Guidance for Industry on User Fee Waivers for Fixed Dose Combination and Co-Packaged Human Immunodeficiency Virus Drugs for the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Availability, 5976-5977 [E7-2124]

Download as PDF 5976 Federal Register / Vol. 72, No. 26 / Thursday, February 8, 2007 / Notices considered. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. A signed Confidential Disclosure Agreement will be required to receive a copy of any pending patent application. Dated: January 31, 2007. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E7–2077 Filed 2–7–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. jlentini on PROD1PC65 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices 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 March 1, 2007, from 8 a.m. to 5:30 p.m., and March 2, 2007, from 8 a.m. to 6 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: James Swink, Center for Devices and Radiological Health (HFZ–450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4179, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512625. Please call the Information Line for up-to-date information on this meeting. Agenda: On March 1, 2007, the committee will discuss and make recommendations regarding the premarket approval application, sponsored by Medtronic Inc., for the Chronicle Implantable Hemodynamic Monitoring System. This implantable device is intended to reduce hospitalization events or equivalent VerDate Aug<31>2005 15:58 Feb 07, 2007 Jkt 211001 events for worsening heart failure in patients with moderate to advanced heart failure. On March 2, 2007, the committee will discuss and make recommendations regarding clinical trial designs for Patent Foreman Ovale closure devices intended to prevent recurrent stroke. FDA intends to make background material available to the public no later than 1 business day 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 2007 and scroll down to the appropriate advisory committee link. Procedure: On March 1, 2007, from 8 a.m. to 5:30 p.m., and March 2, 2007, from 8 a.m. to 10 a.m. and 12 p.m. to 6 p.m., the meeting is open to the public. 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 February 23, 2007. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations on each day and for approximately 30 minutes near the end of the committee deliberations on each day. 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 February 15, 2007. 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 February 16, 2007. Closed Presentation of Data: On March 2, 2007, from 10 a.m. to 12 p.m., the meeting will be closed to permit the discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)) presented by sponsors. Persons attending FDA’s advisory committee meetings are advised that the PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 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 AnnMarie Williams, Conference Management Staff, at 301–827–7291, at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 1, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7–2122 Filed 2–7–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0091] Guidance for Industry on User Fee Waivers for Fixed Dose Combination and Co-Packaged Human Immunodeficiency Virus Drugs for the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.’’ This guidance describes the circumstances under which user fees will not be assessed for certain applications for fixed dose combination (FDC) and co-packaged versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV) under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief (PEPFAR). The guidance also describes some circumstances under which most of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver. DATES: Submit written or electronic comments on agency guidances at any time. Submit written requests for single copies of the guidance to the Division of Drug Information (HFD– ADDRESSES: E:\FR\FM\08FEN1.SGM 08FEN1 Federal Register / Vol. 72, No. 26 / Thursday, February 8, 2007 / Notices jlentini on PROD1PC65 with NOTICES 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to this guidance document. FOR FURTHER INFORMATION CONTACT: Michael Jones, Center for Drug Evaluation and Research (HFD–5), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 2041. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.’’ The guidance describes the circumstances under which user fees will not be assessed for certain applications for FDC and copackaged versions of previously approved antiretroviral therapies for the treatment of HIV under PEPFAR. The guidance also describes some circumstances under which some of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver. In May 2004, as part of PEPFAR, FDA issued a draft guidance entitled ‘‘Fixed Dose Combination and Co-Packaged Drug Products for the Treatment of HIV’’ (Fixed Dose Guidance) (69 FR 28931, May 19, 2004). The draft Fixed Dose Guidance described some scenarios for approval of FDC or co-packaged products for the treatment of HIV and provided examples of drug combinations considered acceptable for FDC/co-packaging and examples of those not considered acceptable for FDC/co-packaging. The guidance also explained that the Federal Food, Drug, and Cosmetic Act provides for certain circumstances in which FDA can grant sponsors a waiver or reduction in fees. The guidance also stated that the agency was evaluating the circumstances under which it may grant user fee waivers or reductions for sponsors developing FDC and co-packaged versions of previously approved antiretroviral therapies for the treatment of HIV. Since issuance of the draft Fixed Dose Guidance, several potential applicants have asked that we clarify whether sponsors submitting VerDate Aug<31>2005 15:58 Feb 07, 2007 Jkt 211001 drug applications covered by the draft Fixed Dose Guidance and proposed for use in the PEPFAR program will be required to pay user fees under the Prescription Drug User Fee Act (PDUFA) and, if so, whether they would be eligible for a waiver of those fees. In the Federal Register of April 18, 2005 (70 FR 20145), FDA announced the availability of a draft version of this guidance. FDA did not receive any comments in response to that draft guidance, and the agency has made only minor editorial changes to the guidance. This guidance describes some of the scenarios under which a sponsor could qualify for fee exemptions or would only be assessed a half fee, either because the sponsor is using an active ingredient that has already been approved or the application does not require clinical data for approval. A sponsor of an application that would be assessed either a full or a half fee may also qualify for a waiver of the application fee under several provisions of PDUFA. We expect that most of the applications, products, and establishments for FDC and co-packaged HIV therapies proposed for use in the PEPFAR program will either not be assessed fees in the first instance or will qualify for a waiver under the ‘‘other circumstances’’ part of the barrier-toinnovation user fee waiver. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on waivers for FDC and co-packaged HIV PEPFAR products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 5977 III. Electronic Access Persons with access to the Internet may obtain the guidance document at either https://www.fda.gov/cder/ guidance/index.htm or https:// www.fda.gov/ohrms/dockets/ default.htm. Dated: February 1, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2124 Filed 2–7–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Committee on Rural Health and Human Services; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given that the following committee will convene its fifty-fifth meeting. Name: National Advisory Committee on Rural Health and Human Services. Dates and Times: February 28, 2007, 9 a.m.–4:15 p.m., March 1, 2007, 9 a.m.–4:15 p.m., March 2, 2007, 9 a.m.–10:30 a.m. Place: The Sofitel Lafayette Square, 806 15th Street NW., Washington, DC 20005, Phone: 202–730–8800. Status: The meeting will be open to the public. Purpose: The National Advisory Committee on Rural Health and Human Services provides advice and recommendations to the Secretary with respect to the delivery, research, development and administration of health and human services in rural areas. Agenda: Wednesday morning, February 28, at 9 a.m., the meeting will be called to order by the Chairperson of the Committee, the Honorable David Beasley. Elizabeth M. Duke, Administrator of the Health Resources and Services Administration, has been invited to give opening remarks. The first presentation is titled Rural America: Then, Now and in the Future. The speakers will be John Cromartie and Carol Jones, Economic Research Service, U.S. Department of Agriculture. Following this session will be three panels on rural health and human services issues. The first will be a rural health panel with Becky Slifkin of the North Carolina Rural Health Research and Policy Analysis Center at the University of North Carolina at Chapel Hill; Gary Hart of the WWAMI Rural Health Research Center at the University of Washington; and Andy Coburn of the Maine Rural Health Research Center at the University of Southern Maine. The second will be a rural health panel with the following speakers: Julie Schoenman of the National Opinion Research Center at the University of Chicago; Michelle Casey of the E:\FR\FM\08FEN1.SGM 08FEN1

Agencies

[Federal Register Volume 72, Number 26 (Thursday, February 8, 2007)]
[Notices]
[Pages 5976-5977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2124]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0091]


Guidance for Industry on User Fee Waivers for Fixed Dose 
Combination and Co-Packaged Human Immunodeficiency Virus Drugs for the 
President's Emergency Plan for Acquired Immunodeficiency Syndrome 
Relief; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``User Fee Waivers for 
FDC and Co-Packaged HIV Drugs for PEPFAR.'' This guidance describes the 
circumstances under which user fees will not be assessed for certain 
applications for fixed dose combination (FDC) and co-packaged versions 
of previously approved antiretroviral therapies for the treatment of 
human immunodeficiency virus (HIV) under the President's Emergency Plan 
for Acquired Immunodeficiency Syndrome Relief (PEPFAR). The guidance 
also describes some circumstances under which most of the applications 
that will be assessed fees may be eligible for a public health or a 
barrier-to-innovation waiver.

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Division of Drug Information (HFD-

[[Page 5977]]

240), Center for Drug Evaluation and Research, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your 
requests. Submit written comments on the guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to this guidance document.

FOR FURTHER INFORMATION CONTACT: Michael Jones, Center for Drug 
Evaluation and Research (HFD-5), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for 
PEPFAR.'' The guidance describes the circumstances under which user 
fees will not be assessed for certain applications for FDC and co-
packaged versions of previously approved antiretroviral therapies for 
the treatment of HIV under PEPFAR. The guidance also describes some 
circumstances under which some of the applications that will be 
assessed fees may be eligible for a public health or a barrier-to-
innovation waiver.
    In May 2004, as part of PEPFAR, FDA issued a draft guidance 
entitled ``Fixed Dose Combination and Co-Packaged Drug Products for the 
Treatment of HIV'' (Fixed Dose Guidance) (69 FR 28931, May 19, 2004). 
The draft Fixed Dose Guidance described some scenarios for approval of 
FDC or co-packaged products for the treatment of HIV and provided 
examples of drug combinations considered acceptable for FDC/co-
packaging and examples of those not considered acceptable for FDC/co-
packaging. The guidance also explained that the Federal Food, Drug, and 
Cosmetic Act provides for certain circumstances in which FDA can grant 
sponsors a waiver or reduction in fees. The guidance also stated that 
the agency was evaluating the circumstances under which it may grant 
user fee waivers or reductions for sponsors developing FDC and co-
packaged versions of previously approved antiretroviral therapies for 
the treatment of HIV. Since issuance of the draft Fixed Dose Guidance, 
several potential applicants have asked that we clarify whether 
sponsors submitting drug applications covered by the draft Fixed Dose 
Guidance and proposed for use in the PEPFAR program will be required to 
pay user fees under the Prescription Drug User Fee Act (PDUFA) and, if 
so, whether they would be eligible for a waiver of those fees.
    In the Federal Register of April 18, 2005 (70 FR 20145), FDA 
announced the availability of a draft version of this guidance. FDA did 
not receive any comments in response to that draft guidance, and the 
agency has made only minor editorial changes to the guidance.
    This guidance describes some of the scenarios under which a sponsor 
could qualify for fee exemptions or would only be assessed a half fee, 
either because the sponsor is using an active ingredient that has 
already been approved or the application does not require clinical data 
for approval. A sponsor of an application that would be assessed either 
a full or a half fee may also qualify for a waiver of the application 
fee under several provisions of PDUFA.
    We expect that most of the applications, products, and 
establishments for FDC and co-packaged HIV therapies proposed for use 
in the PEPFAR program will either not be assessed fees in the first 
instance or will qualify for a waiver under the ``other circumstances'' 
part of the barrier-to-innovation user fee waiver.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on waivers for FDC and co-packaged HIV PEPFAR 
products. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. The draft guidance and received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at either https://www.fda.gov/cder/guidance/index.htm or http:/
/www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 1, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2124 Filed 2-7-07; 8:45 am]
BILLING CODE 4160-01-S

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