Guidance for Reviewers on Evaluating the Risks of Drug Exposure in Human Pregnancies; Availability, 22055-22056 [05-8466]

Download as PDF Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Notices 800–899–0381 or 301–827–0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1512) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. To receive a hard copy or electronic copy of ‘‘Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices,’’ you may either send a fax request to 301–443– 8818, or send an e-mail request to gwa@cdrh.fda.gov. Please use the document number (1512) to identify the guidance you are requesting. Persons interested in obtaining a copy of the guidance may also do so by using the Internet. CDRH maintains an entry on the Internet for easy access to information, including text, graphics, and files that may be downloaded to a personal computer with Internet access. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. 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 (the PRA) (44 U.S.C. 3501–3520). The collections of information addressed in the guidance document have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB control number 0910–0120). The labeling provisions addressed in the guidance have been approved by OMB under OMB control number 0910–0485. V. 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. VerDate jul<14>2003 16:00 Apr 27, 2005 Jkt 205001 Dated: April 4, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05–8468 Filed 4–27–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999D–1540] (formerly Docket No. 99D–1540) Guidance for Reviewers on Evaluating the Risks of Drug Exposure in Human Pregnancies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for reviewers entitled ‘‘Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies.’’ This guidance is intended to help FDA staff evaluate human fetal outcome data generated after medical product exposures during pregnancy. The goal of such evaluations is to assist in the development of product labeling that is useful to medical care providers when they care for patients who are pregnant or planning pregnancy. The review of human pregnancy drug exposure data and assessment of fetal risk (or lack of risk) requires consideration of human embryology and teratology, pharmacology, obstetrics, and epidemiology. Consequently, FDA staff also are encouraged to consult with experts in these fields, as appropriate. The guidance announced in this document finalizes the draft guidance entitled ‘‘Guidance for Reviewers: Evaluation of Human Pregnancy Outcome Data’’ announced in the Federal Register of June 4, 1999. DATES: Submit written comments 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, 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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 22055 either office in processing your requests. The guidance may also be obtained by mail by calling the CBER Voice Information System 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 the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Dianne L. Kennedy, Center for Drug Evaluation and Research (HFD–020), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–443–5162, e-mail: kennedyd@cder.fda.gov, or Toni M. Stifano, Center for Biologics Evaluation and Research (HFM–602), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 301– 827–6190, e-mail: stifano@cber.fda.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for reviewers entitled ‘‘Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies.’’ The guidance provides FDA staff with critical factors to consider when evaluating data on the effects of drug exposure during human pregnancies. It also describes the sources of human data on gestational drug exposures and available resources for more information. The guidance is intended to provide FDA reviewers with a standardized and scientific approach to the evaluation of the effects of human gestational drug exposures. In the Federal Register of June 4, 1999 (64 FR 30040), FDA announced the availability of a draft version of the guidance entitled ‘‘Guidance for Reviewers: Evaluation of Human Pregnancy Outcome Data.’’ When the draft guidance was published, FDA requested comments on the document. Three public comments were received. The comments were supportive of the agency’s efforts to provide this type of guidance. However, the comments also recommended revision/clarification of several sections, as well as provided a number of suggestions of a more technical nature. Additionally, comments regarding the draft guidance raised the following three broader concerns: (1) That it contained redundant information already presented in the guidance for industry entitled ‘‘Establishing Pregnancy Exposure Registries’’ (draft: 64 FR E:\FR\FM\28APN1.SGM 28APN1 22056 Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Notices 30040, June 4, 1999; final: 67 FR 59528, September 23, 2002), (2) that it focused too much on general epidemiologic issues, and (3) that it overemphasized the utility of pregnancy registries without a balanced review of the strengths of other data sources for evaluating pregnancy outcome data. Based on these comments and discussions with FDA’s Pregnancy Labeling Subcommittee of the Advisory Committee for Reproductive Health Drugs on June 3, 1999 (64 FR 23340, April 30, 1999), and March 28 and 29, 2000 (65 FR 10811, February 29, 2000), and with other interested parties, the draft guidance has been revised and finalized. The name has been changed from ‘‘Evaluating Pregnancy Outcome Data’’ to ‘‘Evaluating the Risks of Drug Exposure in Human Pregnancies’’ to reflect more accurately the information contained in the guidance. This guidance is being issued consistent with FDA’s good guidance practice regulation (21 CFR 10.115). The guidance represents the agency’s current thinking with regard to evaluating data on the effects of drug exposure during pregnancy. 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. Electronic Access Persons with access to the Internet may obtain the document at either http:/ /www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/cber/ guidelines.htm, or https://www.fda.gov/ ohrms/dockets/default.htm. Dated: April 19, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–8466 Filed 4–27–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: The National Health Service Corps (NHSC) Recruitment and Retention Assistance Application (OMB No. 0915–0230)—Revision The National Health Service Corps (NHSC) of the Bureau of Health Professions (BHPr), HRSA, is committed to improving the health of the Nation’s underserved by uniting communities in need with caring health professionals and by supporting communities’ efforts to build better systems of care. The Application for NHSC Recruitment and Retention Assistance submitted by sites or clinicians, requests information on the practice site, sponsoring agency, recruitment contact, staffing levels, service users, charges for services, employment policies, and fiscal management capabilities. Assistance in completing the application may be obtained through the appropriate State Primary Care Offices, State Primary Care Associations and NHSC Contractors. The information on the application is used for determining eligibility of sites and to verify the need for NHSC providers. Sites must apply once every three years. Estimates of annualized reporting burden are as follows: Type of report Number of respondents Response per respondents Hours per response Total burden hours Application ....................................................................................................... 2900 1 .5 1450 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: John Kraemer, Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: April 22, 2005. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. 05–8509 Filed 4–27–05; 8:45 am] In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: BILLING CODE 4165–15–P VerDate jul<14>2003 16:00 Apr 27, 2005 Jkt 205001 Health Resources and Services Administration Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting Name: Advisory Committee on Training in Primary Care Medicine and Dentistry. Date and Time: May 19, 2005, 8:30 a.m.– 4:30 p.m. and May 20, 2005, 8 a.m.–2 p.m. Place: The Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, Maryland 20814. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Status: The meeting will be open to the public. Purpose: The Advisory Committee provides advice and recommendations on a broad range of issues dealing with programs and activities authorized under section 747 of the Public Health Service Act as amended by The Health Professions Education Partnership Act of 1998, Public Law 105– 392. At this meeting the Advisory Committee will continue to work on its fifth report which will be submitted to Congress and to the Secretary of the Department of Health and Human Services in November 2005 and which focuses on measuring outcomes of Title VII, section 747 grant programs. Agenda: The meeting on Thursday, May 19, will begin with opening comments from the Chair of the Advisory Committee. A plenary session will follow in which Advisory Committee members will discuss various sections of the fifth report. The Advisory Committee will divide into E:\FR\FM\28APN1.SGM 28APN1

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[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Notices]
[Pages 22055-22056]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8466]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-1540] (formerly Docket No. 99D-1540)


Guidance for Reviewers on Evaluating the Risks of Drug Exposure 
in Human Pregnancies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for reviewers entitled ``Reviewer Guidance: 
Evaluating the Risks of Drug Exposure in Human Pregnancies.'' This 
guidance is intended to help FDA staff evaluate human fetal outcome 
data generated after medical product exposures during pregnancy. The 
goal of such evaluations is to assist in the development of product 
labeling that is useful to medical care providers when they care for 
patients who are pregnant or planning pregnancy. The review of human 
pregnancy drug exposure data and assessment of fetal risk (or lack of 
risk) requires consideration of human embryology and teratology, 
pharmacology, obstetrics, and epidemiology. Consequently, FDA staff 
also are encouraged to consult with experts in these fields, as 
appropriate.
    The guidance announced in this document finalizes the draft 
guidance entitled ``Guidance for Reviewers: Evaluation of Human 
Pregnancy Outcome Data'' announced in the Federal Register of June 4, 
1999.

DATES: Submit written comments 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, 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 either office in processing your requests. The guidance may also 
be obtained by mail by calling the CBER Voice Information System 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 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Dianne L. Kennedy, Center for Drug 
Evaluation and Research (HFD-020), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-5162, e-mail: 
kennedyd@cder.fda.gov, or Toni M. Stifano, Center for Biologics 
Evaluation and Research (HFM-602), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6190, e-mail: 
stifano@cber.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for reviewers 
entitled ``Reviewer Guidance: Evaluating the Risks of Drug Exposure in 
Human Pregnancies.'' The guidance provides FDA staff with critical 
factors to consider when evaluating data on the effects of drug 
exposure during human pregnancies. It also describes the sources of 
human data on gestational drug exposures and available resources for 
more information. The guidance is intended to provide FDA reviewers 
with a standardized and scientific approach to the evaluation of the 
effects of human gestational drug exposures.
    In the Federal Register of June 4, 1999 (64 FR 30040), FDA 
announced the availability of a draft version of the guidance entitled 
``Guidance for Reviewers: Evaluation of Human Pregnancy Outcome Data.'' 
When the draft guidance was published, FDA requested comments on the 
document. Three public comments were received. The comments were 
supportive of the agency's efforts to provide this type of guidance. 
However, the comments also recommended revision/clarification of 
several sections, as well as provided a number of suggestions of a more 
technical nature. Additionally, comments regarding the draft guidance 
raised the following three broader concerns: (1) That it contained 
redundant information already presented in the guidance for industry 
entitled ``Establishing Pregnancy Exposure Registries'' (draft: 64 FR

[[Page 22056]]

30040, June 4, 1999; final: 67 FR 59528, September 23, 2002), (2) that 
it focused too much on general epidemiologic issues, and (3) that it 
overemphasized the utility of pregnancy registries without a balanced 
review of the strengths of other data sources for evaluating pregnancy 
outcome data.
    Based on these comments and discussions with FDA's Pregnancy 
Labeling Subcommittee of the Advisory Committee for Reproductive Health 
Drugs on June 3, 1999 (64 FR 23340, April 30, 1999), and March 28 and 
29, 2000 (65 FR 10811, February 29, 2000), and with other interested 
parties, the draft guidance has been revised and finalized. The name 
has been changed from ``Evaluating Pregnancy Outcome Data'' to 
``Evaluating the Risks of Drug Exposure in Human Pregnancies'' to 
reflect more accurately the information contained in the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practice regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking with regard to evaluating data on the effects 
of drug exposure during pregnancy. 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. 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: April 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8466 Filed 4-27-05; 8:45 am]
BILLING CODE 4160-01-S

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