80 FR 47925 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 153 (August 10, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 153 (August 10, 2015)
| Page Range | 47925-47926 | |
| FR Document | 2015-19579 |
[Federal Register Volume 80, Number 153 (Monday, August 10, 2015)] [Notices] [Pages 47925-47926] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19579] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-15AME] 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 [email protected]. 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 Monitoring and Reporting System for the National Tobacco Control Program--New--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention (CDC) works with states, territories, tribal organizations, and the District of Columbia (collectively referred to as ``state-based'' programs) to develop, implement, manage, and evaluate tobacco prevention and control programs. Support and guidance for these programs have been provided through cooperative agreement funding and technical assistance administered by CDC's National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP). NCCDPHP cooperative agreements DP15-1509 (National State-Based Tobacco Control Programs) and DP14-1410PPHF14 (Public Health Approaches for Ensuring Quitline Capacity) continue to support efforts since 1999 to build state health department infrastructure and capacity to implement comprehensive tobacco prevention and control programs. Through these cooperative agreements, health departments in all 50 states, the District of Columbia, Puerto Rico and Guam are funded to implement evidence-based environmental, policy, and systems strategies and activities designed to reduce tobacco use, secondhand smoke exposure, tobacco-related disparities and associated disease, disability, and death. As part of routine monitoring, assessing progress, and ensuring accountability, cooperative agreement awardees will report information about their work plan objectives, activities, and performance measures. Each awardee will submit an Annual Work Plan Progress Report using an Excel- [[Page 47926]] based Work Plan Tool. The estimated burden per response is three hours for each Annual Work Plan Progress report. In addition, each awardee will submit an Annual Budget Progress Report using an Excel-based Budget Tool. The estimated burden per response is two hours for each Annual Budget Progress Report. In Year one, each awardee will have additional burden related to initial population of the reporting tools. Initial population of the Work Plan Tool is estimated to be six hours per response, and initial population of the Budget Tool is estimated to be four hours per response. Initial population of the tools is a one-time activity which is annualized over the three years of the information collection request. Due to annualization, the 53 awardees are represented as 18 awardees (53/3) in the burden table. After completing the initial population of the tools, pertinent information only needs to be updated for each annual report. The same instruments will be used for all information collection and reporting. Awardees will upload their information to www.grants.gov on an annual basis to satisfy routine cooperative agreement reporting requirements. CDC will use the information collected to monitor each awardee's progress and to identify facilitators and challenges to program implementation and achievement of outcomes. OMB approval is requested for three years. Participation in the information collection is required as a condition of funding. There are no costs to respondents other than their time. The total estimated annualized burden hours are 445. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response (in respondents respondent hours) ---------------------------------------------------------------------------------------------------------------- State Tobacco Control Managers... Initial Population 18 1 6 of the Work Plan Tool. Annual Work Plan 53 1 3 Progress Report. Initial Population 18 1 4 of the Budget Tool. Annual Budget 53 1 2 Progress Report. ---------------------------------------------------------------------------------------------------------------- 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. 2015-19579 Filed 8-7-15; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 80, No. 153 / Monday, August 10, 2015 / Notices 47925
and granted, EPA’s approval of the State DATES: The agency must receive other forms of information technology,
of Washington’s request to revise its part comments on or before October 9, 2015. e.g., permitting electronic submission of
142—National Primary Drinking Water ADDRESSES: Federal Communications responses; and (e) Assess information
Regulations Implementation program to Commission, 445 Twelfth Street SW., collection costs.
allow electronic reporting will become Washington, DC 20554. To request additional information on
effective 30 days after today’s notice is the proposed project or to obtain a copy
FOR FURTHER INFORMATION CONTACT:
published, pursuant to CROMERR of the information collection plan and
Tung Bui, 202–418–2700.
section 3.1000(f)(4). instruments, call (404) 639–7570 or
SUPPLEMENTARY INFORMATION: The full send an email to omb@cdc.gov. Written
Matthew Leopard, text of these applications is available for comments and/or suggestions regarding
Director, Office of Information Collection. inspection and copying during normal the items contained in this notice
[FR Doc. 2015–19577 Filed 8–7–15; 8:45 am] business hours in the Commission’s should be directed to the Attention:
BILLING CODE 6560–50–P Reference Center, 445 12th Street SW., CDC Desk Officer, Office of Management
Washington, DC 20554 or electronically and Budget, Washington, DC 20503 or
via the Media Bureau’s Consolidated by fax to (202) 395–5806. Written
FEDERAL COMMUNICATIONS Data Base System, http:// comments should be received within 30
COMMISSION licensing.fcc.gov/prod/cdbs/pubacc/ days of this notice.
prod/cdbs_pa.htm.
Radio Broadcasting Services; AM or Proposed Project
Federal Communications Commission.
FM Proposals To Change the James D. Bradshaw,
Monitoring and Reporting System for
Community of License the National Tobacco Control Program—
Deputy Chief, Audio Division, Media Bureau.
New—National Center for Chronic
AGENCY: Federal Communications [FR Doc. 2015–19575 Filed 8–7–15; 8:45 am]
Disease Prevention and Health
Commission. BILLING CODE 6712–01–P Promotion (NCCDPHP), Centers for
ACTION: Notice. Disease Control and Prevention (CDC).
SUMMARY: The following applicants filed DEPARTMENT OF HEALTH AND Background and Brief Description
AM or FM proposals to change the HUMAN SERVICES The Centers for Disease Control and
community of license: Blue Sky Prevention (CDC) works with states,
Broadcasting, Station KPND, Facility ID Centers for Disease Control and territories, tribal organizations, and the
5992, BPH–20150717AAV, From Prevention District of Columbia (collectively
Sandpoint, ID, To Dear Park, WA; referred to as ‘‘state-based’’ programs) to
Educational Media Foundation, Station [30Day–15–15AME]
develop, implement, manage, and
KARQ, Facility ID 90988, BPED– Agency Forms Undergoing Paperwork evaluate tobacco prevention and control
20150706ACR, From San Andreas, CA, Reduction Act Review programs. Support and guidance for
To Linden, CA; Educational Media these programs have been provided
Foundation, Station WDKL, Facility ID The Centers for Disease Control and through cooperative agreement funding
64662, BPH–20150601ACZ, From Prevention (CDC) has submitted the and technical assistance administered
Grafton, WV, To Loch Lynn Heights, following information collection request by CDC’s National Center for Chronic
MD; J&W Communications LLC, Station to the Office of Management and Budget Disease Prevention and Health
WAOQ, Facility ID 825, BPH– (OMB) for review and approval in Promotion (NCCDPHP).
20150515ABK, From Brantley, AL, To accordance with the Paperwork NCCDPHP cooperative agreements
Goshen, AL; Lakewood Reduction Act of 1995. The notice for DP15–1509 (National State-Based
Communications LLC, Station WKSR– the proposed information collection is Tobacco Control Programs) and DP14–
FM, Facility ID 27422, BPH– published to obtain comments from the 1410PPHF14 (Public Health Approaches
20150702AAL, From Lawrenceburg, TN, public and affected agencies. for Ensuring Quitline Capacity)
To Pulaski, TN; Lazer Licenses, LLC, Written comments and suggestions continue to support efforts since 1999 to
Station KCAL, Facility ID 55416, BP– from the public and affected agencies build state health department
20150603AAS, From Redlands, CA, To concerning the proposed collection of infrastructure and capacity to
Grand Terrace, CA; Mississippi College, information are encouraged. Your implement comprehensive tobacco
Station WHJT, Facility ID 43180, BPH– comments should address any of the prevention and control programs.
20150618AAS, From Clinton, MS, To following: (a) Evaluate whether the Through these cooperative agreements,
Kearney Park, MS; MTD, Inc., Station proposed collection of information is health departments in all 50 states, the
KNMB, Facility ID 87766, BPH– necessary for the proper performance of District of Columbia, Puerto Rico and
20150610AAR, From Cloudcroft, NM, the functions of the agency, including Guam are funded to implement
To Capitan, NM; Northwest Indy Radio, whether the information will have evidence-based environmental, policy,
Station KBSG, Facility ID 174954, practical utility; (b) Evaluate the and systems strategies and activities
BPED–20150610AAD, From Hoquiam, accuracy of the agencies estimate of the designed to reduce tobacco use,
WA, To Raymond, WA; Radio Dalhart, burden of the proposed collection of secondhand smoke exposure, tobacco-
Inc., Station KHJQ, Facility ID 82894, information, including the validity of related disparities and associated
BPH–20150625ACH, From Leakey, TX, the methodology and assumptions used; disease, disability, and death.
To Concan, TX; S and H Broadcasting, (c) Enhance the quality, utility, and As part of routine monitoring,
tkelley on DSK3SPTVN1PROD with NOTICES
LLC, Station KVGH, Facility ID 2316, clarity of the information to be assessing progress, and ensuring
BPH–20150622AFT, From North Shore, collected; (d) Minimize the burden of accountability, cooperative agreement
CA, To Bermuda Dunes, CA; Top O’ the collection of information on those awardees will report information about
Texas Ed B/Casting Foundation, Station who are to respond, including through their work plan objectives, activities,
KOGC, Facility ID 174505, BPED– the use of appropriate automated, and performance measures. Each
20150611ABM, From Wheeler, TX, To electronic, mechanical, or other awardee will submit an Annual Work
Carter, OK. technological collection techniques or Plan Progress Report using an Excel-
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![47926 Federal Register / Vol. 80, No. 153 / Monday, August 10, 2015 / Notices
based Work Plan Tool. The estimated Tool is estimated to be four hours per annual basis to satisfy routine
burden per response is three hours for response. Initial population of the tools cooperative agreement reporting
each Annual Work Plan Progress report. is a one-time activity which is requirements. CDC will use the
In addition, each awardee will submit annualized over the three years of the information collected to monitor each
an Annual Budget Progress Report using information collection request. Due to awardee’s progress and to identify
an Excel-based Budget Tool. The annualization, the 53 awardees are facilitators and challenges to program
estimated burden per response is two represented as 18 awardees (53/3) in the implementation and achievement of
hours for each Annual Budget Progress burden table. After completing the outcomes.
Report. initial population of the tools, pertinent OMB approval is requested for three
In Year one, each awardee will have information only needs to be updated years. Participation in the information
additional burden related to initial for each annual report. The same collection is required as a condition of
population of the reporting tools. Initial instruments will be used for all funding. There are no costs to
population of the Work Plan Tool is information collection and reporting. respondents other than their time. The
estimated to be six hours per response, Awardees will upload their total estimated annualized burden hours
and initial population of the Budget information to www.grants.gov on an are 445.
ESTIMATED ANNUALIZED BURDEN HOURS
Number Number of Average burden
Type of respondent Form name of responses per per response
respondents respondent (in hours)
State Tobacco Control Managers .......... Initial Population of the Work Plan Tool 18 1 6
Annual Work Plan Progress Report ...... 53 1 3
Initial Population of the Budget Tool ..... 18 1 4
Annual Budget Progress Report ........... 53 1 2
Leroy A. Richardson, Date and Time: The meeting will be Agenda: The committees will be
Chief, Information Collection Review Office, held on September 10, 2015, from 8 a.m. asked to discuss new drug application
Office of Scientific Integrity, Office of the to 5 p.m. (NDA) 206830, oxycodone immediate-
Associate Director for Science, Office of the release tablets, submitted by Purdue
Director, Centers for Disease Control and Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Pharma, with the proposed indication of
Prevention. the management of moderate to severe
[FR Doc. 2015–19579 Filed 8–7–15; 8:45 am] Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002. pain where the use of an opioid
BILLING CODE 4163–18–P
Answers to commonly asked questions analgesic is appropriate. It has been
formulated with the intent to provide
including information regarding special
abuse-deterrent properties. The
DEPARTMENT OF HEALTH AND accommodations due to a disability,
pharmacokinetic data demonstrate that
HUMAN SERVICES visitor parking, and transportation may
there is a significant food effect
be accessed at: http://www.fda.gov/
Food and Drug Administration resulting in a significant delay in
AdvisoryCommittees/
absorption and peak plasma
AboutAdvisoryCommittees/ concentration of oxycodone when taken
[Docket No. FDA–2015–N–0001] ucm408555.htm. with food. The applicant proposes to
Contact Person: Stephanie L. address this finding by labeling the
Joint Meeting of the Anesthetic and Begansky, Center for Drug Evaluation product to be taken on an empty
Analgesic Drug Products Advisory
and Research, Food and Drug stomach, but patients may have
Committee and the Drug Safety and
Administration, 10903 New Hampshire difficulty complying with these
Risk Management Advisory
Ave., Bldg. 31, Rm. 2417, Silver Spring, instructions as the product is dosed
Committee; Notice of Meeting
MD 20993–0002, 301–796–9001, FAX: every 4 to 6 hours as needed. The
AGENCY: Food and Drug Administration, 301–847–8533, email: AADPAC@ committees will be asked to discuss the
HHS. fda.hhs.gov, or FDA Advisory potential safety risks and the potential
Committee Information Line, 1–800– effects on efficacy associated with the
ACTION: Notice. 741–8138 (301–443–0572 in the delayed peak concentration when taken
Washington, DC area). A notice in the with food, and the feasibility of labeling
This notice announces a forthcoming Federal Register about last minute to be taken an empty stomach as a
meeting of two public advisory modifications that impact a previously means to mitigate the potential risks.
committees of the Food and Drug announced advisory committee meeting The committees will also be asked to
Administration (FDA). At least one cannot always be published quickly consider whether the potential public
portion of the meeting will be closed to enough to provide timely notice. health benefit of the product’s abuse-
the public. Therefore, you should always check the deterrent properties are sufficient to
Names of Committees: Anesthetic and Agency’s Web site at http:// outweigh the risk to patients who are
Analgesic Drug Products Advisory prescribed the product for the
tkelley on DSK3SPTVN1PROD with NOTICES
www.fda.gov/AdvisoryCommittees/
Committee and the Drug Safety and Risk default.htm and scroll down to the management of pain.
Management Advisory Committee. appropriate advisory committee meeting FDA intends to make background
General Function of the Committees: link, or call the advisory committee material available to the public no later
To provide advice and information line to learn about possible than 2 business days before the meeting.
recommendations to the Agency on modifications before coming to the If FDA is unable to post the background
FDA’s regulatory issues. meeting. material on its Web site prior to the
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Document Created: 2015-12-15 12:11:43
Document Modified: 2015-12-15 12:11:43
| 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 | |
| FR Citation | 80 FR 47925 |
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