80 FR 79046 - Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 80, Issue 243 (December 18, 2015)
Administration for Children and Families
Federal Register Volume 80, Issue 243 (December 18, 2015)
| Page Range | 79046-79047 | |
| FR Document | 2015-31774 |
[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)] [Notices] [Pages 79046-79047] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31774] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Disaster Information Collection Form. OMB No.: 0970--NEW. Description: This is a request by the Administration for Children and Families (ACF) for a generic clearance for the Disaster Information Collection Form. An approval for a generic clearance is being requested because each of the thirteen program offices within ACF has a slightly different need for information about program impact information collection during a disaster. ACF oversees more than 60 programs that affect the normal day to day operations of families, children, individuals and communities in the United States. Many of these programs encourage grantees or state administrators to develop emergency preparedness plans, but do not have statutory authority to require these plans be in place. ACF facilitates the inclusion of emergency preparedness planning and training efforts for ACF programs. Presidential Policy Directive-8 (PPD-8) provides federal guidance and planning procedures under established phases--protection, preparedness, response, recovery, and mitigation. The Disaster Information Collection Forms addressed in this clearance process provide assessment of ACF programs in disaster response, and recovery. ACF/Office of Human Services Emergency Preparedness and Response (OHSEPR) has a requirement under PPD-8, the National Response Framework, and the National Disaster Recovery Framework to report disaster impacts to ACF-supported human services programs to the HHS Secretary's Operation Center (SOC) and interagency partners. ACF/OHSEPR works in partnership with the Assistant Secretary for Preparedness and Response (ASPR), and the Federal Emergency Management Agency (FEMA) to report assessments of disaster impacted ACF programs and the status of continuity of services and recovery. Respondents: State administrators, and/or ACF grantees. Annual Burden Estimates: The burden cap for the Disaster Information Collection Form is estimated based on a single disaster per year. The estimate is for approximately 10 state administrators, or grantees to go through all of the applicable questions with the Regional and Central Office staff. Some ACF programs have more questions and may have more respondents. -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Instrument Number of responses per Burden hours per response Total burden hours respondents respondent -------------------------------------------------------------------------------------------------------------------------------------------------------- Disaster Information Collection Form 10 15 0.08 hours (5 minutes).................. 1.25 hours (75 minutes). -------------------------------------------------------------------------------------------------------------------------------------------------------- An estimate of the number of disasters that would warrant data collection is difficult to calculate due to the unpredictable nature of disasters. For example, in 2012, there were 95 disasters nationwide but OHSEPR did not collect data on all of them because they had minimal effects on ACF programs. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 [[Page 79047]] and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015-31774 Filed 12-17-15; 8:45 am] BILLING CODE 4184-01-P
![79046 Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices
approved collection; Title of a variety of formats. The specific ACF oversees more than 60 programs
Information Collection: Bid Pricing Tool education initiatives that utilize PBP that affect the normal day to day
(BPT) for Medicare Advantage (MA) and formulary data include web operations of families, children,
Plans and Prescription Drug Plans application tools on www.medicare.gov individuals and communities in the
(PDP); Use: We require that Medicare and the plan benefit insert in the United States. Many of these programs
Advantage organizations and Medicare & You handbook. In addition, encourage grantees or state
Prescription Drug Plans complete the organizations utilize the PBP data to administrators to develop emergency
BPT as part of the annual bidding generate their Summary of Benefits preparedness plans, but do not have
process. During this process, marketing information. The package has statutory authority to require these
organizations prepare their proposed been revised subsequent to the plans be in place. ACF facilitates the
actuarial bid pricing for the upcoming publication of the 60-day Federal inclusion of emergency preparedness
contract year and submit them to us for Register notice (September 24, 2015; 80 planning and training efforts for ACF
review and approval. The purpose of the FR 57619). Form Number: CMS–R–262 programs.
BPT is to collect the actuarial pricing (OMB control number 0938–0763);
information for each plan. The BPT Presidential Policy Directive–8 (PPD–
Frequency: Yearly; Affected Public: 8) provides federal guidance and
calculates the plan’s bid, enrollee Private sector (business or other for-
premiums, and payment rates. We planning procedures under established
profits and not-for-profit institutions);
publish beneficiary premium phases—protection, preparedness,
Number of Respondents: 552; Total
information using a variety of formats response, recovery, and mitigation. The
Annual Responses: 5,448; Total Annual
(www.medicare.gov, the Medicare & You Disaster Information Collection Forms
Hours: 52,902. (For policy questions
handbook, Summary of Benefits addressed in this clearance process
regarding this collection contact Kristy
marketing information) for the purpose provide assessment of ACF programs in
Holtje at 410–786–2209).
of beneficiary education and disaster response, and recovery.
Dated: December 15, 2015.
enrollment. The package has been ACF/Office of Human Services
revised subsequent to the publication of William N. Parham, III,
Emergency Preparedness and Response
the 60-day Federal Register notice Director, Paperwork Reduction Staff, Office (OHSEPR) has a requirement under
(September 24, 2015; 80 FR 57619). of Strategic Operations and Regulatory
PPD–8, the National Response
Affairs.
Form Number: CMS–10142 (OMB Framework, and the National Disaster
control number 0938–0944); Frequency: [FR Doc. 2015–31887 Filed 12–17–15; 8:45 am]
Recovery Framework to report disaster
Yearly; Affected Public: Private sector BILLING CODE 4120–01–P
impacts to ACF-supported human
(Business or other for-profits and Not- services programs to the HHS
for-profit institutions); Number of Secretary’s Operation Center (SOC) and
Respondents: 555; Total Annual DEPARTMENT OF HEALTH AND
interagency partners. ACF/OHSEPR
Responses: 4,995; Total Annual Hours: HUMAN SERVICES
works in partnership with the Assistant
149,850. (For policy questions regarding Secretary for Preparedness and
Administration for Children and
this collection contact Rachel Shevland Response (ASPR), and the Federal
Families
at 410–786–3026). Emergency Management Agency
3. Type of Information Collection Submission for OMB Review; (FEMA) to report assessments of disaster
Request: Revision of a currently Comment Request impacted ACF programs and the status
approved collection; Title of of continuity of services and recovery.
Information Collection: Contract Year Title: Disaster Information Collection
2017 Plan Benefit Package (PBP) Form. Respondents: State administrators,
Software and Formulary Submission; OMB No.: 0970—NEW. and/or ACF grantees.
Use: We require that Medicare Description: This is a request by the Annual Burden Estimates: The
Advantage and Prescription Drug Plan Administration for Children and burden cap for the Disaster Information
organizations submit a completed PBP Families (ACF) for a generic clearance Collection Form is estimated based on a
and formulary as part of the annual for the Disaster Information Collection single disaster per year. The estimate is
bidding process. During this process, Form. An approval for a generic for approximately 10 state
organizations prepare their proposed clearance is being requested because administrators, or grantees to go through
plan benefit packages for the upcoming each of the thirteen program offices all of the applicable questions with the
contract year and submit them to us for within ACF has a slightly different need Regional and Central Office staff. Some
review and approval. We publish for information about program impact ACF programs have more questions and
beneficiary education information using information collection during a disaster. may have more respondents.
Number of
Number of
Instrument responses per Burden hours per response Total burden hours
respondents respondent
Disaster Information Collection Form .................... 10 15 0.08 hours (5 minutes) ....... 1.25 hours (75 minutes).
An estimate of the number of disasters they had minimal effects on ACF DC 20447, Attn: ACF Reports Clearance
mstockstill on DSK4VPTVN1PROD with NOTICES
that would warrant data collection is programs. Officer. All requests should be
difficult to calculate due to the Additional Information: Copies of the identified by the title of the information
unpredictable nature of disasters. For proposed collection may be obtained by collection. Email address:
example, in 2012, there were 95 writing to the Administration for infocollection@acf.hhs.gov.
disasters nationwide but OHSEPR did Children and Families, Office of OMB Comment: OMB is required to
not collect data on all of them because Planning, Research and Evaluation, 370 make a decision concerning the
L’Enfant Promenade SW., Washington, collection of information between 30
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![Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices 79047
and 60 days after publication of this in the Washington, DC area). A notice in Persons attending FDA’s advisory
document in the Federal Register. the Federal Register about last minute committee meetings are advised that the
Therefore, a comment is best assured of modifications that impact a previously Agency is not responsible for providing
having its full effect if OMB receives it announced advisory committee meeting access to electrical outlets.
within 30 days of publication. Written cannot always be published quickly FDA welcomes the attendance of the
comments and recommendations for the enough to provide timely notice. public at its advisory committee
proposed information collection should Therefore, you should always check the meetings and will make every effort to
be sent directly to the following: Office Agency’s Web site at http://www.fda. accommodate persons with disabilities.
of Management and Budget, Paperwork gov/AdvisoryCommittees/default.htm If you require accommodations due to a
Reduction Project, Email: OIRA_ and scroll down to the appropriate disability, please contact Moon Hee V.
SUBMISSION@OMB.EOP.GOV, Attn: advisory committee meeting link, or call Choi at least 7 days in advance of the
Desk Officer for the Administration for the advisory committee information line meeting.
Children and Families. to learn about possible modifications FDA is committed to the orderly
before coming to the meeting. conduct of its advisory committee
Robert Sargis,
Agenda: The committee will discuss meetings. Please visit our Web site at
Reports Clearance Officer. http://www.fda.gov/Advisory
new drug application 206488, eteplirsen
[FR Doc. 2015–31774 Filed 12–17–15; 8:45 am] Committees/AboutAdvisoryCommittees/
injection for intravenous infusion,
BILLING CODE 4184–01–P sponsored by Sarepta Therapeutics, Inc., ucm111462.htm for procedures on
for the treatment of Duchenne muscular public conduct during advisory
dystrophy (DMD) in patients who have committee meetings.
DEPARTMENT OF HEALTH AND a confirmed mutation of the DMD gene Notice of this meeting is given under
HUMAN SERVICES that is amenable to exon 51 skipping. the Federal Advisory Committee Act (5
Food and Drug Administration FDA intends to make background U.S.C. app. 2).
material available to the public no later Dated: December 11, 2015.
[Docket No. FDA–2015–N–0001] than 2 business days before the meeting. Jill Hartzler Warner,
If FDA is unable to post the background Associate Commissioner for Special Medical
Peripheral and Central Nervous
material on its Web site prior to the Programs.
System Drugs Advisory Committee;
meeting, the background material will [FR Doc. 2015–31825 Filed 12–17–15; 8:45 am]
Notice of Meeting
be made publicly available at the
BILLING CODE 4164–01–P
AGENCY: Food and Drug Administration, location of the advisory committee
HHS. meeting, and the background material
ACTION: Notice. will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
the meeting. Background material is HUMAN SERVICES
This notice announces a forthcoming available at http://www.fda.gov/
meeting of a public advisory committee AdvisoryCommittees/Calendar/ Food and Drug Administration
of the Food and Drug Administration default.htm. Scroll down to the
[Docket No. FDA–2013–E–0474]
(FDA). The meeting will be open to the appropriate advisory committee meeting
public. link. Determination of Regulatory Review
Name of Committee: Peripheral and Procedure: Interested persons may Period for Purposes of Patent
Central Nervous System Drugs Advisory present data, information, or views, Extension; XTANDI
Committee. orally or in writing, on issues pending
General Function of the Committee: before the committee. Written AGENCY: Food and Drug Administration,
To provide advice and submissions may be made to the contact HHS.
recommendations to the Agency on person on or before January 7, 2016. ACTION: Notice.
FDA’s regulatory issues. Oral presentations from the public will
Date and Time: The meeting will be be scheduled between approximately SUMMARY: The Food and Drug
held on January 22, 2016, from 8 a.m. 12:40 p.m. and 2:40 p.m. Those Administration (FDA) has determined
to 5:30 p.m. individuals interested in making formal the regulatory review period for
Location: FDA White Oak Campus, oral presentations should notify the XTANDI and is publishing this notice of
10903 New Hampshire Ave., Bldg. 31 contact person and submit a brief that determination as required by law.
Conference Center, the Great Room (Rm. statement of the general nature of the FDA has made the determination
1503), Silver Spring, MD 20993–0002. evidence or arguments they wish to because of the submission of an
Answers to commonly asked questions present, the names and addresses of application to the Director of the U.S.
including information regarding special proposed participants, and an Patent and Trademark Office (USPTO),
accommodations due to a disability, indication of the approximate time Department of Commerce, for the
visitor parking, and transportation may requested to make their presentation on extension of a patent which claims that
be accessed at: http://www.fda.gov/ or before December 29, 2015. Time human drug product.
AdvisoryCommittees/AboutAdvisory allotted for each presentation may be DATES: Anyone with knowledge that any
Committees/ucm408555.htm. limited. If the number of registrants of the dates as published (in the
Contact Person: Moon Hee V. Choi, requesting to speak is greater than can SUPPLEMENTARY INFORMATION section) are
mstockstill on DSK4VPTVN1PROD with NOTICES
Center for Drug Evaluation and be reasonably accommodated during the incorrect may submit either electronic
Research, Food and Drug scheduled open public hearing session, or written comments and ask for a
Administration, 10903 New Hampshire FDA may conduct a lottery to determine redetermination by February 16, 2016.
Ave., Bldg. 31, rm. 2417, Silver Spring, the speakers for the scheduled open Furthermore, any interested person may
MD 20993–0002, 301–796–9001, FAX: public hearing session. The contact petition FDA for a determination
301–847–8533, PCNS@fda.hhs.gov, or person will notify interested persons regarding whether the applicant for
FDA Advisory Committee Information regarding their request to speak by extension acted with due diligence
Line, 1–800–741–8138 (301–443–0572 December 30, 2015. during the regulatory review period by
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Document Created: 2015-12-18 01:38:36
Document Modified: 2015-12-18 01:38:36
| 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 79046 |
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