Guidance for Industry on Reports on the Status of Postmarketing Study Commitments-Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997; Availability, 8307-8308 [E6-2184]

Download as PDF Federal Register / Vol. 71, No. 32 / Thursday, February 16, 2006 / Notices Dated: February 10, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6–2210 Filed 2–15–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science; Notice of Meeting AGENCY: Food and Drug Administration, HHS. dsatterwhite on PROD1PC65 with NOTICES 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: Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science. 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 April 18 and 19, 2006, from 8:30 a.m. to 5 p.m. Location: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. Contact Person: Mimi T. Phan, 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: PHANM@cder.fda.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. Agenda: On April 18, 2006, the subcommittee will: (1) Receive topic updates for ongoing activities pertaining to the International Conference on Harmonisation (ICH) Q8, Q9, Q10, and future ICH quality topics; and (2) discuss and provide comments on modernized Current Good Manufacturing Practice (CGMP) approaches to process validation that encourage continuous improvement over the product life-cycle. On April 19, 2006, the subcommittee will: (1) Discuss and provide comments on the agency’s VerDate Aug<31>2005 15:56 Feb 15, 2006 Jkt 208001 new approaches to Chemistry, Manufacturing, and Control (CMC) guidance development, as illustrated by the comparability protocol guidance; (2) discuss and provide comments on the CMC Pilot Program; and (3) receive an update on the Cooperative Research and Development Agreement (CRADA) with Conformia Software, Inc., to obtain information on factors influencing pharmaceutical development. The background material will become available no later than the day before the meeting and will be posted on FDA’s Web site at https://www.fda.gov/ ohrms/dockets/ac/acmenu.htm. (Click on the year 2006 and scroll down to the Advisory Committee for Pharmaceutical Science meetings.) Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittee. Written submissions may be made to the contact person by April 11, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 1:30 p.m. on April 18, 2006, and between approximately 11:30 a.m. and 12 noon on April 19, 2006. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before April 11, 2006, 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. 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 Mimi Phan 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 9, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–2237 Filed 2–15–06; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 8307 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999N–1852] (formerly 99N– 1852) Guidance for Industry on Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997; 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 ‘‘Reports on the Status of Postmarketing Study Commitments— Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997.’’ This guidance provides recommendations on procedures, content, and format for submitting a postmarketing study status report for an approved human drug or licensed biological product; timeframes for FDA’s review of postmarketing study commitments; and information about postmarketing study commitments that will be available to the public. The guidance is intended to assist applicants in meeting the requirements of section 130 of the Food and Drug Administration Modernization Act of 1997. Submit written or electronic comments on agency guidances at any time. DATES: Submit written requests for single copies of this guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your requests. The document may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. 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 ADDRESSES: E:\FR\FM\16FEN1.SGM 16FEN1 8308 Federal Register / Vol. 71, No. 32 / Thursday, February 16, 2006 / Notices the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller (CDER), Center for Drug Evaluation and Research (6411), Food and Drug Administration, 10903 New Hampshire Ave., bldg. 22, rm. 6466, Silver Spring, MD 20993, 301–796– 0700; or Robert Yetter (CBER), Center for Biologics Evaluation and Research (HFM–25), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301–827–0373. SUPPLEMENTARY INFORMATION: dsatterwhite on PROD1PC65 with NOTICES I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997.’’ Section 506B (‘‘Reports of Postmarketing Studies’’) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 356b) provides FDA with additional authority for monitoring the progress of postmarketing studies that drug and biological applicants have made a commitment to conduct. Postmarketing studies are those studies conducted after approval to gather additional information about the safety, efficacy, or optimal use of the approved drug or biological product. Under section 506B(a) of the act, an applicant who has entered into an agreement with FDA to conduct a postmarketing study is required to provide the agency with an annual report on the status of the study until FDA notifies the applicant, in writing, that all postmarketing study commitments established under the application(s) have either been fulfilled or have been released. The annual report must address the progress of the study or the reasons for the failure of the applicant to conduct the study. Section 506B(c) of the act directs FDA to develop and publish annually in the Federal Register a report on the status of postmarketing studies that applicants have made a commitment to conduct and for which status reports have been submitted. In the Federal Register of October 30, 2000 (65 FR 64607), the agency published a final rule to implement section 506B of the act. The final rule makes several changes to the existing regulations for approved human drugs and licensed biological products. In the Federal Register of April 4, 2001 (66 FR 17912), FDA published a VerDate Aug<31>2005 15:56 Feb 15, 2006 Jkt 208001 notice announcing the availability of a draft guidance for industry entitled ‘‘Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997.’’ The notice gave interested persons an opportunity to submit comments by July 3, 2001. A number of comments were received in the docket for the 2001 draft guidance. After careful consideration of the comments, the draft guidance was revised. In addition to edits to improve clarity, the substantive changes made to the draft guidance included an update of the types of postmarketing studies currently required by FDA and an improved explanation of the procedures for establishing and revising study schedules. This guidance is intended to provide information on the following: (1) Procedures concerning the submission of postmarketing study commitment status reports; (2) the content and format of a postmarketing study commitment status report; (3) timeframes for FDA’s review of postmarketing study commitment final study reports; and (4) information about postmarketing study commitments that will be available to the public. This guidance applies to postmarketing study commitments for approved human drug products and licensed biological products that meet the definition of ‘‘drug’’ under the act. It does not apply to biological products that meet the definition of medical ‘‘device’’ under the act; or to veterinary drug products, which will be addressed separately. 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 the submission of postmarketing study commitment reports for approved human drug or licensed biological 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. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 collections of information in 21 CFR 314.81 and 601.70 have been approved under OMB control numbers 0910–0001 and 0910–0433. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 III. 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 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. The guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm, https://www.fda.gov/cber/ guidelines.htm, or https://www.fda.gov/ ohrms/dockets/default.htm. Dated: February 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–2184 Filed 2–15–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5041–N–03] Notice of Proposed Information Collection: Comment Request; Builder’s Certification of Plans, Specifications, and Site Office of the Assistant Secretary for Housing-Federal Housing Commissioner, HUD. ACTION: Notice. AGENCY: SUMMARY: The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. DATES: Comments Due Date: April 17, 2006. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Lillian Deitzer, Reports Management Officer, Department of Housing and Urban Development, 451 7th Street, SW., L’Enfant Plaza Building, Room 8001, Washington, DC 20410 or Lillian_Deitzer@hud.gov. FOR FURTHER INFORMATION CONTACT: Margaret Burns, Director, Office of E:\FR\FM\16FEN1.SGM 16FEN1

Agencies

[Federal Register Volume 71, Number 32 (Thursday, February 16, 2006)]
[Notices]
[Pages 8307-8308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2184]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999N-1852] (formerly 99N-1852)


Guidance for Industry on Reports on the Status of Postmarketing 
Study Commitments--Implementation of Section 130 of the Food and Drug 
Administration Modernization Act of 1997; 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 ``Reports on the 
Status of Postmarketing Study Commitments--Implementation of Section 
130 of the Food and Drug Administration Modernization Act of 1997.'' 
This guidance provides recommendations on procedures, content, and 
format for submitting a postmarketing study status report for an 
approved human drug or licensed biological product; timeframes for 
FDA's review of postmarketing study commitments; and information about 
postmarketing study commitments that will be available to the public. 
The guidance is intended to assist applicants in meeting the 
requirements of section 130 of the Food and Drug Administration 
Modernization Act of 1997.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, or the Office of Communication, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your requests. The 
document may also be obtained by mail by calling CBER at 1-800-835-4709 
or 301-827-1800.
    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

[[Page 8308]]

the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT:
    Beth Duvall-Miller (CDER), Center for Drug Evaluation and Research 
(6411), Food and Drug Administration, 10903 New Hampshire Ave., bldg. 
22, rm. 6466, Silver Spring, MD 20993, 301-796-0700; or
    Robert Yetter (CBER), Center for Biologics Evaluation and Research 
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Reports on the Status of Postmarketing Study Commitments--
Implementation of Section 130 of the Food and Drug Administration 
Modernization Act of 1997.'' Section 506B (``Reports of Postmarketing 
Studies'') of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 356b) provides FDA with additional authority for monitoring the 
progress of postmarketing studies that drug and biological applicants 
have made a commitment to conduct. Postmarketing studies are those 
studies conducted after approval to gather additional information about 
the safety, efficacy, or optimal use of the approved drug or biological 
product.
    Under section 506B(a) of the act, an applicant who has entered into 
an agreement with FDA to conduct a postmarketing study is required to 
provide the agency with an annual report on the status of the study 
until FDA notifies the applicant, in writing, that all postmarketing 
study commitments established under the application(s) have either been 
fulfilled or have been released. The annual report must address the 
progress of the study or the reasons for the failure of the applicant 
to conduct the study. Section 506B(c) of the act directs FDA to develop 
and publish annually in the Federal Register a report on the status of 
postmarketing studies that applicants have made a commitment to conduct 
and for which status reports have been submitted. In the Federal 
Register of October 30, 2000 (65 FR 64607), the agency published a 
final rule to implement section 506B of the act. The final rule makes 
several changes to the existing regulations for approved human drugs 
and licensed biological products.
    In the Federal Register of April 4, 2001 (66 FR 17912), FDA 
published a notice announcing the availability of a draft guidance for 
industry entitled ``Reports on the Status of Postmarketing Studies--
Implementation of Section 130 of the Food and Drug Administration 
Modernization Act of 1997.'' The notice gave interested persons an 
opportunity to submit comments by July 3, 2001. A number of comments 
were received in the docket for the 2001 draft guidance. After careful 
consideration of the comments, the draft guidance was revised. In 
addition to edits to improve clarity, the substantive changes made to 
the draft guidance included an update of the types of postmarketing 
studies currently required by FDA and an improved explanation of the 
procedures for establishing and revising study schedules.
    This guidance is intended to provide information on the following: 
(1) Procedures concerning the submission of postmarketing study 
commitment status reports; (2) the content and format of a 
postmarketing study commitment status report; (3) timeframes for FDA's 
review of postmarketing study commitment final study reports; and (4) 
information about postmarketing study commitments that will be 
available to the public. This guidance applies to postmarketing study 
commitments for approved human drug products and licensed biological 
products that meet the definition of ``drug'' under the act. It does 
not apply to biological products that meet the definition of medical 
``device'' under the act; or to veterinary drug products, which will be 
addressed separately.
    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 the submission of postmarketing study 
commitment reports for approved human drug or licensed biological 
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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in 21 CFR 314.81 and 601.70 have been 
approved under OMB control numbers 0910-0001 and 0910-0433.

III. 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 
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. The guidance and received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

IV. Electronic Access

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

    Dated: February 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-2184 Filed 2-15-06; 8:45 am]
BILLING CODE 4160-01-S

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