80 FR 63226 - Office of Women's Health General Update on Strategic Priorities and Initiatives
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 201 (October 19, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 201 (October 19, 2015)
| Page Range | 63226-63227 | |
| FR Document | 2015-26439 |
[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)] [Notices] [Pages 63226-63227] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. 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
![63226 Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
eligible to receive a waiver or deferral of established under Program regulations. limited to required pre-approval of
their repatriation loan. This form is to This form is to be completed by the expenditures, augmentation of State
be completed by eligible repatriates, eligible repatriate, authorized legal personnel, funding, reimbursement,
authorized legal custodian, or custodian, or the authorized agency/ among other things.
authorized agency/individual. individual. This form should be Respondents: Designated state,
Exemption applies to unaccompanied submitted to ORR or its designated federal, and/or non-governmental
minors and individuals eligible under grantee generally 14 days prior to the agencies/individuals and eligible
45 CFR 211, if no legal custodian is expiration of the 90 days eligibility repatriates. Responders are authorized
identified. period. by 42 U.S.C. 1313 and 24 U.S.C. 321–
7. The HHS Repatriation Program: 8. The HHS Repatriation Program: 329; Executive Order 12656 (as
Temporary Assistance Extension State Request for Federal Support Form: amended by E.O. 13074, February 9,
Request Form: under 45 CFR 211 & 212 During emergency repatriation 1998; E.O. 13228, October 8, 2001; E.O.
temporary assistance may be furnished activities, States activated by ORR are to 13286, February 28, 2003); and
beyond the 90 days eligibility period if use this form to request support and/or regulations found under 45 CFR 211 &
the repatriate meets the qualifications assistance from HHS, including but not 212.
ANNUAL BURDEN ESTIMATES
Number of Average
responses Total burden
Instrument Number of respondents burden hours
per hours
per response
respondent
The HHS Repatriation Program: Emergency 25,000 or more depending on the Emer- 1 .................. 0.30 7,500 or more.
and Group Processing Form. gency.
The HHS Repatriation Program: Privacy and 1,000 will increase during emergencies ........ 1 .................. 0.05 50 or more.
Repayment Agreement Form.
The HHS Repatriation Program: Refusal of 15 or more ...................................................... 1 .................. 0.05 0.75 or more.
Temporary Assistance Form.
The HHS Repatriation Program: Emergency 15 or more ...................................................... 1 .................. 0.30 4.5 or more.
and Group Repatriation Financial Form.
The HHS Repatriation Program: Non-emer- 52 or more ...................................................... 12 ................ 0.30 187 or more.
gency Monthly Financial Statement Form.
The HHS Repatriation Program: Repatriation 800 or more .................................................... 1 .................. 0.30 240 or more.
Loan Waiver and Referral Request Form.
The HHS Repatriation Program: State Re- 20 or more ...................................................... 1 .................. 0.30 6 or more.
quest for Federal Support.
The HHS Repatriation Program: Temporary 50 or more ...................................................... 1 or more .... 0.30 15 or more.
Assistance Extension Request Form.
Estimated Total Annual Burden Desk Officer for the Administration for initiatives of interest to national
Hours: 8,003. Children and Families. organizations focused on the health of
Additional Information: Copies of the women.
Robert Sargis,
proposed collection may be obtained by Reports Clearance Officer. DATES: The meeting will be held on
writing to the Administration for [FR Doc. 2015–26467 Filed 10–16–15; 8:45 am] November 30, 2015, 9 a.m. to 11 a.m.
Children and Families, Office of BILLING CODE 4184–01–P ADDRESSES: The meeting will be held at
Planning, Research and Evaluation, 370 the AARP Cy Brickfield Center, 601 East
L’Enfant Promenade SW., Washington, St. NW., Washington, DC 20049.
DC 20447, Attn: ACF Reports Clearance DEPARTMENT OF HEALTH AND
FOR FURTHER INFORMATION CONTACT:
Officer. All requests should be HUMAN SERVICES
Deborah Kallgren, Office of Women’s
identified by the title of the information
Food and Drug Administration Health, Food and Drug Administration,
collection. Email address: 10903 New Hampshire Ave., Silver
infocollection@acf.hhs.gov. Spring, MD 20993–0002, 301–796–9440,
[Docket No. FDA–2015–N–0001]
OMB Comment: OMB is required to FAX: 301–847–8604, deborah.kallgren@
make a decision concerning the Office of Women’s Health General fda.hhs.gov.
collection of information between 30 Update on Strategic Priorities and SUPPLEMENTARY INFORMATION: There is
and 60 days after publication of this Initiatives no fee, but pre-registration is required.
document in the Federal Register. AGENCY: Food and Drug Administration, Send registration information (including
Therefore, a comment is best assured of HHS. name, title, firm or organization name,
having its full effect if OMB receives it address, telephone, and fax number) to
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION: Notice of meeting.
within 30 days of publication. Written Deborah Kallgren. Seating is limited to
comments and recommendations for the SUMMARY: The Food and Drug 25 participants (1 person per
proposed information collection should Administration (FDA) is announcing the organization).
be sent directly to the following: Office following meeting: Office of Women’s If you need special accommodations
of Management and Budget, Paperwork Health General Update on Strategic due to a disability, please contact
Reduction Project, Email: OIRA_ Priorities and Initiatives. FDA staff will Deborah Kallgren (see FOR FURTHER
SUBMISSION@OMB.EOP.GOV, Attn: provide updates on strategic priorities, INFORMATION CONTACT) at least 7 days in
educational outreach, and research advance.
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![Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices 63227
Dated: October 13, 2015. include the FDA docket number found form provides a cross-reference of the
Leslie Kux, in brackets in the heading of this fee submitted for an application by
Associate Commissioner for Policy. document. using a unique number tracking system.
[FR Doc. 2015–26439 Filed 10–16–15; 8:45 am] The information collected is used by
FOR FURTHER INFORMATION CONTACT: FDA
FDA’s Center for Drug Evaluation and
BILLING CODE 4164–01–P PRA Staff, Office of Operations, Food
Research (CDER) and Center for
and Drug Administration, 8455
Biologics Evaluation and Research
Colesville Rd., COLE–14526, Silver
DEPARTMENT OF HEALTH AND (CBER) to initiate the administrative
Spring, MD 20993–0002, PRAStaff@
HUMAN SERVICES screening of NDAs, BLAs, and/or,
fda.hhs.gov.
supplemental applications to those
Food and Drug Administration SUPPLEMENTARY INFORMATION: In applications.
[Docket No. FDA–2012–N–0471] compliance with 44 U.S.C. 3507, FDA Respondents to this collection of
has submitted the following proposed information are new drug and biologics
Agency Information Collection collection of information to OMB for manufacturers. Based on FDA’s database
Activities; Submission for Office of review and clearance. system for fiscal year (FY) 2014, there
Management and Budget Review; are an estimated 290 manufacturers of
User Fee Cover Sheet; Form FDA 3397
Comment Request; User Fee Cover products subject to the Prescription
(OMB Control Number 0910–0297)—
Sheet; Form FDA 3397 Drug User Fee Act (Pub. L. 105–115).
Extension
The total number of annual responses is
AGENCY: Food and Drug Administration, Under the prescription drug user fee based on the number of submissions
HHS. provisions of the Federal Food, Drug, received by FDA in FY 2014. CDER
ACTION: Notice. and Cosmetic Act (sections 735 and 736 received 3,005 annual responses that
(21 U.S.C. 379g and 379h)), as amended, include the following submissions: 128
SUMMARY: The Food and Drug FDA has the authority to assess and NDAs; 7 BLAs; 1,586 manufacturing
Administration (FDA) is announcing collect user fees for certain drug and supplements; 1,081 labeling
that a proposed collection of biologics license applications (BLAs) supplements; and 203 efficacy
information has been submitted to the and supplements to those applications. supplements. CBER received 705 annual
Office of Management and Budget Under this authority, pharmaceutical responses that include the following
(OMB) for review and clearance under companies pay a fee for certain new submissions: 11 BLAs; 611
the Paperwork Reduction Act of 1995. human drug applications (NDAs), BLAs, manufacturing supplements; 64 labeling
DATES: Fax written comments on the or supplements submitted to the Agency supplements; and 19 efficacy
collection of information by November for review. Because the submission of supplements. The estimated hours per
18, 2015. user fees concurrently with applications response are based on past FDA
ADDRESSES: To ensure that comments on and supplements is required, review of experience with the various
the information collection are received, an application by FDA cannot begin submissions.
OMB recommends that written until the fee is submitted. The In the Federal Register of April 15,
comments be faxed to the Office of Prescription Drug User Fee Cover Sheet, 2015 (80 FR 20232), FDA published a
Information and Regulatory Affairs, Form FDA 3397, is designed to provide 60-day notice requesting public
OMB, Attn: FDA Desk Officer, FAX: the minimum necessary information to comment on the proposed collection of
202–395–7285, or emailed to oira_ determine whether a fee is required for information. No comments were
submission@omb.eop.gov. All review of an application, to determine received.
comments should be identified with the the amount of the fee required, and to FDA estimates the burden of this
OMB control number 0910–0297. Also account for and track user fees. The collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FDA Form responses per burden per Total hours
respondents responses
respondent response
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. DEPARTMENT OF HEALTH AND ACTION: Notice.
Leslie Kux, HUMAN SERVICES
Associate Commissioner for Policy. SUMMARY: The Food and Drug
[FR Doc. 2015–26435 Filed 10–16–15; 8:45 am]
Food and Drug Administration Administration (FDA) is announcing
BILLING CODE 4164–01–P
that a collection of information entitled
[Docket No. FDA–2011–N–0776] ‘‘Reclassification Petitions for Medical
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Devices’’ has been approved by the
Agency Information Collection Office of Management and Budget
Activities; Announcement of Office of (OMB) under the Paperwork Reduction
Management and Budget Approval; Act of 1995.
Reclassification Petitions for Medical
Devices FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
AGENCY: Food and Drug Administration, and Drug Administration, 8455
HHS. Colesville Rd., COLE–14526, Silver
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Document Created: 2015-12-15 08:35:28
Document Modified: 2015-12-15 08:35:28
| 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 of meeting. | |
| Dates | The meeting will be held on November 30, 2015, 9 a.m. to 11 a.m. | |
| 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, [email protected] | |
| FR Citation | 80 FR 63226 |
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