-7438. 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. The Evidence-Based Falls Prevention Programs is a cooperative agreement financed through the Prevention and Public Health Fund (PPHF), most recently with FY 2017 PPHF funds. The statutory authority for cooperative agreements under the current program announcement is contained in the Public Health Service Act, 42 U.S.C. 300u-2 (Community Programs) and 300u-3 (Information Programs); and Consolidated Appropriations Act, 2017, Public Law 115-31, Title II; and the Patient Protection and Affordable Care Act, 42 U.S.C. 300u-11 (Prevention and Public Health Fund). The Evidence-Based Falls Prevention Programs support a national resource center and award competitive grants to implement evidence- based community programs that have been proven to reduce the incidence of falls for older adults. The programs also identify sustainable funding mechanisms for these programs via the national resource center, promote the importance of falls prevention strategies, and provide public education about the risks of falls and ways to prevent them. OMB approval of the existing set of Falls Prevention data collection tools (OMB Control Number, 0985-0039) expires on 01/31/2018. This data collection continues to be necessary for monitoring program operations and outcomes. ACL/AoA proposes to use the following tools: (1) Semi-annual performance reports to monitor grantee progress; (2) a Host Organization Data form to record the location of agencies that sponsor programs that will allow mapping of the delivery infrastructure; and (3) a set of tools used to collect information at each program completed by the program leaders (Program Information Cover Sheet and Attendance Log), a Participant Information Form completed by each participant, and a Post Program Survey to be completed by a random sample of participants. ACL/AoA intends to continue using an online data entry system for the program and participant survey data. Comments in Response to the 60-Day Federal Register Notice As required by 5 CFR 1320.8(d), a 60-Day notice was published in the Federal Register on October 3, 3017, Volume 82, Number 190, page 46064. Four emails were received with comments. Based on the comments, some minor modifications were made to the proposed survey instruments. In addition to the public comments, feedback on the current forms was sought from the following:ACL Performance and Evaluation subject matter experts CDC Injury Prevention Center subject matter experts National Falls Prevention Resource Center and falls prevention subject matter experts Two grantee focus groups (with fewer than 9 participants combined) Based on this collective feedback, the following modifications to the currently approved forms are being proposed: On the Participant Information Form: 1. Question #8 on currently approved and proposed Participant Information Form: Additional chronic conditions have been added to the list of options: Cancer; high blood pressure/hypertension; osteoporosis; and Parkinson's Disease. 2. Question #8 on currently approved and proposed Participant Information Form: None (no chronic conditions) has been removed from the list of options. 3. Question #11 on currently approved and proposed Participant Information Form: Two sub-questions have been added to assess the: Frequency of Falls (6b) Impact of Falls (6c) 4. Question #15 on the Participant Information Form has been added to examine home modifications 5. Question #16 on the Participant Information Form has been added to examine activity level On the Post Program Survey: 1. Question #2 on the currently approved and proposed Post Program Survey: Two sub-questions have been added to assess the: Frequency of Falls (6b) Impact of Falls (6c) 2. Question #4 on the currently approved Post Program Survey (``Has this program reduced your fear of falling?'') has been removed. 3. Question #7 on currently approved Post Program Survey and Question #6 on the proposed form: Removed ``I plan to continue exercising'' from the list of options. Activity level is now addressed in Question #9. 4. Question #8 on currently approved Post Program Survey and Question #7 on the proposed form: Removed ``Did exercises I learned in this program at home'' from the list of options. Activity level is now addressed in Question #9 on the revised form. 5. Question #8 on currently approved Post Program Survey and Question #7 on the proposed form: Removed ``Made changes in my home to reduce my risk of falling (for example, secured rugs or improved lighting)'' from the list of options. Home modifications are now addressed in Question #8 in the revised form. 6. Question #8 on the Participant Information Form has been added to examine home modifications 7. Question #9 on the Participant Information Form has been added to examine activity level On the Program Information Cover Sheet: 1. Question #6 has been revised to improve clarity to read ``Session 0/Introductory Session''. [[Page 4660]] 2. Question #7 has been revised to change wording to ``Name of program offered.'' Estimated Annualized Burden Hours The proposed Falls Prevention Data Collection Tools can be found at ACL's Website at: https://www.acl.gov/about-acl/public-input. The total estimated burden is 4,345 hours per year. ACL/AoA estimates the burden of this collection of information as 288 hours for project staff, 1,435 hours for local agency staff, and 2,622 hours for individuals. ---------------------------------------------------------------------------------------------------------------- Estimated Number of Average time Type of respondent Form name number of responses per per response Total burden respondents respondent (in hours) hours (annual) ---------------------------------------------------------------------------------------------------------------- Project staff................ Semi-annual 18............. Twice a year... 8 288 Performance Report. Local agency leaders......... Program 700 leaders.... Twice a year .50 700 Information (one set per Cover Sheet/ program). Participant Information Form/ Attendance Log/ Post Program Survey. Local data entry staff....... 36 data entry Once per .50 700 staff. program x 1,400 programs. Local organization staff and Host 700 staff...... 1.............. .05 35 local database entry staff. Organization Data Form. Program participants......... Participant 16,390......... 1.............. .10 1,639 Information Form. Program participants......... Post Program 9,834.......... 1.............. .10 983 Survey. ------------------------------- Total Burden Hours....... ............... ............... ............... .............. 4,345 ---------------------------------------------------------------------------------------------------------------- Dated: January 26, 2018. Mary Lazare, Principal Deputy Administrator. [FR Doc. 2018-02000 Filed 1-31-18; 8:45 am] BILLING CODE 4154-01-P
![4660 Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Notices
2. Question #7 has been revised to Estimated Annualized Burden Hours The total estimated burden is 4,345
change wording to ‘‘Name of program hours per year. ACL/AoA estimates the
offered.’’ The proposed Falls Prevention Data burden of this collection of information
Collection Tools can be found at ACL’s as 288 hours for project staff, 1,435
Website at: https://www.acl.gov/about- hours for local agency staff, and 2,622
acl/public-input. hours for individuals.
Average time Total burden
Estimated number of Number of responses
Type of respondent Form name per response hours
respondents per respondent (in hours) (annual)
Project staff ..................... Semi-annual Perform- 18 ................................... Twice a year ................... 8 288
ance Report.
Local agency leaders ...... Program Information 700 leaders .................... Twice a year (one set .50 700
Cover Sheet/Partici- per program).
pant Information Form/
Attendance Log/Post
Program Survey.
Local data entry staff ...... 36 data entry staff .......... Once per program × .50 700
1,400 programs.
Local organization staff Host Organization Data 700 staff ......................... 1 ..................................... .05 35
and local database Form.
entry staff.
Program participants ....... Participant Information 16,390 ............................ 1 ..................................... .10 1,639
Form.
Program participants ....... Post Program Survey ..... 9,834 .............................. 1 ..................................... .10 983
Total Burden Hours .. ......................................... ......................................... ......................................... .......................... 4,345
Dated: January 26, 2018. being conducted to satisfy one of FDA’s 796–2133, email: Yvonne.Knight@
Mary Lazare, performance goals included in the sixth fda.hhs.gov.
Principal Deputy Administrator. reauthorization of the Prescription Drug SUPPLEMENTARY INFORMATION:
[FR Doc. 2018–02000 Filed 1–31–18; 8:45 am] User Fee Act (PDUFA VI), part of the
BILLING CODE 4154–01–P FDA Reauthorization Act of 2017 I. Background
(FDARA), to hold a series of workshops Under FDARA, FDA agreed, in
related to model-informed drug accordance with section I of the PDUFA
DEPARTMENT OF HEALTH AND development (MIDD). VI Performance Goals, Ensuring the
HUMAN SERVICES DATES: The public workshop will be Effectiveness of the Human Drug
held on February 1, 2018, from 8 a.m. Review, part J, Enhancing Regulatory
Food and Drug Administration to 5 p.m., Eastern Time. See the Decision Tools to Support Drug
[Docket No. FDA–2018–N–0001] SUPPLEMENTARY INFORMATION section for Development and Review, to convene a
registration date and information. series of workshops to identify best
Best Practices in Modeling and ADDRESSES: The public workshop will practices for MIDD (https://
Simulation for Oncology Products; be held at the FDA White Oak Campus, www.fda.gov/downloads/ForIndustry/
Public Workshop 10903 New Hampshire Ave., Bldg. 31 UserFees/PrescriptionDrugUserFee/
Conference Center, the Great Room (Rm. UCM511438.pdf). FDA is conducting
AGENCY: Food and Drug Administration,
1503, B and C), Silver Spring, MD this workshop as part of the MIDD
HHS.
20993–0002. Entrance for public workshop series.
ACTION: Notice of public workshop. workshop participants (non-FDA Over the past few decades, there has
SUMMARY: The Food and Drug employees) is through Building 1 where been extensive investment in oncology
Administration’s (FDA, the Agency, or routine security procedures will be drug discovery and development.
we) Center for Drug Evaluation and performed. For parking and security Despite greater understanding of disease
Research (CDER), in co-sponsorship information, please refer to: http:// biology and drug mechanisms of action,
with the International Society of www.fda.gov/AboutFDA/ further progress in model-informed
Pharmacometrics (ISoP), is announcing WorkingatFDA/BuildingsandFacilities/ strategies is needed to continue
a public workshop entitled ‘‘Best WhiteOakCampusInformation/ advancements in oncology drug
Practices in Modeling and Simulation ucm241740.htm. development. Innovations in clinical
for Oncology Products.’’ The purpose of FOR FURTHER INFORMATION CONTACT: trial design utilizing more informative
the meeting is to discuss ‘‘best Jeannette Dinin, Center for Drug endpoints could help bring more
practices’’ in integrating Evaluation and Research, Food and effective treatment options to cancer
pharmacokinetic, pharmacodynamic, Drug Administration, 10903 New patients faster by accelerating
efficacy, and safety data into models to Hampshire Ave., Bldg. 22, Rm. 2108, development of effective new drugs and
sradovich on DSK3GMQ082PROD with NOTICES
best inform oncology drug development, Silver Spring, MD 20993–0002, 240– reducing failure rates in expensive late-
evaluate disease- and mechanism- 402–4978, email: Jeannette.Dinin@ phase development.
specific early endpoints to predict long- fda.hhs.gov; or Yvonne Knight, Center As more effective and complex
term efficacy, and discuss potential for Drug Evaluation and Research, Food combination strategies and novel targets
regulatory implications of model- and Drug Administration, 10903 New for cancer treatment evolve, exploring
informed decisions in drug Hampshire Ave., Bldg. 51, Rm. 2142, more informative and predictive
development. This workshop is also Silver Spring, MD 20993–0002, 301– endpoints to assess treatment response
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Document Created: 2018-10-26 13:46:00
Document Modified: 2018-10-26 13:46:00
| 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. | |
| Dates | Submit written comments on the collection of information by March 5, 2018. | |
| Contact | Shannon Skowronski at [email protected] or 202-795-7438. | |
| FR Citation | 83 FR 4659 |
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