Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research” dated February 2001. This document, when finalized, is intended to provide guidance to sponsors of applications that are the subject of an open advisory committee meeting convened by the Center for Biologics Evaluation and Research (CBER), beginning on June 1, 2001. The draft guidance document provides procedures that will be adopted by CBER for making information provided to advisory committee members in connection with such meetings publicly available. The draft guidance document also describes how a sponsor should prepare its submission to an advisory committee.

DATES:

Submit written comments on the draft guidance to ensure their adequate consideration in preparation of the final document by May 21, 2001. General comments on agency guidance documents are welcome at any time. Submit written comments on the collection of information by May 21, 2001.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug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 the office in processing your requests. The document may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800, or by fax by calling the FAX Information System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit written comments on the document and on the collection of information to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Astrid L. Szeto, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft document entitled “Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research” dated February 2001. This draft guidance document, when finalized, is intended to provide guidance to sponsors of applications that are the subject of an open advisory committee meeting convened by CBER, beginning on June 1, 2001. The draft guidance document describes procedures that will be adopted by CBER for making information that is provided to advisory committee members in connection with such meetings publicly available. The draft guidance also describes how a sponsor should prepare its submission to an advisory committee.

In the Federal Register of November 30, 1999 (64 FR 66920), FDA issued a notice announcing the availability of a guidance document entitled “Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000” (the disclosure policy guidance). The disclosure policy guidance provided FDA’s interpretation of the Federal Advisory Committee Act (the FACA, 5 U.S.C. app. 2) and § 314.430 (21 CFR 314.430) with respect to the disclosure of materials provided to advisory committees, and how FDA will exercise its discretion under § 314.430(d)(1) in connection with open advisory committee meetings convened by the Center for Drug Evaluation and Research (CDER), beginning on January 1, 2000. In the Federal Register of December 22, 1999 (64 FR 71794), FDA announced the availability of a draft guidance document entitled “Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and Research, Beginning on January 1, 2000.” That draft guidance document was intended to provide the procedural information referenced in the disclosure policy guidance. Consistent with these principles and the regulations governing disclosure of information concerning biologic license applications at § 601.51 (21 CFR 601.51), CBER is providing this draft guidance on what sponsors may expect concerning the disclosure of information related to an open advisory committee meeting. As stated in the draft guidance, FDA interprets § 601.51 to be consistent with the FACA, and therefore, will exercise its discretion under § 601.51(d)(1) in a manner consistent with FACA and the Freedom of Information Act (the FOIA) (5 U.S.C. 552) to make available for public inspection and copying materials provided to members of an advisory committee in connection with open advisory committee meetings related to the testing or approval of biologic products and convened by CBER, beginning on June 1, 2001.

The draft guidance document entitled “Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research” being announced in this notice is intended to be consistent with CDER’s current guidance procedures where possible, and to describe procedures in making the process of complying with the disclosure requirements of the FACA as efficient as possible. These procedures address: (1) The content and organization of a sponsor submission for an advisory committee; (2) the timing of the sponsor submission to CBER; and (3) the process by which CBER will review and redact the sponsor submission and the related CBER submission. However, FDA may revise the draft CBER and CDER guidances based on comments received.

This draft guidance document is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). This draft guidance document represents the agency's current thinking on the implementation by CBER of the disclosure provisions of the FACA. 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. The Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Draft Guidance for Industry on Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research

FDA is issuing a draft guidance document on procedures that will be adopted by CBER for making information that is provided to advisory committee members in connection with open advisory committee meetings publicly available. The procedures address: (1) The content and organization of a sponsor submission for an advisory committee, (2) the timing of the sponsor submission to CBER, and (3) the process by which CBER will review and redact the sponsor submission and the related CBER submission. Under existing regulations in 21 CFR 14.35(a), sponsors routinely submit information to the agency that will be provided to advisory committee members in connection with advisory committee meetings. A sponsor may submit a package that the sponsor states should be fully disclosed to the public or a package that contains information the sponsor asserts should be withheld from public disclosure under the FOIA. This draft guidance describes the submission of information to the agency that will be provided to the members of an advisory committee in connection with an open advisory committee meeting related to the testing or approval of a biologic product and convened by CBER, beginning on June 1, 2001.

FDA construes the FACA to require that, with respect to any open advisory committee meeting convened under the FACA, whenever practicable and subject to any applicable exemption of the FOIA, those materials that are provided to the members of a CBER advisory committee in connection with that meeting must be made available for public inspection and copying before or at the time of the advisory committee meeting. Therefore, under the draft guidance document, a sponsor may submit two types of packages of materials for an advisory committee in connection with an open advisory committee meeting convened by CBER as follows: (1) A package that the sponsor states should be fully disclosed to the public because it does not contain information that should be withheld from public disclosure under an exemption under the FOIA; or (2) a package that contains information the sponsor asserts should be withheld from public disclosure under the FOIA and that, therefore, must be reviewed by the agency’s Freedom of Information staff to ensure that the appropriate information is redacted. The procedures for submitting the two collections of information are described in the draft guidance document.

A. Fully Releasable Submissions

In the draft guidance document, sponsors are strongly encouraged to submit advisory committee packages that may be publicly disclosed in their entirety (i.e., that do not contain any information that the sponsor wishes to assert is exempt from disclosure under the FOIA because it is trade secret or confidential commercial information, or because it is information the disclosure of which would constitute an unwarranted invasion of personal privacy, for example, by clearly identifying individual subjects). Sponsors are also encouraged to submit an electronic version of the package.

B. Submissions That Contain Material the Sponsor Asserts Are Exempt From Disclosure

A sponsor may believe that it is necessary to include material in an advisory committee package that it believes is exempt from disclosure. As described in the guidance, the agency recommends in this circumstance that the sponsor segregate the material it believes is exempt from disclosure from the disclosable material, clearly designate the material that the sponsor believes is exempt from disclosure, and provide a detailed justification of both why that specific information is necessary for the advisory committee’s consideration and why it is exempt from disclosure. Sponsors are also encouraged to submit an electronic version of the package.

1. Description of Respondents

A sponsor of an unapproved biological license application (BLA), BLA supplement, or a sponsor of an unapproved new drug application (NDA), NDA supplement, or abbreviated new drug application (ANDA) reviewed by CBER, or device (to the extent permitted by law and if the device application is being discussed in unison with a BLA) that is the subject of an open advisory committee convened by CBER, beginning on June 1, 2001.

2. Burden Estimate

Table 1 of this document provides an estimate of the annual reporting burden for the submission under the guidance of information to CBER that will be provided to the members of an advisory committee in connection with an open advisory committee meeting related to the testing or approval of a biologic product and convened by CBER, beginning on June 1, 2001.

In calendar year 2000, CBER received a total of eight submissions from six sponsors (respondents) in connection with open advisory committee meetings regarding the testing or approval of biologic products. CBER expects that annually, the number of submissions and respondents will remain approximately the same. The procedures for submitting this information that are set forth in the draft guidance document were not in place in calendar year 2000. However, based on CBER’s experience with the advisory committee process, and given that the guidance document strongly encourages respondents to submit advisory committee packages that may be publicly disclosed in their entirety, CBER estimates that approximately two-thirds of the total number of respondents (i.e., four respondents) will submit packages that may be disclosed in their entirety, and that approximately two-thirds of the total number of submissions that CBER receives (i.e., five responses) will be fully releasable. In addition, CBER estimates that approximately one-third of the total number of respondents (i.e., two respondents) will submit packages that contain material that the sponsor asserts is exempt from disclosure, and that approximately one-third of the submissions that CBER receives (i.e, three responses) will contain information that the sponsor asserts is exempt from disclosure.

Based on FDA experience and information provided to the agency by industry, FDA estimates that approximately 700 hours on average would be needed for the preparation of a fully releasable submission and 1,400 hours for that of a submission that contains information the respondent asserts is exempt from disclosure, including the time FDA expects it will take a sponsor to submit an electronic version of the package. The total estimated burden hours under the draft guidance are 7,700. FDA invites comments on the analysis of information collection burdens.

FDA estimates the burden of this information collection as follows:

III. Comments

This draft document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Dockets Management Branch (address above) written comments regarding this draft guidance document and on the collection of information. Submit written comments to ensure adequate consideration in preparation of the final document by May 21, 2001. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments should be identified with the docket number found in brackets in the heading of this document. A copy of the document and received comments are available for public examination in the Dockets Management Branch 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 http://www.fda.gov/cber/guidelines.htm.