Draft Guidance for Industry on Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications; Availability, 50801-50802 [E9-23616]

Download as PDF Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices Dated: September 20, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–23681 Filed 9–30–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2009–E–0017 and FDA– 2009–E–0019] Determination of Regulatory Review Period for Purposes of Patent Extension; CLEVIPREX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. PWALKER on DSK8KYBLC1PROD with NOTICES SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for CLEVIPREX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions 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.regulations.gov. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug VerDate Nov<24>2008 19:32 Sep 30, 2009 Jkt 217001 products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product CLEVIPREX (clevidipine butyrate). CLEVIPREX is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for CLEVIPREX (U.S. Patent Nos. 5,739,152 and 5,856,346) from AstraZeneca AB, and the Patent and Trademark Office requested FDA’s assistance in determining the patents’ eligibilities for patent term restoration. In a letter dated February 18, 2009, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of CLEVIPREX represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for CLEVIPREX is 4,475 days. Of this time, 4,078 days occurred during the testing phase of the regulatory review period, while 397 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and CosmeticAct (the act) (21 U.S.C. 355(i)) became effective: May 3, 1996. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on May 3, 1996. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: July 2, 2007. FDA has verified the applicant’s claim that the PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 50801 new drug application (NDA) 22–156 was submitted on July 2, 2007. 3. The date the application was approved: August 1, 2008. FDA has verified the applicant’s claim that NDA 22–156 was approved on August 1, 2008. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,314 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by November 30, 2009. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 30, 2010. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, 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. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 23, 2009. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E9–23650 Filed 9–30–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0461] Draft Guidance for Industry on Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications; Availability AGENCY: Food and Drug Administration, HHS. E:\FR\FM\01OCN1.SGM 01OCN1 50802 PWALKER on DSK8KYBLC1PROD with NOTICES ACTION: Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.’’ The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the act) giving FDA the authority to require REMS. The draft guidance describes the format and content of a proposed risk evaluation and mitigation strategy, including REMS supporting documentation, the content of assessments and proposed modifications of approved REMS, what identifiers to use on REMS documents, and how to communicate with FDA about a REMS. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by December 30, 2009. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002; or the Office of Communication, Outreach, and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. The draft guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827– 1800. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft 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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding questions for the Center for Drug Evaluation and Research: Kathleen Frost, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4316, Silver Spring, MD 20993–0002, 301–796–2380. VerDate Nov<24>2008 19:32 Sep 30, 2009 Jkt 217001 Regarding questions for the Center for Biologics Evaluation and Research: Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301– 827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.’’ On September 27, 2007, the President signed into law FDAAA (Public Law 110–85). Title IX, Subtitle A, section 901 of FDAAA created new section 505– 1 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355– 1). Section 505–1(a) of the act authorizes FDA to require persons who submit certain applications or hold certain approved applications1 to submit a proposed REMS if FDA determines that a REMS is necessary to ensure that the benefits of a drug outweigh the risks of the drug and informs the holder of the application for the drug of the determination. Sections 505–1(c) through (f) describe the content of a required strategy. Section 505–1(g) describes assessments and modifications of an approved strategy. The draft guidance provides information regarding FDA’s current thinking on the format and content that should be used for submissions of proposed REMS, including a description of REMS supporting documentation. It also includes preliminary information on the content of assessments and proposed modifications of approved REMS, information on identifiers that should be included on the first page of REMS submissions, and information on whom to contact to communicate with FDA about a REMS. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on the format and content of proposed REMS, REMS assessments, and proposed REMS modifications. 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 1 Section 505–1(b)(2) of the act (21 U.S.C. 355(p)(1)) provides that section 505–1 of the act applies to applications for prescription drugs approved under section 505(b) or (j) of the act and applications approved under section 351 of the Public Health Service Act (42 U.S.C. 262). See Section 505(p)(1). PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 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 paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collection of information in the guidance was approved under OMB control numbers 0910–0001 and 0910– 0338. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm or https:// www.regulations.gov. Dated: September 25, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–23616 Filed 9–30–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Children’s Study Advisory Committee. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: National Children’s Study Advisory Committee. E:\FR\FM\01OCN1.SGM 01OCN1

Agencies

[Federal Register Volume 74, Number 189 (Thursday, October 1, 2009)]
[Notices]
[Pages 50801-50802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0461]


Draft Guidance for Industry on Format and Content of Proposed 
Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and 
Proposed REMS Modifications; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 50802]]


ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Format and 
Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), 
REMS Assessments, and Proposed REMS Modifications.'' The Food and Drug 
Administration Amendments Act of 2007 (FDAAA) added new provisions to 
the Federal Food, Drug, and Cosmetic Act (the act) giving FDA the 
authority to require REMS. The draft guidance describes the format and 
content of a proposed risk evaluation and mitigation strategy, 
including REMS supporting documentation, the content of assessments and 
proposed modifications of approved REMS, what identifiers to use on 
REMS documents, and how to communicate with FDA about a REMS.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by December 30, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or 
the Office of Communication, Outreach, and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The 
draft guidance may also be obtained by mail by calling CBER at 1-800-
835-4709 or 301-827-1800. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft 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.regulations.gov. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding questions for the Center for Drug Evaluation and 
Research: Kathleen Frost, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4316, 
Silver Spring, MD 20993-0002, 301-796-2380.
    Regarding questions for the Center for Biologics Evaluation and 
Research: Stephen Ripley, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Format and Content of Proposed Risk Evaluation and 
Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS 
Modifications.'' On September 27, 2007, the President signed into law 
FDAAA (Public Law 110-85). Title IX, Subtitle A, section 901 of FDAAA 
created new section 505-1 of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 355-1). Section 505-1(a) of the act authorizes FDA 
to require persons who submit certain applications or hold certain 
approved applications\1\ to submit a proposed REMS if FDA determines 
that a REMS is necessary to ensure that the benefits of a drug outweigh 
the risks of the drug and informs the holder of the application for the 
drug of the determination. Sections 505-1(c) through (f) describe the 
content of a required strategy. Section 505-1(g) describes assessments 
and modifications of an approved strategy.
---------------------------------------------------------------------------

    \1\ Section 505-1(b)(2) of the act (21 U.S.C. 355(p)(1)) 
provides that section 505-1 of the act applies to applications for 
prescription drugs approved under section 505(b) or (j) of the act 
and applications approved under section 351 of the Public Health 
Service Act (42 U.S.C. 262). See Section 505(p)(1).
---------------------------------------------------------------------------

    The draft guidance provides information regarding FDA's current 
thinking on the format and content that should be used for submissions 
of proposed REMS, including a description of REMS supporting 
documentation. It also includes preliminary information on the content 
of assessments and proposed modifications of approved REMS, information 
on identifiers that should be included on the first page of REMS 
submissions, and information on whom to contact to communicate with FDA 
about a REMS.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the format 
and content of proposed REMS, REMS assessments, and proposed REMS 
modifications. 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 paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in the guidance was approved under OMB 
control numbers 0910-0001 and 0910-0338.

IV. Electronic Access

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

    Dated: September 25, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23616 Filed 9-30-09; 8:45 am]
BILLING CODE 4160-01-S

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