Guidance for Industry
`
`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
`
`DRAFT GUIDANCE
`
`This guidance document is being distributed for
`comment purposes only.
`
`Comments and suggestions regarding this draft document should be submitted within 60 days of
`publication in the Federal Register of the notice announcing the availability of the draft guidance.
`Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
`Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket
`number listed in the notice of availability that publishes in the Federal Register.
`
`For questions on the content of the draft document contact Murray M. Lumpkin at 301-594-5400.
`
`U.S. Department of Health and Human Services
`Food and Drug Administration
`Center for Drug Evaluation and Research (CDER)
`
`December 1999
`Procedural
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`Guidance for Industry
`
`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
`
`Additional copies are available from:
`Drug Information Branch (HFD-210),
`Center for Drug Evaluation and Research (CDER),
`5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573
`http://www.fda.gov/cder/guidance/index.htm
`
`U.S. Department of Health and Human Services
`Food and Drug Administration
`Center for Drug Evaluation and Research (CDER)
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`December 1999
`
`Table of Contents
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
`PURPOSE
`I.
`BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
`II.
`III. APPLICABILITY OF THE DISCLOSURE PROCEDURES DESCRIBED IN THIS
`GUIDANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
`ORGANIZATION OF SPONSOR SUBMISSIONS TO ADVISORY COMMITTEE3S
`
`IV.
`
`A.
`B.
`
`C.
`
`Fully Releasable Sponsor Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
`Sponsor Submissions That Contain Material Claimed to be Exempt From
`Disclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
`What is Typically Disclosable and What is Typically Exempt from Disclosure?4
`
`V.
`
`TIMING OF SPONSOR'S ADVISORY COMMITTEE SUBMISSIONS AND CDER
`REVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
`
`A.
`B.
`
`C.
`
`Fully Releasable Sponsor Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
`Sponsor Submissions That Contain Material Designated by the Sponsor as
`Exempt From Disclosure (Marketing Application is Under Standard
`Review) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
`Sponsor Submissions That Contain Material Designated by the Sponsor as
`Exempt From Disclosure (Effect on the Review Clock if Marketing Application
`is Under Priority Review) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
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`Draft -- Not for Implementation
`
`Guidance for Industry1
`
`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
`
`I.
`
`PURPOSE
`
`This document is intended to provide guidance to the sponsors of applications that are the subjects of
`open advisory committee meetings convened by the Center for Drug Evaluation and Research (CDER),
`beginning January 1, 2000. It describes the procedures CDER intends to follow when making publicly
`2
`available the information provided to advisory committee members in connection with such meetings.
`The guidance also describes how a sponsor should prepare its submissions to an advisory committee.
`
`The procedures described in this guidance are intended to make the process of complying with the
`disclosure requirements of the Federal Advisory Committee Act (the FACA) (5 U.S.C. App. 2) 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 CDER, (3) the
`process by which CDER will review and redact the sponsor submission and the related CDER
`submission, and (4) the effect this process may have on the time allotted to a review cycle in which an
`advisory committee meeting occurs.
`
`II.
`
`BACKGROUND
`
`On November 30, 1999 (64 FR 66920), CDER issued a guidance document on the public disclosure
`
`1
` This guidance document represents the Agency’s current thinking on the implementation by the Center
`for Drug Evaluation and Research (CDER) 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 statute and regulations.
`
`2
` This guidance covers the following advisory committees: Anesthetic and Life Support Drugs, Anti-
`Infective Drugs, Antiviral Drugs, Arthritis, Cardiovascular and Renal Drugs, Compounding, Dermatologic and
`Ophthalmic Drugs, Drug Abuse, Endocrinologic and Metabolic Drugs, Reproductive Health Drugs, Gastrointestinal
`Drugs, Generic Drugs, Medical Imaging Drugs, Nonprescription Drugs, Oncologic Drugs, Peripheral and Central
`Nervous System Drugs, Pharmaceutical Science, Psychopharmacologic Drugs, Pulmonary-Allergy Drugs. CDER
`advisory committees that are chartered in the future will also be covered by this guidance.
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`of materials provided to advisory committees in connection with open advisory committee meetings
`convened by CDER on or after January 1, 2000 (Disclosure of Information 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). In
`3
`that document, CDER provided the following interpretation of the Agency’s responsibilities under the
`FACA and of FDA’s regulations governing disclosure of information concerning new drug applications
`in 21 CFR 314.430:
`
`FDA construes the FACA to require that, with respect to any open advisory committee
`meeting convened pursuant to the FACA, whenever practicable and subject to any
`applicable exemptions of the Freedom of Information Act (the FOIA) (5 U.S.C. §
`552), those materials that are provided to the members of an 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. FDA interprets § 314.430 to
`be consistent with the FACA and therefore will exercise its discretion under §
`314.430(d)(1) in a manner consistent with the FACA and the FOIA as described in the
`previous sentence to make available for public inspection and copying materials
`provided to the members of an advisory committee in connection with open advisory
`committee meetings convened by CDER, beginning on January 1, 2000.
`
`CDER will make advisory committee materials available consistent with these principles. CDER has
`developed procedures for ensuring that materials that are provided to advisory committees in
`connection with open advisory committee meetings convened by CDER beginning January 1, 2000, will
`be made publicly available before or at the meeting, whenever practicable. These procedures should
`also ensure that those materials that are exempt from disclosure under the FOIA will not be made
`publicly available. These procedures are designed to minimize the time and resources spent reviewing
`the materials in an advisory committee submission, determining which materials are exempt from
`disclosure under the FOIA, and redacting such materials.
`
`It is necessary to minimize CDER consultation and redaction time because the more time the Agency
`needs to redact materials in advance of an advisory committee meeting, the earlier in the application
`review process the sponsor must prepare its background package for the advisory committee. If the
`preparation of the advisory committee package occurs too early in the review process, the package
`may not adequately address the issues that will be the subject of the advisory committee meeting,
`because those issues will not yet have crystallized.
`
`3
` This document is available from the Drug Information Branch (HFD-210), CDER, 5600 Fishers Lane,
`Rockville, MD 20857, (Tel) (301) 827-4573, http://www.fda.gov/cder/guidance/index.htm.
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`An alternative to setting an earlier date for submission of advisory committee packages to allow for
`adequate review and redaction time is to maintain the current timing of the submission of the advisory
`committee package, but postpone the date of the advisory committee meeting until later in the review of
`the application. This would necessitate, in turn, an extension of the total review time allotted to that
`review cycle. It is therefore critical to keep to a minimum the period of time spent on the process of
`reviewing and redacting an advisory committee package.
`
`III. APPLICABILITY OF THE DISCLOSURE PROCEDURES DESCRIBED IN THIS
`GUIDANCE
`
`Although most advisory committee meetings convened by CDER concern new drug applications
`(NDAs) or NDA supplements, a few may concern abbreviated new drug applications (ANDAs),
`biological license applications (BLAs), or premarket approval applications (PMAs) for devices.
`CDER interprets the disclosure policy guidance to apply to all open advisory committee meetings
`convened by CDER beginning January 1, 2000, where the focus of the meeting solely or primarily
`addresses an NDA, NDA supplement, or ANDA. Therefore, if an unapproved BLA or PMA is being
`discussed at a segregable portion of a CDER advisory committee meeting (for example, during the
`afternoon session), that BLA or PMA will not be subject to the disclosure procedures described in this
`guidance. However, if an unapproved BLA or PMA is being discussed in unison with an NDA (for
`example, a combination product consisting of both a drug and a device), that BLA or PMA will be
`subject to these disclosure procedures to the extent allowed under applicable law.
`
`The procedures outlined in this guidance do not apply to submissions in connection with open advisory
`committee meetings that do not concern the approval or testing of products (the type of meetings that
`involve, for example, postapproval monitoring programs, over-the-counter monograph issues
`concerning the safety of already-marketed products, or general policy/guidance issues) because the
`submissions for such meetings do not generally involve as much redaction as submissions for meetings
`on unapproved products or unapproved new indications for approved products. The procedures in this
`guidance also do not apply to (1) closed advisory committee meetings and (2) open advisory
`committee meetings convened solely by components of FDA other than CDER.
`
`IV.
`
`A.
`
`ORGANIZATION OF SPONSOR SUBMISSIONS TO ADVISORY COMMITTEES
`
`Fully Releasable Sponsor Submissions
`
`To shorten the process of complying with the FACA’s disclosure requirements, 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 asserts is exempt from disclosure under the FOIA
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`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
`including names or other information that would personally identify individual subjects). Sponsors are
`also encouraged to submit an electronic version of the package. A submission that is fully releasable
`(whether hard copy or electronic) should be clearly marked “AVAILABLE FOR PUBLIC
`DISCLOSURE WITHOUT REDACTION” in uppercase, bolded script. Because such a
`submission will not require agency redaction for trade secret and confidential commercial information, it
`may be submitted to CDER closer in time to the advisory committee meeting than a package that
`requires redaction (see section V). This will give the sponsor more time to prepare the submission.
`
`B.
`
`Sponsor Submissions That Contain Material Claimed to be Exempt From Disclosure
`
`If the sponsor believes that it is necessary to include material in an advisory committee submission that it
`believes is exempt from disclosure under the FOIA, the sponsor should:
`
`1. Segregate the material it believes is exempt from the disclosable material, generally by
`placing it in a separate portion of the briefing package. Where that is not possible, the material
`that the sponsor believes is exempt should be designated by a distinct typeface.
`
`2. Clearly designate the material that the sponsor believes is exempt.
`
`3. For each document or portion of a document that the sponsor believes is exempt from
`disclosure, provide a detailed justification explaining (a) why the information is necessary to the
`advisory committee’s consideration of the issues before it and (b) why the sponsor believes the
`information is exempt from disclosure under the FOIA.
`
`Sponsors are also encouraged to submit an electronic version of the package. Following these steps
`will reduce the time CDER must spend determining the exempt status of the materials, consulting with
`the sponsor, and redacting any such exempt material.
`
`C.
`
`What is Typically Disclosable and What is Typically Exempt from Disclosure?
`
`To assist a sponsor in determining which materials in its advisory committee package are likely to be
`considered disclosable under the FOIA, CDER is providing guidance on certain materials that it is
`unlikely to consider confidential commercial or trade secret information exempt from disclosure under
`Exemption 4 of the FOIA.
`
`In general, summaries of safety and effectiveness data will be disclosed. Although full reports of safety
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`and effectiveness data might be used by a competitor to support approval of a competing product, a
`summary could not be so used and, therefore, generally does not constitute confidential commercial
`information.
`
`Although some of the other materials from an application listed below might be considered confidential
`commercial information at earlier stages of the drug development process, CDER believes that it is
`appropriate to make them available under §314.430(d)(1) at the time of an advisory committee meeting
`if they are germane to the issues to be discussed at the meeting. In general, these materials are often
`necessary to permit consideration of the safety and effectiveness of an unapproved application before
`an advisory committee and are routinely discussed by the advisory committee and the sponsor at an
`open advisory committee meeting. Sponsors of applications generally know that when their
`unapproved applications go before an open advisory committee, the information contained in the
`materials listed below will often be the subject of open discussion.
`
`Ordinarily, the following materials in advisory committee packages will be considered disclosable,
`unless they contain information that the sponsor demonstrates will cause substantial competitive harm if
`disclosed:
`
`1. Summary tables of safety and effectiveness data
`
`2. Summaries of clinical or non-clinical safety or effectiveness data
`
`3. Summaries of suspected adverse drug reaction data
`
`4. Statistical summaries of safety and effectiveness data
`
`5. Clinical or preclinical protocols
`
`6. Copies of slides to be presented by the sponsor at the advisory committee meeting
`
`7. Names of principal investigators
`
`8. Proposed INDICATIONS FOR USAGE, DOSAGE AND ADMINISTRATION, and
`safety sections of product labeling
`
`9. Any other information that has been previously publicly disclosed by the sponsor
`
`Ordinarily, the following materials in advisory committee packages will be considered trade secret or
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`confidential commercial information that is exempt from disclosure under the FOIA:
`
`1. Product formulation and other chemistry, manufacturing, and controls (CMC) information
`
`2. Full reports of raw clinical or preclinical data4
`
`3. Reports of unpublished studies
`
`These lists are neither exhaustive nor absolute and should be considered broad guidance to aid
`sponsors in their submissions and CDER in its redaction of advisory committee briefing packages.
`
`Regardless of whether a sponsor submits a package that it designates as fully releasable, CDER
`cautions that submissions should include only information that accurately reports data that support the
`application and are directly relevant to the issues being discussed at the meeting. Statements or
`suggestions that could be viewed as misleading or promotional (e.g., statements that go beyond the
`study conclusions or speculate about clinical or commercial implications not supported by the data or
`not the subject of the advisory committee meeting) are inappropriate for inclusion in the package. In an
`effort to avoid any misunderstanding that CDER has endorsed the contents of a sponsor package by
`posting it on the Agency’s website (see section V), the following notice will accompany each set of
`briefing materials placed on the FDA website: “The statements contained in this document are those of
`the product’s sponsor, not FDA, and FDA does not necessarily agree with the sponsor’s statements.
`FDA has not made a final determination about the safety or effectiveness of the product described in
`this document.” CDER also reserves the right to take appropriate action to address any information that
`may be promotional or misleading, including posting a correction on the Agency’s website.
`
`V.
`
`TIMING OF SPONSOR'S ADVISORY COMMITTEE SUBMISSIONS AND CDER
`REVIEW
`
`CDER has developed the following timelines for submission and redaction of materials provided to
`CDER advisory committees in connection with open advisory committee meetings convened by CDER
`to discuss the testing of products or to discuss unapproved applications (including efficacy supplements
`to approved applications) to market products.
`
`CDER notes that the timelines do not provide for formal predisclosure notification of sponsors pursuant
`to 21 CFR 20.61(e) and (f). The predisclosure notification requirements in that section apply only
`
`4
` For the purposes of this guidance, CDER considers data to be “raw data” if they are presented by
`individual subject. Data that summarize or average multiple subject outcomes/results are considered summaries.
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`where the disclosure is to be made in response to a specific request for Agency records. The
`disclosures contemplated here are not made in response to such a request, but to comply with the
`FACA. Nevertheless, the time frames are at least as generous as the time frames for notification of
`sponsors under 21 CFR 20.61.
`
`This guidance document constitutes public notice under 21 CFR 14.35(d)(2) that a sponsor package
`should be submitted within the time frames listed below if it is to be considered by a CDER advisory
`committee. If a submission from a sponsor is not received by CDER within the time frames listed
`5
`below, it will not be forwarded to the committee and will not be considered by the committee. In the
`time frames, business day means a day that FDA is officially open for business.
`
`A.
`
`Fully Releasable Sponsor Submissions
`
`By close of business (COB) 22 business days prior to the advisory committee meeting,
`the sponsor should submit its background package to the CDER Advisors and
`Consultants Staff (ACS).
`
`By COB 21 business days prior to the advisory committee meeting, ACS will send the
`sponsor package to committee members by overnight mail and to the CDER review
`division(s).
`
`By COB 19 business days prior to the advisory committee meeting, the CDER review
`division(s) should submit its background package to ACS.
`
`By COB 18 business days prior to the advisory committee meeting, ACS will send the
`CDER background package to the CDER Freedom of Information (FOI) staff for
`redaction review.
`
`By COB 18 business days prior to the advisory committee meeting, ACS will send the
`complete (i.e., unredacted) CDER background package to the committee members by
`overnight mail.
`
`By COB 15 business days prior to the advisory committee meeting, the FOI staff will
`submit to ACS a redacted version (if any) of the CDER background package.
`
`By COB 14 business days prior to the advisory committee meeting, ACS will send to
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`5
`
`See footnote 2 for a list of CDER advisory committees.
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`7.
`
`8.
`
`9.
`
`10.
`
`the sponsor by overnight mail a copy of the redacted version of the CDER background
`package.
`
`By COB 8 business days prior to the advisory committee meeting, final discussions with
`the sponsor on redaction of exempt materials from the CDER package will be
`completed.
`
`By COB 7 business days prior to the advisory committee meeting, CDER will fax and
`send to the sponsor by overnight mail a letter stating CDER’s final decision on
`redaction of material from the CDER package.
`
`By COB 7 business days prior to the advisory committee meeting, the sponsor
`package and CDER’s redacted package will be submitted by ACS to the Dockets
`Management Branch for preparation for posting on the FDA website.
`
`1 business day prior to the advisory committee meeting (24 hours prior to meeting),
`FDA will post on its website the sponsor package and CDER’s redacted package. If
`FDA is unable to post the package on its website prior to the meeting, the two
`packages will be made publicly available at the location of the advisory committee
`meeting, and the two packages will be posted on the Agency website after the meeting.
`Sponsors are encouraged to bring to the meeting, for public distribution, a reasonable
`number of hard copies of the slides they will be presenting.
`
`B.
`
`Sponsor Submissions That Contain Material Designated by the Sponsor as Exempt
`From Disclosure (Marketing Application is Under Standard Review)
`
`1.
`
`2.
`
`By COB 48 business days before the advisory committee meeting, the sponsor should
`submit to ACS two versions of its background package: a complete (unredacted)
`version and a redacted version. In the complete version, the material the sponsor
`believes to be exempt from disclosure should be segregated and clearly marked and
`should be accompanied by the justification described in section IV above for each
`document or portion of a document the sponsor asserts is exempt. In the redacted
`version, the material that the sponsor believes is exempt should be deleted. Three
`copies of each version of the background package should be submitted to ACS.
`
`By COB 47 business days before the advisory committee meeting, ACS will send one
`copy of the sponsor's submission to the FOI staff and one copy to the appropriate
`review division(s).
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`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Draft -- Not for Implementation
`
`By COB 35 business days prior to the advisory committee meeting, CDER will fax and
`send to the sponsor a letter stating which materials it believes should be redacted from
`the sponsor package.
`
`By COB 30 business days prior to the advisory committee meeting, final discussions
`with the sponsor on redaction of materials from the sponsor package will be completed.
`
`By COB 28 business days prior to the advisory committee meeting, CDER will fax and
`send to the sponsor by overnight mail a letter stating CDER’s final position on redaction
`of material from the sponsor package. The sponsor then has 5 business days in which
`to decide whether to remove any materials that CDER has determined will not be
`redacted if the background package is ultimately submitted for committee review and to
`reformat the submission accordingly. No new materials for possible redaction may be
`added to the package during this period.
`
`By COB 22 business days prior to the advisory committee meeting, the sponsor’s
`complete and redacted final package FOR ADVISORY COMMITTEE REVIEW
`should be submitted to ACS. It should be made clear to CDER what materials that
`were originally in the package have been removed, if any. The sponsor should submit
`the unredacted package and the redacted package to ACS.
`
`By COB 21 business days prior to the advisory committee meeting, ACS will send the
`sponsor’s final unredacted background package to the committee members by
`overnight mail and to the CDER review division(s).
`
`By COB 19 business days prior to the advisory committee meeting, the CDER review
`division should submit its background package to ACS.
`
`By COB 18 business days prior to the advisory committee meeting, ACS will send the
`CDER background package to the FOI staff for redaction review.
`
`By COB 18 business days prior to the advisory committee meeting, ACS will send the
`complete (i.e., unredacted) CDER background package to the committee members by
`overnight mail.
`
`10.
`
`By COB 15 business days prior to the advisory committee meeting, the FOI staff will
`submit to ACS a redacted version (if any) of the CDER background package.
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`11.
`
`12.
`
`13.
`
`14.
`
`15.
`
`By COB 14 business days prior to the advisory committee meeting, ACS will send to
`the sponsor by overnight mail a copy of the redacted version of the CDER background
`package.
`
`By COB 8 business days prior to the advisory committee meeting, final discussions with
`the sponsor on redaction of exempt materials from the CDER package will be
`completed.
`
`By COB 7 business days prior to the advisory committee meeting, CDER will fax and
`send by overnight mail a letter stating CDER’s final decision on redaction of material
`from the CDER package.
`
`By COB 7 business days prior to the advisory committee meeting, the final redacted
`sponsor package and CDER’s redacted package will be submitted by ACS to the
`Dockets Management Branch for preparation for posting on the FDA website
`
`1 business day prior to the advisory committee meeting (24 hours prior to meeting),
`FDA will post on its website the sponsor’s redacted package and CDER’s redacted
`package. If FDA is unable to post the packages on its website prior to the meeting, the
`two packages will be made publicly available at the location of the advisory committee
`meeting, and the two packages will be posted on the Agency website after the meeting.
`Sponsors are encouraged to bring to the meeting, for public distribution, a reasonable
`number of hard copies of the slides they will be presenting.
`
`C.
`
`Sponsor Submissions That Contain Material Designated by the Sponsor as Exempt
`From Disclosure (Effect on the Review Clock if Marketing Application is Under
`Priority Review)
`
`When the product being discussed at an advisory committee meeting covered by this guidance is a
`product that is the subject of a marketing application that is under priority review by CDER, the
`process for handling a sponsor package that the sponsor asserts contains materials to be redacted will
`be handled within the same time frames and expectations described in Section B of this guidance.
`However, such a submission will be considered an agreement by the sponsor to extend by 2 months the
`review time for the review cycle in which the advisory committee meeting will be held.
`
`J:\!GUIDANC\3479DFT.WPD
`12/16/99
`
`10
`
`RCT2163
`KRT!qh!W/U/!Rcvgpv!Pq/!9-842-;74
`Rcig!24!qh!25
`
`

`
`RCT2163
`KRT!qh!W/U/!Rcvgpv!Pq/!9-842-;74
`Rcig!25!qh!25