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- 3. ACs Should Convene When: S The Commissioner thinks it is in the public interest S Review of a performance standard for an electronic product by the Technical Electronic Product RadiaSon Safety Standards CommiDee (TEPRSSC) S Review of safety of color addiSves S Review safety and efficacy of human rx drugs or OTCs
- 4. ACs Should Convene When: S Review safety and efficacy of biological drugs S ClassificaSon of devices S Establish, amend, or revoke a device performance standard S Review device premarket approval applicaSons and product development protocols S Review of device good manufacturing pracSce regulaSons S Person requests a hearing before an AC in lieu of a formal evidenSary public hearing
- 5. AC Guidelines S Can be standing or ad hoc S May be a policy AC or a technical AC S An AC includes any of its subgroups when the subgroup is working on behalf of the AC S Cannot be composed enSrely of full-Sme Federal Government Employees S Fixed membership, defined purpose, periodic meeSngs, and organizaSonal structure
- 9. What is NOT an AC? S Group convened on an ad hoc basis to discuss maDer of current FDA interest S No conSnuing funcSon S No substanSal special preparaSon S Two or more FDA consultants meeSng with the agency on an ad hoc basis S Group of experts employed by a private company/trade associaSon providing its views on a regulatory maDer that is before the FDA S ConsulSng firm hired by the FDA to provide advice
- 10. What is NOT an AC? S One or two FDA consultants who are special Government employees on an internal FDA commiDee S A Public Board of Inquiry or other similar group convened by agreement between the parSes to a regulatory proceeding pending before FDA to review and prepare an iniSal decision on the issues in lieu of a formal evidenSary public hearing S AcSng as an administraSve law tribunal and is not an advisory commiDee
- 11. What is NOT an AC? S An open public conference or meeSng S An FDA commiDee that primarily has operaSonal responsibility rather than that of providing advice and recommendaSons S Ex: Research Involving Human Subjects CommiDee (RIHSC) • TEPRSSC and ACs established under the Medical Device Amendments of 1976 specific statutes require its existence
- 15. Person Claiming Noncompliance by an AC S If the person objects to any acSon, the person shall submit a peSSon S Includes failure to act S Does not include denial of access to an AC document S If the acSon by an AC is in the past: S Submit the peSSon within 30 days acer the acSon objected to S The Commissioner will grant any appropriate relief and take steps to prevent its future recurrence
- 16. Person Claiming Noncompliance by an AC S If the acSon by an AC is proposed to be in the future: S The Commissioner will expedite the review of the peSSon and make a reasonable effort to render a decision before the acSon concerned in the peSSon S If the acSon by the AC is imminent or occurring: S The maDer may be handled by an oral peSSon in lieu of a wriDen peSSon S Ex: the closing of a porSon of a meeSng which is made known for the first Sme on the day of the meeSng S If it is denial of access to an AC document: S AdministraSve review is in accordance with the procedures established by the Department of Health and Human Services
- 18. AC or non-AC CommiDee? S FDA may enter into contracts with independent scienSfic or technical organizaSons to obtain advice and recommendaSons on parScular maDers S Whether a parScular commiDee working under such a contract is an advisory commiDee depends on FACA S This subpart depends upon applicaSon of the criteria and principles in §14.1(b) (Guidelines for an AC)
- 20. Timeframe S Before the first of each month S At least 15 days before the meeSng S Commissioner will publish a noSce in the FEDERAL REGISTER of all AC meeSng is to be held during the month S Any AC meeSngs for that month called acer the general monthly noSce are to be announced in the FEDERAL REGISTER on an individual basis at least 15 days in advance S The Commissioner may authorize an excepSon to these noSce requirements in an emergency or for other reasons requiring an immediate meeSng of an advisory commiDee
- 22. FEDERAL REGISTER NoSce S Time set aside for oral statements/public parScipaSon S Name, address and telephone number for the AC DFO and any other agency employee designated as responsible for the administraSve support for the AC S Statement that wriDen submissions may be made to the DFO at any Sme S Unless a cutoff date is established
- 23. FEDERAL REGISTER NoSce S An explanaSon for lateness of a noSce if it is published less than 15 days before a meeSng in the FEDERAL REGISTER S If a public hearing before an AC is used in lieu of a formal evidenSary public hearing an iniSal noSce of hearing is to be published separately in the FEDERAL REGISTER S This procedure may be used for any other hearing before an AC when the Commissioner concludes, that it would be informaSve to the public S A list of AC meeSngs will be distributed to the press by the Associate Commissioner for Public Affairs
- 25. When a MeeSng can be Held S In the presence of the DFO with advance approval of the agenda S No meeSng may be held in the absence of the DFO S If a maDer is added to the agenda acer it is published in the FEDERAL REGISTER: S ADempt is to be made to inform persons known to be interested in the maDer S The change is to be announced at the beginning of the open porSon of the meeSng
- 26. LogisScs S Advisory commiDee meeSngs will be held at places that are reasonably accessible to the public S Washington, DC S Rockville, MD S Unless the Commissioner receives and approves a wriDen request from the AC for a different locaSon S Whenever feasible, meeSngs are to be held in government faciliSes or other faciliSes involving the least expense to the public S The size of the meeSng room is to be reasonable, considering such factors as: S Size of the commiDee S Number of persons expected to aDend a meeSng S Resources and faciliSes available
- 27. LogisScs S A different locaSon may be approved when one or more of the following applies: S The total cost of the meeSng to the Government will be reduced S A substanSal number of the commiDee members will be at the locaSon at no expense to FDA for other reasons S It is a central locaSon more readily accessible to commiDee members S There is a need for increased parScipaSon available at that locaSon S The commiDee wishes to review work or faciliSes in a specific locaSon S The commiDee is concerned with maDers that funcSonally or historically occur in some other locaSon
- 28. LogisScs S A quorum for an AC is a majority of the current voSng members of the commiDee S Any maDer before the AC is to be decided by a majority vote of the voSng members present at the Sme S Except the DFO may require that any final report be voted upon by all current voSng members of the commiDee S Any current voSng member of the commiDee may file a separate report with addiSonal or minority views S If space is available, any interested person may aDend any porSon of any AC meeSng which is not closed
- 29. LogisScs S The Commissioner may authorize a meeSng to be held by conference telephone call S A speaker phone will be provided in a conference room located in Washington, DC, or Rockville, MD, or the immediate vicinity S To permit public parScipaSon in open porSons of the meeSngs S For the purpose of taking final votes or otherwise confirming acSons taken by the commiDee at other meeSngs not permit a meeSng to be held at a central locaSon
- 31. Reports and Discussions S Any commiDee member may take notes during meeSngs and report and discuss commiDee deliberaSons a+er a meeSng is completed and before official minutes or a report are available S Within FDA rules and regulaSons: S No aDribuSon of individual views expressed in a closed session or revealing of numerical votes S No reporSng or discussion of any parScular maDer if the commiDee or FDA specifically so directs S Ex: where deliberaSons are incomplete or involve a sensiSve regulatory decision that requires preparaSon or implementaSon S No reporSng or discussion of informaSon prohibited from public disclosure S Notes or minutes kept or reports prepared by a commiDee member have no status or effect unless adopted into the official minutes or report by the commiDee
- 34. Open CommiDee Discussion S A commiDee discusses any maDer pending before it in an open porSon of its meeSng unless the meeSng has been closed for that maDer S To the maximum extent feasible, a commiDee conducts its discussion of pending maDers in an open porSon S No public parScipaSon is permissible during this porSon of the meeSng except with the consent of the commiDee Chairperson
- 38. Decision to Close S No commiDee meeSng may be enSrely closed S A porSon of a meeSng may be closed only in accordance with a wriDen determinaSon by the Commissioner under this secSon S The DFO or other designated agency employee shall prepare the iniSal request for a determinaSon to close a porSon of a meeSng S Specifying the maDer(s) to be discussed during the closed porSon S Reasons why the porSon should be closed S The Commissioner, with the concurrence of the Chief Counsel, will determine whether to close a porSon of a meeSng
- 39. Decision to Close S The reasons for closing a porSon of a meeSng will be announced in the FEDERAL REGISTER noSce of the meeSng: S Any determinaSon to close a porSon of a meeSng restricts the closing to the shortest possible Sme consistent with the policy in this secSon S A porSon of a meeSng may be closed only if the Commissioner determines that the closing is permiDed S PorSons of meeSngs may ordinarily be closed if they concern the review, discussion, and evaluaSon of dracs or regulaSons, guidance documents or similar preexisSng internal agency documents, but only if their premature disclosure would significantly impede proposed agency acSon; review of trade secrets and confidenSal commercial or financial informaSon
- 40. Decision to Close S The reasons for closing a porSon of a meeSng will be announced in the FEDERAL REGISTER noSce of the meeSng: S PorSons of meeSngs ordinarily may not be closed if they concern review, discussion, and evaluaSon of general preclinical and clinical test protocols and procedures for a class of drugs or devices; consideraSon of labeling requirements for a class of marketed drugs and devices; review of informaSon on specific invesSgaSonal or marketed drugs and devices that have previously been made public; presentaSon of any other informaSon not exempt from public disclosure S A maDer which is normally open may be closed only if it is so inextricably intertwined with maDers to be discussed in a closed porSon that it is not feasible to separate them or discussion of the maDer in an open porSon would compromise the maDers to be discussed in the closed porSon
- 41. ADendance S A porSon of a meeSng closed for the presentaSon or discussion of informaSon that consStutes a trade secret or confidenSal commercial or financial informaSon may be aDended only by: S VoSng AC members S NonvoSng members represenSng consumer interests who are also SGEs S DFO of the AC S Transcriber S Consultants S Other regular employees of FDA (including members of the Office of the Chief Counsel) as the Chairperson of the AC may invite, and by those persons authorized to be present S A person making a presentaSon described in §14.25(c) may be accompanied by a reasonable number of employees, consultants, or other persons in a commercial arrangement
- 42. ADendance S A porSon of a meeSng that has been closed for consideraSon of exisSng internal agency documents where premature disclosure is likely to significantly impede: S Proposed agency acSon S Personnel, medical, and similar files S Disclosure of which would be a clearly unwarranted invasion of personal privacy S InvesSgatory records compiled for law enforcement purposes May be aDended only by: S CommiDee members (voSng and nonvoSng), S DFO of the commiDee, S Transcriber S Other regular employees of FDA (including members of the Office of the Chief Counsel) whom the Chairperson of the commiDee may invite. S Consultants, individuals performing personal service contracts, employees of other Federal agencies, and the general public may not aDend such porSons
- 43. ADendance S If a person aDempts to aDend a closed porSon of a meeSng without the approval of the DFO and the Chairperson, the person will be required to leave the meeSng immediately S This does not enable other unauthorized persons to aDend, nor does it, consStute grounds for release of transcripts of closed porSons or any other documents otherwise exempt from disclosure S If a person is allowed by the DFO and the Chairperson to aDend a closed porSon of a meeSng, that porSon is open to aDendance by any interested person
- 45. Open Hearing S The open porSon for public parScipaSon, which consStutes a public hearing will be at least 1 hour S Unless public parScipaSon does not last that long S May last for whatever longer Sme the commiDee Chairperson determines will facilitate the work of the commiDee S The FEDERAL REGISTER noSce will designate the Sme specifically reserved for the hearing S Ordinarily the first porSon of the meeSng S Further public parScipaSon in any open porSon of the meeSng is solely at the discreSon of the Chairperson S Ex: Open CommiDee Discussion
- 46. Oral PresentaSons S An interested person who wishes to be assured of the right to make an oral presentaSon at a meeSng will inform the DFO or other designated agency employee, before the meeSng S Orally or in wriSng S The person shall state the general nature of the presentaSon and the approximate Sme desired S Whenever possible, all wriDen informaSon to be discussed by that person at the meeSng should be given in advance to the DFO S This material may be distributed or mailed by FDA to the commiDee members in advance of the meeSng if Sme permits S Otherwise will be distributed to the members when they arrive for the meeSng S The mailing or distribuSon may be undertaken only by FDA unless FDA grants permission to a person to mail or distribute the material
- 47. Oral PresentaSon S Before the meeSng, the DFO or other designated agency employee shall determine the amount of Sme allocated to each person for oral presentaSon and the Sme that the presentaSon is to begin S Each person will be so informed in wriSng or by telephone S FDA may require persons with common interests to make joint presentaSons
- 48. Procedures S The Chairperson of the commiDee shall preside at the meeSng and be accompanied by other commiDee members, who serve as a panel in conducSng the hearing porSon of the meeSng S Each person may use the alloDed Sme as desired, consistent with an orderly hearing S A person may be accompanied by addiSonal persons, and may present any wriDen informaSon or views for inclusion in the record of the hearing
- 49. Procedures S If a person is absent at the Sme specified for that person's presentaSon, the persons following will appear in order S An aDempt will be made to hear the person at the conclusion of the hearing S Interested persons aDending the hearing who did not request an opportunity to make an oral presentaSon may be given an opportunity to do so at the discreSon of the Chairperson
- 50. Procedures S The Chairperson and other members may quesSon a person concerning that person's presentaSon S No other person may quesSon the person S The Chairperson may allot addiSonal Sme when it is in the public interest, but may not reduce the Sme alloDed without consent of the person S ParScipants may quesSon a commiDee member only with that member's permission and only about maDers before the commiDee S The hearing is informal, and the rules of evidence do not apply S No moSons or objecSons relaSng to the admissibility of informaSon and views may be made or considered, but other parScipants may comment upon or rebut maDers presented S No parScipant may interrupt the presentaSon of another parScipant
- 52. Who may a CommiDee Confer With? S Any person who may have informaSon or views relevant to any maDer pending before the commiDee S A person who is not a Federal Government execuSve branch employee only during the open porSons of a meeSng S The person may submit views in wriSng to the commiDee as part of the administraSve record S The person may parScipate at the closed porSons of a meeSng only if appointed as an SGE by the Commissioner
- 53. Who may NOT a CommiDee Confer With? S Federal execuSve branch employees who are not employees of the Department may not confer, tesSfy, or otherwise parScipate (other than as observers) at any porSon of an AC meeSng unless they are appointed as SGEs by the Commissioner S To prevent inadvertent violaSon of Federal conflict of interest laws and laws prohibiSng disclosure of trade secrets S Does not apply to Federal execuSve branch employees who are appointed as members of TEPRSSC
- 54. Consultants S The Commissioner may appoint persons as SGEs to be consultants to an AC S Consultants may be appointed to provide experSse, generally concerning a highly technical maDer, not readily available from the members of the commiDee S Consultants may be either from outside the Government or from agencies other than the FDA S Reports, data, informaSon, and other wriDen submissions made to a public AC by a consultant are part of the administraSve record
- 56. Materials S All applicable conflict of interest laws and regulaSons and a summary of their principal provisions S All applicable laws and regulaSons relaSng to trade secrets and confiden:al commercial or financial informaSon that may not be disclosed publicly and a summary of their principal provisions S All applicable laws, regulaSons, and guidance documents rela:ng to the subject ma?er covered by AC and a summary of their principal provisions S All applicable laws, regulaSons, including the regulaSons in part 20 of this chapter, AC charters, FEDERAL REGISTER noSces, curricula vitae, rules adopted by the AC, and other material rela:ng to the forma:on, composi:on, and opera:on of the AC, and a summary of their principal provisions S InstrucSons on whom to contact when quesSons arise S Other material relaSng to FDA and the subject maDer covered by the commiDee which may facilitate the work of the commiDee
- 58. Procedures S Ten copies of wriDen submissions to a commiDee are to be sent to the DFO S Unless an applicable FEDERAL REGISTER noSce or other regulaSons in this chapter specify otherwise S Submissions are subject to the provisions of §10.20 (Submission of Documents to Division of Dockets Management; ComputaSon of Time; Availability for Public Disclosure) S It is not necessary to send copies to the Division of Dockets Management
- 60. Procedures S At the request of a commiDee, or on the Commissioner's own iniSaSve, the Commissioner may at any Sme request the applicant or sponsor of an applicaSon or peSSon about a specific product on which acSon is pending before FDA, and is being reviewed by an AC, to present or discuss safety, effecSveness, or other data concerning the product during a regularly scheduled meeSng of the commiDee S The request may be for an oral presentaSon or for a concise, well- organized wriDen summary S Unless specified otherwise, a proposed agenda outlining the topics to be covered and idenSfying the parScipaSng industry staff members or consultants that will present each topic is to be submiDed to the DFO at least 3 weeks before the meeSng
- 61. Procedures S An interested person may submit to a commiDee wriDen informaSon or views on any maDer being reviewed S Voluminous data is to be accompanied by a summary S A submission is to be made to the DFO and not directly to a commiDee member S FDA will distribute submissions to each member, either by mail or at the next meeSng S Submissions will be considered by the commiDee in its review of the maDer S A commiDee may give public noSce of a cutoff date acer which submissions about a maDer will no longer be received or considered
- 67. Establishment S The Commissioner will issue a FEDERAL REGISTER noSce cerSfying that the establishment or renewal is in the public interest and staSng: S Structure S FuncSon S Purposes S If it is a standing AC, shall amend §14.100 (List of Standing ACs) to add it to the list of standing advisory commiDees S A noSce of establishment will be published at least 15 days before the filing of the AC charter
- 69. Establishment Rules S No commiDee may meet or take acSon unSl its charter is prepared and filed as required S This requirement is to be met by an AC uSlized by FDA, even though it is not established by the agency, prior to uSlizaSon S The charter of a parent commiDee may incorporate informaSon concerning acSviSes of a subgroup S In such instances, a subgroup will not be established as a commiDee disSnct from the parent commiDee S A subgroup will be established as a separate commiDee when: S The charter of the parent commiDee does not incorporate the acSviSes of the subgroup S The subgroup includes members who are not all drawn from the parent commiDee
- 71. AC Required Standards • Its purpose is clearly defined S Its membership is balanced fairly in terms of the points of view represented in light of the funcSons to be performed S AC members are selected without regard to race, color, naSonal origin, religion, age, or sex S It is consStuted and uSlizes procedures designed to assure that its advice and recommendaSons are the result of the AC’s independent judgment S Its staff is adequate S The Commissioner designates an DFO and alternate for every AC (who are employees of FDA) S The DFO is responsible for all staff support unless other agency employees are designated for this funcSon S Whenever feasible (or required by statute) it includes representaSves of the public interest
- 73. TerminaSon S A standing AC is terminated when it is no longer needed, or not later than 2 years acer its date of establishment unless it is renewed for an addiSonal 2-year period S FDA will issue a FEDERAL REGISTER noSce announcing the reasons for terminaSng a commiDee and, if it is a standing commiDee, amending §14.100 (Standing CommiDees) to delete it from the list S This does not apply to permanent statutory ACs