[Federal Register Volume 66, Number 55 (Wednesday, March 21, 2001)]
[Notices]
[Pages 15877-15880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6937]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0086]


Draft Guidance for Industry: Disclosing Information Provided to 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.

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[[Page 15878]]

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 The draft guidance document provides procedures that will 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The draft guidance document also describes how a sponsor should prepare 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DATES: Submit written comments on the draft guidance to ensure their 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 Sec. 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 Sec. 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 Sec. 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 Sec. 601.51 to 
be consistent with the FACA, and therefore, will exercise its 
discretion under Sec. 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

[[Page 15879]]

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,

[[Page 15880]]

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:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                                      No. of
           Submissions                No. of       responses per   Total annual      Hours per      Total hours
                                    respondents     respondent       responses       response
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Fully releasable submissions            4               1.25            5             700           3,500
Submissions that contain                2               1.5             3           1,400           4,200
 material that is claimed to be
 exempt from disclosure
                                 -------------------------------------------------------------------------------
Total                                   6         ..............        8         ..............    7,700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

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.

    Dated: March 9, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-6937 Filed 3-20-01; 8:45 am]
BILLING CODE 4160-01-S