Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting, 26250-26251 [E9-12625]

Download as PDF 26250 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices Colesville Rd., Silver Spring, MD. The hotel telephone number is 301–589– 5200. Contact Person: Janie Kim, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301–827–7001, FAX: 301– 827–6776, email: Janie.kim@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572) in the Washington, DC area), code 3014512539. Please call the Information Line for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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 https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the appropriate advisory committee 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 July 21, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make 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 July 13, 2009. 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 VerDate Nov<24>2008 15:29 May 29, 2009 Jkt 217001 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 July 14, 2009. 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 Janie Kim 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 https://www.fda.gov/oc/advisory/ default.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: May 20, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–12627 Filed 5–29–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Dermatologic and Ophthalmic 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: Dermatologic and Ophthalmic 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 June 26, 2009, from 8 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, Maryland Ballrooms, 8727 Colesville Rd., Silver Spring, MD. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 The hotel phone number is 301–589– 5200. Contact Person: Paul Tran, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301–827–7001, FAX: 301– 827–6778, e-mail: paul.tran@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512534. Please call the Information Line for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss new drug applications (NDAs) 22–288, BEPREVE (bepotastine besilate) ophthalmic solution, 1.5%, ISTA Pharmaceuticals, Inc., proposed for the treatment of ocular itching associated with allergic conjunctivitis, and NDA 22–358, sodium hyaluronate ophthalmic solution, 0.18%, River Plate Biotechnology, Inc., proposed for the treatment of the signs and symptoms of dry eye disease. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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 https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the appropriate advisory committee 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 June 17, 2009. Oral presentations from the public will be scheduled between approximately 9:30 a.m. to 10 a.m., and 1:30 p.m. to 2 p.m. Those desiring to make 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 E:\FR\FM\01JNN1.SGM 01JNN1 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices participants, and an indication of the approximate time requested to make their presentation on or before June 11, 2009. 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 June 12, 2009. 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 John Lauttman at 301–827–7001, 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 https://www.fda.gov/oc/advisory/ default.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: May 20, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–12625 Filed 5–29–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Privacy Act of 1974, as Amended; Computer Matching Program AGENCY: Administration for Children and Families (ACF). ACTION: Notice of a computer matching program. SUMMARY: In compliance with the Privacy Act of 1974, as amended by Public Law 100–503, the Computer Matching and Privacy Protection Act of 1988, ACF is publishing a notice of a computer matching program. The purpose of this computer match is to identify specific individuals who are receiving benefits from the Department of Veterans Affairs (VA) and also VerDate Nov<24>2008 15:29 May 29, 2009 Jkt 217001 receiving payments pursuant to various benefit programs administered by both the Department of Health and Human Services (HHS) and the Department of Agriculture. ACF will facilitate this program on behalf of the State Public Assistance Agencies (SPAAs) that participate in the Public Assistance Reporting Information System (PARIS) for verification of continued eligibility for public assistance. The match will utilize VA and SPAA records. DATES: ACF will file a report of the subject matching program with the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Oversight and Government Reform of the House of Representatives and the Office of Information and Regulatory Affairs within the Office of Management and Budget (OMB). The dates for the matching program will be effective as indicated below. ADDRESSES: Interested parties may comment on this notice by writing to the Director, Office of Financial Services, Office of Administration, 370 L’Enfant Promenade, SW., Washington, DC 20047. All comments received will be available for public inspection at this address. FOR FURTHER INFORMATION CONTACT: Director, Office of Financial Services, Office of Administration, 370 L’Enfant Promenade, SW., Washington, DC 20047. Telephone: (202) 401–7237. SUPPLEMENTARY INFORMATION: Public Law 100–503, the Computer Matching and Privacy Protection Act of 1988, amended the Privacy Act (5 U.S.C. 552a) by adding certain protections for individuals applying for and receiving Federal benefits. The law regulates the use of computer matching by Federal agencies when records in a system of records are matched with other Federal, State, and local government records. Federal agencies that provide or receive records in computer matching programs must: 1. Negotiate written agreements with source agencies; 2. Provide notification to applicants and beneficiaries that their records are subject to matching; 3. Verify match findings before reducing, suspending, or terminating an individual’s benefits or payments; 4. Furnish detailed reports to Congress and OMB; and 5. Establish a Data Integrity Board that must approve matching agreements. This computer matching program meets the requirements of Public Law 100–503. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 26251 Dated: 05/27/2009. Curtis L. Coy, Deputy Assistant Secretary for Administration, ACF. Notice of Computer Matching Program A. PARTICIPATING AGENCIES VA and SPAAs. B. PURPOSE OF THE MATCH To identify specific individuals who are receiving benefits from the VA and also receiving payments pursuant to HHS and Department of Agriculture benefit programs, and to verify their continued eligibility for such benefits. SPAAs will contact affected individuals and seek to verify the information resulting from the match before initiating any adverse actions based on the match results. C. AUTHORITY FOR CONDUCTING THE MATCH The authority for conducting the matching program is contained in section 402(a)(6) of the Social Security Act [42 U.S.C. 602(a)(6)]. D. RECORDS TO BE MATCHED VA will disclose records from its Privacy Act system of records titled, ‘‘Compensation, Pension, Education, and Rehabilitation Records—VA (58VA21/22/28)’’ last published at 74 FR 14865 on April 1, 2009. VA’s disclosure of information for use in this computer match is listed as a routine use in this system of records. VA, as the source agency, will prepare electronic files containing the names and other personal identifying data of eligible veterans receiving benefits. These records are matched electronically against SPAA files consisting of data regarding monthly Medicaid, Temporary Assistance for Needy Families, general assistance, and Food Stamp beneficiaries. 1. The electronic files provided by the SPAAs will contain client names and Social Security Numbers (SSNs). 2. The resulting output returned to the SPAAs will contain personal identifiers, including names, SSNs, employers, current work or home addresses, etc. E. INCLUSIVE DATES OF THE MATCHING PROGRAM The effective date of the matching agreement and date when matching may actually begin shall be at the expiration of the 40-day review period for OMB and Congress, or 30 days after publication of the matching notice in the Federal Register, whichever date is later. The matching program will be in effect for 18 months from the effective date, with an option to renew for 12 additional months, unless one of the parties to the agreement advises the E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 74, Number 103 (Monday, June 1, 2009)]
[Notices]
[Pages 26250-26251]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12625]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


Dermatologic and Ophthalmic 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: Dermatologic and Ophthalmic 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 June 26, 2009, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, Maryland Ballrooms, 
8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301-
589-5200.
    Contact Person: Paul Tran, Center for Drug Evaluation and Research 
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301-827-
7001, FAX: 301-827-6778, e-mail: paul.tran@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512534. Please call the Information Line 
for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the 
meeting.
    Agenda: The committee will discuss new drug applications (NDAs) 22-
288, BEPREVE (bepotastine besilate) ophthalmic solution, 1.5%, ISTA 
Pharmaceuticals, Inc., proposed for the treatment of ocular itching 
associated with allergic conjunctivitis, and NDA 22-358, sodium 
hyaluronate ophthalmic solution, 0.18%, River Plate Biotechnology, 
Inc., proposed for the treatment of the signs and symptoms of dry eye 
disease.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. 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 https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2009 and scroll down to the appropriate advisory committee 
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 June 
17, 2009. Oral presentations from the public will be scheduled between 
approximately 9:30 a.m. to 10 a.m., and 1:30 p.m. to 2 p.m. Those 
desiring to make 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

[[Page 26251]]

participants, and an indication of the approximate time requested to 
make their presentation on or before June 11, 2009. 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 June 12, 2009.
    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 John Lauttman at 
301-827-7001, 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 https://www.fda.gov/oc/advisory/default.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: May 20, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-12625 Filed 5-29-09; 8:45 am]
BILLING CODE 4160-01-S

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