Office of Women's Health General Update on Strategic Priorities and Initiatives, 63226-63227 [2015-26439]
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63226
Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
eligible to receive a waiver or deferral of
their repatriation loan. This form is to
be completed by eligible repatriates,
authorized legal custodian, or
authorized agency/individual.
Exemption applies to unaccompanied
minors and individuals eligible under
45 CFR 211, if no legal custodian is
identified.
7. The HHS Repatriation Program:
Temporary Assistance Extension
Request Form: under 45 CFR 211 & 212
temporary assistance may be furnished
beyond the 90 days eligibility period if
the repatriate meets the qualifications
established under Program regulations.
This form is to be completed by the
eligible repatriate, authorized legal
custodian, or the authorized agency/
individual. This form should be
submitted to ORR or its designated
grantee generally 14 days prior to the
expiration of the 90 days eligibility
period.
8. The HHS Repatriation Program:
State Request for Federal Support Form:
During emergency repatriation
activities, States activated by ORR are to
use this form to request support and/or
assistance from HHS, including but not
limited to required pre-approval of
expenditures, augmentation of State
personnel, funding, reimbursement,
among other things.
Respondents: Designated state,
federal, and/or non-governmental
agencies/individuals and eligible
repatriates. Responders are authorized
by 42 U.S.C. 1313 and 24 U.S.C. 321–
329; Executive Order 12656 (as
amended by E.O. 13074, February 9,
1998; E.O. 13228, October 8, 2001; E.O.
13286, February 28, 2003); and
regulations found under 45 CFR 211 &
212.
ANNUAL BURDEN ESTIMATES
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
Number of respondents
The HHS Repatriation Program: Emergency
and Group Processing Form.
The HHS Repatriation Program: Privacy and
Repayment Agreement Form.
The HHS Repatriation Program: Refusal of
Temporary Assistance Form.
The HHS Repatriation Program: Emergency
and Group Repatriation Financial Form.
The HHS Repatriation Program: Non-emergency Monthly Financial Statement Form.
The HHS Repatriation Program: Repatriation
Loan Waiver and Referral Request Form.
The HHS Repatriation Program: State Request for Federal Support.
The HHS Repatriation Program: Temporary
Assistance Extension Request Form.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Instrument
25,000 or more depending on the Emergency.
1,000 will increase during emergencies ........
1 ..................
0.30
7,500 or more.
1 ..................
0.05
50 or more.
15 or more ......................................................
1 ..................
0.05
0.75 or more.
15 or more ......................................................
1 ..................
0.30
4.5 or more.
52 or more ......................................................
12 ................
0.30
187 or more.
800 or more ....................................................
1 ..................
0.30
240 or more.
20 or more ......................................................
1 ..................
0.30
6 or more.
50 or more ......................................................
1 or more ....
0.30
15 or more.
Estimated Total Annual Burden
Hours: 8,003.
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:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
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: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
VerDate Sep<11>2014
17:52 Oct 16, 2015
Jkt 238001
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Office of Women’s Health General
Update on Strategic Priorities and
Initiatives
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
The Food and Drug
Administration (FDA) is announcing the
following meeting: Office of Women’s
Health General Update on Strategic
Priorities and Initiatives. FDA staff will
provide updates on strategic priorities,
educational outreach, and research
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
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The meeting will be held on
November 30, 2015, 9 a.m. to 11 a.m.
ADDRESSES: The meeting will be held at
the AARP Cy Brickfield Center, 601 East
St. NW., Washington, DC 20049.
FOR FURTHER INFORMATION CONTACT:
Deborah Kallgren, Office of Women’s
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–9440,
FAX: 301–847–8604, deborah.kallgren@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: There is
no fee, but pre-registration is required.
Send registration information (including
name, title, firm or organization name,
address, telephone, and fax number) to
Deborah Kallgren. Seating is limited to
25 participants (1 person per
organization).
If you need special accommodations
due to a disability, please contact
Deborah Kallgren (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
DATES:
[FR Doc. 2015–26467 Filed 10–16–15; 8:45 am]
AGENCY:
initiatives of interest to national
organizations focused on the health of
women.
E:\FR\FM\19OCN1.SGM
19OCN1
Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2015–26439 Filed 10–16–15; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2012–N–0471]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; User Fee Cover
Sheet; Form FDA 3397
AGENCY:
User Fee Cover Sheet; Form FDA 3397
(OMB Control Number 0910–0297)—
Extension
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
18, 2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0297. Also
SUMMARY:
Under the prescription drug user fee
provisions of the Federal Food, Drug,
and Cosmetic Act (sections 735 and 736
(21 U.S.C. 379g and 379h)), as amended,
FDA has the authority to assess and
collect user fees for certain drug and
biologics license applications (BLAs)
and supplements to those applications.
Under this authority, pharmaceutical
companies pay a fee for certain new
human drug applications (NDAs), BLAs,
or supplements submitted to the Agency
for review. Because the submission of
user fees concurrently with applications
and supplements is required, review of
an application by FDA cannot begin
until the fee is submitted. The
Prescription Drug User Fee Cover Sheet,
Form FDA 3397, is designed to provide
the minimum necessary information to
determine whether a fee is required for
review of an application, to determine
the amount of the fee required, and to
account for and track user fees. The
63227
form provides a cross-reference of the
fee submitted for an application by
using a unique number tracking system.
The information collected is used by
FDA’s Center for Drug Evaluation and
Research (CDER) and Center for
Biologics Evaluation and Research
(CBER) to initiate the administrative
screening of NDAs, BLAs, and/or,
supplemental applications to those
applications.
Respondents to this collection of
information are new drug and biologics
manufacturers. Based on FDA’s database
system for fiscal year (FY) 2014, there
are an estimated 290 manufacturers of
products subject to the Prescription
Drug User Fee Act (Pub. L. 105–115).
The total number of annual responses is
based on the number of submissions
received by FDA in FY 2014. CDER
received 3,005 annual responses that
include the following submissions: 128
NDAs; 7 BLAs; 1,586 manufacturing
supplements; 1,081 labeling
supplements; and 203 efficacy
supplements. CBER received 705 annual
responses that include the following
submissions: 11 BLAs; 611
manufacturing supplements; 64 labeling
supplements; and 19 efficacy
supplements. The estimated hours per
response are based on past FDA
experience with the various
submissions.
In the Federal Register of April 15,
2015 (80 FR 20232), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
FDA 3397 .............................................................................
290
12.79
3,710
0.5 (30 min.)
1,855
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26435 Filed 10–16–15; 8:45 am]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0776]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Reclassification Petitions for Medical
Devices
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:52 Oct 16, 2015
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PO 00000
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Reclassification Petitions for Medical
Devices’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\19OCN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Pages 63226-63227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26439]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Office of Women's Health General Update on Strategic Priorities
and Initiatives
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
following meeting: Office of Women's Health General Update on Strategic
Priorities and Initiatives. FDA staff will provide updates on strategic
priorities, educational outreach, and research initiatives of interest
to national organizations focused on the health of women.
DATES: The meeting will be held on November 30, 2015, 9 a.m. to 11 a.m.
ADDRESSES: The meeting will be held at the AARP Cy Brickfield Center,
601 East St. NW., Washington, DC 20049.
FOR FURTHER INFORMATION CONTACT: Deborah Kallgren, Office of Women's
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 301-796-9440, FAX: 301-847-8604,
deborah.kallgren@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: There is no fee, but pre-registration is
required. Send registration information (including name, title, firm or
organization name, address, telephone, and fax number) to Deborah
Kallgren. Seating is limited to 25 participants (1 person per
organization).
If you need special accommodations due to a disability, please
contact Deborah Kallgren (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance.
[[Page 63227]]
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26439 Filed 10-16-15; 8:45 am]
BILLING CODE 4164-01-P
