Anti-Infective Drugs Advisory Committee; Notice of Meeting, 63407-63408 [2014-25218]

Download as PDF Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Notices receipt of your response, but will not receive individualized feedback on any suggestions. Postal Mail: ACF/Office of Child Support Enforcement, Attn: OCSE Report—Sheila Drake, 370 L’Enfant Promenade SW., 4th Floor East, Washington, DC 20447. Submissions by postal mail must be received by the deadline, and should allow sufficient time for security processing. SUPPLEMENTARY INFORMATION: This Request for Information offers the opportunity for interested individuals and organizations to provide input on specific Report requirements or other information that would be valuable to the Report development. mstockstill on DSK4VPTVN1PROD with NOTICES Background H.R. 4980 (Pub. L. 113–183), Preventing Sex Trafficking and Strengthening Families Act (Act) of 2014 was passed by both the House and Senate and then signed by the President on September 29, 2014. Under the Act’s Title III—Improving International Child Support Recovery, Section 305—Report to Congress, the Secretary, in conjunction with the strategic plan, is directed to review and provide recommendations for cost-effective improvements to the child support enforcement program funded under title IV–D of the Social Security Act and ensure that the plan addresses the effectiveness and performance of the program, analyzes program practices, identifies possible new collection tools and approaches, and identifies strategies for holding parents accountable for supporting their children and for building the capacity of parents to pay child support, with specific attention given to matters including front-end services, ongoing case management, collections, tribal-state partnerships, interstate and intergovernmental interactions, program performance, data analytics, and information technology. This shall be done in consultation with stakeholders including state, tribal, and county child support directors; judges who preside over family courts and organizations that represent the judges; custodial and noncustodial parents and the organizations that represent them; and fiduciaries such as financial institutions and employers. The Secretary shall submit a report to Congress not later than June 30, 2015, which will include: • An analysis of the effectiveness of state child support programs; • Recommendations for methods to enhance the effectiveness of child support programs and collection practices; VerDate Sep<11>2014 16:52 Oct 22, 2014 Jkt 235001 • A review of state best practices in regards to establishing and operating state and multistate lien registries; • A compilation of state recovery and distribution policies; • Options, with analysis, for methods to engage noncustodial parents in the lives of their children through consideration of parental time and visitation with children; • An analysis of the role of alternative dispute resolution in making child support determinations; • Identification of best practices for determining which services and support programs available to custodial and noncustodial parents are nonduplicative, evidence-based, produce quality outcomes, and connect parents to those services and support programs. Identification of best practices for providing employment support, job training, and job placement for custodial and noncustodial parents. Identification of best practices for establishing services and supports and child support tracking with options for preventing and resolving uncollectible arrears; • Options, with analysis, for methods for states to use to collect child support payments from individuals who owe excessive arrearages; • A review of state practices used to determine which individuals are excluded from the requirement to be reported to the Passport Denial program, including the extent to which individuals are able to successfully contest or appeal decisions; and • Options, with analysis, for such legislative and administrative actions as are determined to be appropriate for improvement in child support enforcement. Additional Instructions Regarding Comments To Be Submitted In your comments, please reference the specific paragraph of the legislation or issue area. Please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. Information obtained as a result of this notice may be used by the Federal Government for Report development. Please be aware that your comments may be posted online or cited in the Report. Authority: Sec. 305, Pub. L. 113–183, 128 Stat. 1919. Robert Sargis, Reports Clearance Officer. [FR Doc. 2014–25024 Filed 10–22–14; 8:45 am] BILLING CODE 4184–01–P PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 63407 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Anti-Infective Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Anti-Infective Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on December 4, 2014, from 8:30 a.m. to 5 p.m. Location: The Marriott Inn and Conference Center, University of Maryland University College (UMUC), The Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783. The conference center’s telephone number is 301–985–7300. Contact Person: Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, email: AIDAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options. FDA intends to make background material available to the public no later than 2 business days before the meeting. E:\FR\FM\23OCN1.SGM 23OCN1 mstockstill on DSK4VPTVN1PROD with NOTICES 63408 Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Notices If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 19, 2014. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 10, 2014. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 12, 2014. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Jennifer Shepherd at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). VerDate Sep<11>2014 16:52 Oct 22, 2014 Jkt 235001 Dated: October 17, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–25218 Filed 10–22–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than December 22, 2014. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Partnerships for Care (P4C). Supplemental Funding Progress Reports OMB No.: 0915–xxxx—New. Abstract: Partnerships for Care (P4C): Health Departments and Health Centers Collaborating to Improve HIV Health Outcomes is a 3-year cross-HHS project funded through the Secretary’s Minority AIDS Initiative (MAI) Fund and the Affordable Care Act (ACA). The goals of the P4C project are to build sustainable SUMMARY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 partnerships among CDC-funded state health departments (including Massachusetts, New York, Maryland, and Florida) and HRSA-funded health centers to support expanded HIV service delivery in communities highly impacted by HIV, especially among racial/ethnic minorities. State health departments and health centers will work together to increase the identification of undiagnosed HIV infection, establish new access points for HIV care and treatment, and improve HIV outcomes along the continuum of care for people living with HIV (PLWH) (see P4C fact sheet at http:// www.cdc.gov/hiv/prevention/ demonstration/p4c/index.html and HHS press release at http://www.hhs.gov/ news/press/2014pres/07/ 20140715a.html). Each eligible health center (22 across four funded states) will receive up to $500,000 annually in HRSA supplemental funding (totaling $33M across the 3-year project period) to integrate high-quality, comprehensive HIV services into their primary care programs; and to work in collaboration with their state health department to (1) identify people with undiagnosed HIV infection, (2) link newly diagnosed individuals to care, and (3) retain patients living with HIV in care. Health centers must implement activities in five focus areas including workforce development, infrastructure development, HIV service delivery, partnership development, and quality improvement and evaluation. Health centers must demonstrate progress toward implementing all required P4C activities and improving health care outcomes across the HIV care continuum (see http://aids.gov/federalresources/policies/care-continuum/). Need and Proposed Use of the Information: HRSA/Bureau of Primary Health Care (BPHC) proposes standardized data collection and reporting by the 22 health centers participating in the P4C project to achieve the following purposes: 1. Ensure appropriate stewardship of federal funds. 2. Support HHS efforts to streamline HIV data collection and reporting. 3. Assess health center progress in implementing approved work plans and meeting other P4C goals and objectives. 4. Assess health center progress in improving HIV outcomes across the HIV care continuum. 5. Support health center use of patient data to improve quality of HIV care. 6. Identify training and technical assistance needs among participating health centers. 7. Support identification and dissemination of effective models and E:\FR\FM\23OCN1.SGM 23OCN1

Agencies

[Federal Register Volume 79, Number 205 (Thursday, October 23, 2014)]
[Notices]
[Pages 63407-63408]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25218]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


Anti-Infective Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Anti-Infective Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 4, 2014, from 
8:30 a.m. to 5 p.m.
    Location: The Marriott Inn and Conference Center, University of 
Maryland University College (UMUC), The Ballroom, 3501 University Blvd. 
East, Hyattsville, MD 20783. The conference center's telephone number 
is 301-985-7300.
    Contact Person: Jennifer Shepherd, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, email: AIDAC@fda.hhs.gov, or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A 
notice in the Federal Register about last minute modifications that 
impact a previously announced advisory committee meeting cannot always 
be published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: The committee will discuss issues related to clinical 
development programs and clinical trial designs for antibacterial 
products for the treatment of patients with serious bacterial 
infections for which there are limited or no therapeutic options.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting.

[[Page 63408]]

If FDA is unable to post the background material on its Web site prior 
to the meeting, the background material will be made publicly available 
at the location of the advisory committee meeting, and the background 
material will be posted on FDA's Web site after the meeting. Background 
material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee 
meeting link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
November 19, 2014. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those individuals interested in 
making formal oral presentations should notify the contact person and 
submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation on or before November 10, 2014. Time allotted 
for each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak by November 12, 2014.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Jennifer Shepherd at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25218 Filed 10-22-14; 8:45 am]
BILLING CODE 4164-01-P