[Federal Register Volume 63, Number 222 (Wednesday, November 18, 1998)]
[Rules and Regulations]
[Pages 63978-63982]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-30812]



[[Page 63978]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. 98N-0361]


Administrative Practices and Procedures; Internal Review of 
Decisions

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations governing the internal review of agency decisions by 
inserting a statement that sponsors, applicants, or manufacturers of 
drugs (including human drugs, animal drugs, and human biologics) or 
devices may request review of a scientific controversy by an 
appropriate scientific advisory panel, or advisory committee. This 
amendment implements the ``Dispute Resolution'' provision of the Food 
and Drug Administration Modernization Act (FDAMA). This document is 
intended to clarify that sponsors, applicants, or manufacturers of 
drugs, or devices may request review of scientific controversies by an 
appropriate scientific advisory panel or advisory committee.

EFFECTIVE DATE: December 18, 1998.

FOR FURTHER INFORMATION CONTACT:
    For information regarding this final rule: Suzanne M. O'Shea, 
Office of the Chief Mediator and Ombudsman (HF-7), Food and Drug 
Administration, 5600 Fishers Lane, rm. 14-105, Rockville, MD 20857, 
301-827-3390.
    For information about requesting section 404 of FDAMA (21 U.S.C. 
360bbb-1) reviews in the Center for Biologics Evaluation and Research: 
Rebecca A. Devine, Associate Director for Policy, Center for Biologics 
Evaluation and Research (HFM-001), Food and Drug Administration, 1401 
Rockville Pike, suite 200 North, Rockville, MD 20852-1448, 301-827-
0373, or
    For information about requesting section 404 reviews in the Center 
for Devices and Radiological Health: James G. Norman, Senior Policy 
Analyst-Acting Ombudsman, Center for Devices and Radiological Health 
(HFZ-001), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-4690, or
    For information about requesting section 404 reviews in the Center 
for Drug Evaluation and Research: Murray M. Lumpkin, Deputy Director 
for Review Management, Center for Drug Evaluation and Research (HFD-
002), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5400, or
    For information about requesting section 404 reviews in the Center 
for Veterinary Medicine: Marcia K. Larkins, Ombudsman, Center for 
Veterinary Medicine (HFV-230), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0137.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, President Clinton signed into law FDAMA (Pub. 
L. 105-115). Section 404 of FDAMA amends the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 301 et seq.) by adding a new 
provision, Dispute Resolution (section 562 of the act (21 U.S.C. 
360bbb-1)). The dispute resolution provision states that:
    If, regarding an obligation concerning drugs or devices under 
this Act or section 351 of the Public Health Service Act, there is a 
scientific controversy between the Secretary and a person who is a 
sponsor, applicant, or manufacturer and no specific provision of the 
Act involved, including a regulation promulgated under such Act, 
provides a right of review of the matter in controversy, the 
Secretary shall, by regulation, establish a procedure under which 
such sponsor, applicant, or manufacturer may request a review of 
such controversy, including a review by an appropriate scientific 
advisory panel described in section 505(n) or an advisory committee 
described in section 515(g)(2)(B). Any such review shall take place 
in a timely manner. The Secretary shall promulgate such regulations 
within 1 year after the date of the enactment of the Food and Drug 
Administration Modernization Act of 1997.
    Section 404 of FDAMA requires FDA to create a procedure to resolve 
scientific controversies if no other mechanism for resolving the 
dispute is contained in the act or regulations issued under the act. 
The act and agency regulations currently set forth many varied 
processes that regulated industry may use to resolve disputes under 
certain specified circumstances. In addition to these specific 
processes, Sec. 10.75 (21 CFR 10.75) provides that any interested 
person may obtain review of any agency decision by raising the matter 
with the supervisor of the employee who made the decision. If the issue 
is not resolved at the supervisor's level, the interested person may 
request that the matter be reviewed at the next higher supervisory 
level. This process may continue through the agency's entire 
supervisory chain of command through the Centers to the Deputy 
Commissioner for Operations, and then to the Commissioner of Food and 
Drugs (the Commissioner).
    FDA's formal processes are supplemented by several ombudsman 
offices to facilitate the resolution of disputes informally. The Office 
of the Chief Mediator and Ombudsman has been established within the 
Commissioner's Office to resolve intercenter disputes, disputes that 
have gone through the Center Directors but are still at issue, or other 
disputes where the complainant has concerns about raising the issue 
with a Center. Several FDA Centers have established Center Ombudsman's 
offices to resolve disputes most appropriately handled at the Center 
level. For further information about any FDA ombudsman office, contact 
the information contact persons listed previously.
    In the Federal Register of June 16, 1998 (63 FR 32733 and 32772), 
FDA published a direct final rule and a companion proposed rule 
amending Sec. 10.75 to add another method of resolving scientific 
controversies in light of section 404 of FDAMA. This amendment stated 
that sponsors, applicants, or manufacturers of drugs (including human 
drugs, animal drugs, and human biologics), or devices may request 
review of scientific controversies by an appropriate scientific 
advisory panel or advisory committee. (Hereafter in this document, the 
term advisory committee includes scientific advisory panels.) By this 
amendment, FDA clarified that sponsors, applicants, and manufacturers 
of drugs, biologics, and devices are not limited solely to requesting 
internal supervisory review, but also have the right to request review 
of scientific controversies by appropriate advisory committees. FDA 
believes that in appropriate circumstances, advisory committees can 
provide the agency with useful insight and advice about the resolution 
of scientific controversies.
    FDA initially used the direct final rule approach to rulemaking 
because it believed the amendment to Sec. 10.75 was noncontroversial 
and in accord with FDAMA. In accordance with FDA's procedures for 
direct final rulemaking, the direct final rule stated that if FDA 
received no significant adverse comments, the direct final rule would 
go into effect on October 29, 1998. The direct final rule stated 
further that if FDA received any significant adverse comments, it would 
withdraw the direct final rule and consider all comments received on 
the companion proposed rule in the development of a final rule

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using the usual notice and comment rulemaking procedures. The comment 
period for the companion proposed rule ended on August 31, 1998. FDA 
received significant adverse comments in response to the direct final 
rule and the companion proposed rule. Therefore, in the Federal 
Register of September 23, 1998 (63 FR 50757), FDA withdrew the direct 
final rule.
    The essence of the significant adverse comments was that the 
amendment to Sec. 10.75 failed to provide a procedure that sponsors, 
applicants, and manufacturers could follow to request section 404 
reviews. The comments suggested that the regulation called for by 
section 404 of FDAMA contain information such as the process for 
selecting members of an advisory committee convened to conduct a 
section 404 review, the timeframes for conducting the reviews, the 
standards for granting or denying a section 404 review, and the weight 
to be given to advisory committee recommendations.
    FDA acknowledges the usefulness of much of this kind of 
information, but concludes that it should not be included in 
Sec. 10.75. Because of the significant differences among FDA Centers in 
applicable laws, existing appeal and dispute resolution mechanisms, and 
approaches to advisory committee management, FDA is adopting a Center-
based approach to the implementation of section 404 of FDAMA. Each 
affected Center is responsible for developing and administering its own 
processes for handling requests for section 404 reviews and is issuing 
a guidance document containing specific information of the type 
suggested by the comments. The substantive differences in the programs 
in the affected Centers, and the different matters that could be the 
subject of a request for advisory committee review, preclude inclusion 
of this type of information in Sec. 10.75.
    In this final rule, information that is applicable to all requests 
for section 404 review has been added to the language amending 
Sec. 10.75. It is expected that Centers will fully evaluate each 
request for section 404 review, and will not unreasonably deny a 
sponsor, applicant, or manufacturer such review. The amendment to 
Sec. 10.75 now provides that if a Center denies a request for section 
404 review, the reason(s) for such denial will be set forth in writing 
to the requester. A Center's decision to deny section 404 review may be 
reviewed through the agency's supervisory chain of command, to the 
Deputy Commissioner for Operations, then to the Commissioner. Persons 
should ordinarily exhaust Center mechanisms for appealing denials of 
section 404 review before seeking review by the Deputy Commissioner. 
Denial of a request for section 404 review is not final agency action 
subject to judicial review.
    Section 10.75 provides that requests for reviews of Center denials 
be submitted to the Chief Mediator and Ombudsman who shall, by informal 
means, facilitate the review of the denial on behalf of the Deputy 
Commissioner for Operations. The role of the Chief Mediator and 
Ombudsman in the review of a Center's denial of a request for section 
404 review is to ensure that all appropriate means of informally 
resolving the dispute have been used before review by the Deputy 
Commissioner. The Chief Mediator and Ombudsman will not make an 
independent determination of whether a section 404 review should be 
granted, but will work informally with the Center and the person denied 
section 404 review, to develop a mutually acceptable approach, taking 
into account all relevant factors.

II. Response to Comments

    FDA received five comments on the proposed rule; two from trade 
associations, one from a private company, one from a university medical 
clinic, and one from an FDA employee.
    1. One comment objected to FDA's conclusion that it was required to 
issue a regulation establishing a procedure for requesting review of 
scientific controversies only if procedures to request review of 
scientific controversies do not otherwise exist. According to the 
comment, section 404 of FDAMA requires FDA to establish a procedure to 
be used when there are no other specific provisions for requesting 
review of the particular type of scientific controversy at issue.
    FDA disagrees with this interpretation. Section 404 of FDAMA states 
``If *  *  * there is a scientific controversy *  *  * and no specific 
provision of the Act *  *  * including a regulation *  *  * provides a 
right of review of the matter in controversy, the Secretary shall, by 
regulation, establish a procedure *  *  *.'' The plain language of 
section 404 of FDAMA is that FDA must establish a procedure if 
scientific controversies could arise for which the act or regulations 
currently provide no right of review. In light of Sec. 10.75, which 
permits any interested person to obtain review of any FDA decision, FDA 
concludes that no additional procedure is required.
    However, as explained in the proposed rule, notwithstanding the 
existence of this universal dispute resolution provision, FDA 
recognizes that in appropriate circumstances, review by an advisory 
committee can provide the agency with useful insight and advice about 
the resolution of a scientific controversy. For this reason, FDA is 
amending Sec. 10.75 to indicate that sponsors, applicants, or 
manufacturers seeking review of scientific controversies are not 
limited to internal supervisory review, but may also request review by 
an advisory committee.
    2. One comment asserted that Congress' intent in enacting section 
404 of FDAMA was to provide a procedure for resolving disputes by 
expert committees who are not part of FDA's normal administrative 
processes. The comment also suggested that the procedure should solicit 
nominees from the public and FDA for inclusion on an advisory committee 
roster. According to the comment, the procedure should require prompt 
conflict of interest checks and periodic updates, in order to assure 
the timely disposition of controversies. In order to simplify the 
creation of a panel as much as possible, the comment suggested that the 
number of persons participating on each panel should be limited to 
three.
    FDA disagrees with this comment. The comment did not identify any 
specific language in section 404 of FDAMA suggesting that a procedure 
must be developed to use committees outside FDA's normal advisory 
committee processes. In fact, section 404 of FDAMA suggests the 
opposite, by its references to sections 505(n) and 515(g)(2)(B) of the 
act (21 U.S.C. 355(n) and 360e(g)(2)(B)), the statutory provisions 
covering FDA's existing drug and device advisory committees.
    As noted previously, FDA implementation of section 404 of FDAMA is 
Center-based. The Centers' existing advisory committee structures and 
processes for managing advisory committees provide significant 
flexibility. Each Center may tailor its current processes as necessary 
to ensure that section 404 reviews are conducted in a timely way by 
persons with appropriate qualifications.
    3. Two comments suggested specific timeframes for conducting 
section 404 reviews, and a third comment requested additional 
information about the timeframe for section 404 review. One suggested 
timeframe would require that a committee be constituted within 10 days 
of a written request for review, and the request be immediately 
forwarded to the committee. Also within 10 days of the request, FDA 
would be required to state its agreement with or opposition to the 
substantive points in the request, and forward its response to the

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committee. Within 20 days of the committee's receipt of FDA's response, 
a 21 CFR part 14 informal hearing would be convened, unless the parties 
agree to have the committee decide on the papers. If a hearing occurs, 
the committee would provide its written decision to the parties within 
20 days after the end of the hearing. If there is no hearing, the 
committee's decision would be required no later than 20 days after the 
committee receives FDA's response to the request for review.
    The second suggested timeframe would require FDA to respond to 
requests for section 404 review within 30 days. When review is granted, 
the issue would be presented to the committee within 60 days. FDA would 
be required to resolve the matter within 90 days of receiving the 
advisory committee's conclusions and recommendations.
    FDA recognizes that section 404 of FDAMA requires that reviews take 
place in a timely manner, but concludes that specific timeframes should 
not be included in a regulation of general applicability. For example, 
the second suggested timeframe outlined previously appears to be based 
on the timeframes established in section 120 of FDAMA and performance 
goals associated with the reauthorization of the Prescription Drug User 
Fee Act (21 U.S.C. 379g et seq.), both of which apply only to human 
drugs and biologics. It would be inappropriate to develop general 
timeframes based on requirements and commitments that do not apply to 
all affected FDA Centers. Each Center's section 404 processes 
incorporate timeframes as appropriate, taking into account applicable 
statutory and regulatory provisions, existing appeal and dispute 
resolution mechanisms, and approaches to advisory committee management.
    4. One comment suggested that representatives of the Office of the 
Chief Mediator and Ombudsman serve as executive secretaries of advisory 
committees convened to conduct section 404 reviews.
    FDA disagrees with this suggestion. The efficiency of the Center-
based approach to implementation of section 404 of FDAMA could be 
diminished by appointment of an executive secretary who is not an 
employee of the Center. Efficiency will be best promoted by using 
executive secretaries who are fully familiar with the advisory 
committee procedures. Center employees are most likely to have that 
expertise. The staff within the Office of the Chief Mediator and 
Ombudsman will continue to serve as an additional informal dispute 
resolution resource apart from the Centers.
    5. A comment suggested that the advisory committee's conclusions 
should be accepted as binding unless FDA determines that the weight of 
record evidence does not support the decision, that the committee 
applied incorrect legal standards or that the committee otherwise acted 
inconsistently with the law.
    FDA rejects this comment. Nothing in the language of section 404 of 
FDAMA, section 505(n) of the act, or section 515(g)(2)(B) of the act 
suggests that it would be appropriate to treat advisory committee 
recommendations as binding. Section 505(n) of the act contemplates 
convening advisory committees to provide ``expert scientific advice and 
recommendations *  *  *.'' When FDA receives a recommendation from an 
advisory committee convened under section 515(g)(2)(B) of the act, the 
agency is to affirm or reverse the order referred to the committee and 
state the reasons therefore. FDA accords the recommendations of all 
advisory committees significant weight, but believes it would be an 
unauthorized delegation of FDA authority to treat advisory committee 
recommendations as binding. FDA action on section 404 advisory 
committee recommendations is not final agency action subject to 
judicial review, unless otherwise required by law.
    6. A comment suggested that FDA must grant advisory committee 
review unless the committee itself declines to review the issue. 
Another comment seemed to assume that all requests for section 404 
reviews will be granted.
    FDA disagrees with these comments. The plain language of section 
404 of FDAMA provides sponsors, applicants, and manufacturers only the 
right to request review of a scientific controversy by an advisory 
committee. FDA believes that the agency, not a particular advisory 
committee, is in the best position to evaluate whether individual 
requests for section 404 review present appropriate issues to be raised 
before an advisory committee.
    Furthermore, although FDA endorses section 404's goal of 
facilitating the resolution of disputes by expanding access to the 
independent experts who serve on advisory committees, it concludes that 
Sec. 10.75 should include only those aspects of the process for 
obtaining section 404 reviews that are applicable to all affected 
Centers. Therefore, Sec. 10.75 includes a general mandate that requests 
for section 404 reviews shall not be unreasonably denied, and provides 
information about the process to be followed if requests are denied.
    To implement the rule's overall mandate that requests for section 
404 reviews shall not be unreasonably denied, the Center guidance 
documents provide information about granting or denying requests. 
Although Centers differ with respect to applicable laws, existing 
appeal and dispute resolution mechanisms, and approaches to advisory 
committee management, there are some situations in which all Centers 
would be likely to conclude that a section 404 review would not be 
appropriate. For example, the nature of the dispute may not be amenable 
to advisory committee review, the controversy might be more quickly and 
easily resolved in some other manner, or the issue may not be material 
to FDA's ultimate decision. Additionally, a section 404 review would be 
appropriate only if the matter relates to agency action on the 
requesting sponsor's own product. For example, a section 404 review 
would not be appropriate if it were requested for anti-competitive 
purposes, such as to prolong the review of a competitor's product. 
Furthermore, some issues are reviewed by advisory committees under 
regulatory processes that already provide for advisory committee 
review, and so section 404 review may be inappropriate given the 
preceding, or subsequent, regulatory processes.
    7. A comment suggested that the term ``scientific controversy'' be 
defined as ``one involving issues related to matters of technical 
expertise requiring some specialized education, training, or experience 
to understand and resolve.''
    FDA concludes that a definition of scientific controversy is not 
necessary in Sec. 10.75. The Center guidance documents may define a 
scientific controversy if the Centers conclude that a definition would 
be useful to its specific processes.
    8. A comment suggested that Sec. 10.75 outline the steps an 
applicant, sponsor, or manufacturer must take to request a section 404 
review. Another comment also requested information about how the review 
will take place and the general content and required number of copies 
of requests.
    FDA concludes that this information should not be included in 
Sec. 10.75. Under the Center-based approach FDA has selected to 
implement section 404 of FDAMA, each Center is providing information 
about the steps an applicant, sponsor, or manufacturer must take to 
request a section 404 review in guidance documents. The Centers' 
processes are tailored to take into account their applicable statutory

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and regulatory provisions, existing appeal and dispute resolution 
mechanisms, and approaches to advisory committee management. It would 
not be feasible to incorporate all these particulars in one regulation 
of general applicability.
    9. One of the comments interpreted the proposed amendment to 
Sec. 10.75 to require applicants, sponsors, and manufacturers to seek 
review through the supervisory chain before submitting a request for a 
section 404 review.
    FDA concludes that this issue is most appropriately addressed in 
Center-guidance documents rather than Sec. 10.75. The points at which 
it is appropriate to request a section 404 review will vary depending 
on the scientific issue presented, the regulatory mechanism involved, 
and the relevant Center's organizational structure. Both the applicant, 
sponsor, or manufacturer and the agency have an interest in resolving 
scientific controversies at the earliest appropriate time.
    10. Two comments suggested that persons other than sponsors, 
manufacturers, and applicants be given the right to request a review of 
a scientific controversy under section 404 of FDAMA. According to one 
comment, physicians, pharmacists, and/or their professional 
organizations should be permitted to request section 404 reviews. The 
comment identified compounding and unlabeled indications as potential 
sources of scientific controversy that might benefit from review under 
section 404 of FDAMA. The other comment requested that FDA employees be 
permitted to request review of disputes by advisory committees. 
According to this comment, advisory committee reviews would enable FDA 
to resolve issues with greater public input and on a more timely basis.
    FDA disagrees with the suggestions that persons other than 
sponsors, manufacturers, and applicants be given the right to request a 
review of a scientific controversy under section 404 of FDAMA. By 
limiting the right to request a section 404 review to sponsors, 
applicants, and manufacturers, Congress indicated the kind of 
scientific controversies it had in mind: Those arising within the 
context of FDA's regulation of a specific product. Thus, a section 404 
review would not be available to resolve broad public health 
controversies unrelated to the regulation of a specific product, or to 
resolve FDA's policy issues. The agency will continue to use 21 CFR 
part 15 hearings, public meetings, and advisory committee meetings to 
help resolve general scientific and policy issues.
    Moreover, FDA regulations provide persons other than sponsors, 
applicants, and manufacturers other processes for seeking review of FDA 
decisions. Citizen petitions may be submitted by any person. A citizen 
petition may request the Commissioner to issue, amend, or revoke any 
regulation or order, or to take or refrain from taking any other form 
of administrative action. (See 21 CFR 10.30.) Any person may request 
reconsideration of part or all of a decision made by the Commissioner 
in response to any type of administrative petition. (See 21 CFR 10.33 
and 10.25.) Finally, as noted in the proposed rule, any person may 
request review of any decision made by an FDA employee, other than the 
Commissioner, on any matter. (See Sec. 10.75.)
    11. Two comments expressed concern that FDA could retaliate against 
persons who request section 404 reviews, and for this reason suggested 
that persons be permitted to request section 404 reviews on behalf of 
sponsors, manufacturers and applicants, or that persons be permitted to 
request section 404 reviews anonymously.
    Although FDA takes concerns about retaliation very seriously, it 
disagrees with the comment because, as explained in the previous 
response, the comments' proposed changes have the potential to 
significantly change the kinds of controversies reviewed under section 
404.
    FDA reiterates and reaffirms its commitment to an environment in 
which challenges to agency decisions can be raised without fear of 
adverse consequences. By memo dated June 29, 1995, Commissioner Kessler 
reminded all FDA employees that companies are free to vigorously 
challenge agency positions and requirements, and to freely voice their 
views. By letter of the same date, Commissioner Kessler assured members 
of Congress that any act or threat of retaliation by any FDA employee 
is totally unacceptable and will not be tolerated. Anyone who believes 
retaliation has occurred, or is likely to occur, is urged to contact 
the Center Ombudsmen, Center Management, or the Office of the Chief 
Mediator and Ombudsman. If merited, specific allegations of retaliation 
will be forwarded to FDA's Office of Internal Affairs which 
investigates allegations of employee misconduct in cooperation with the 
Department's Inspector General's Office. FDA believes that its 
employees are highly sensitive to the need to avoid even the appearance 
of impropriety, and strive to make complex clinical, scientific, legal, 
and factual decisions fairly and even-handedly. Accordingly, FDA 
believes that sponsors, manufacturers, and applicants will not be 
dissuaded from requesting review of issues under section 404 of FDAMA.

III. Agency Guidance

    As explained previously, each FDA Center is providing detailed 
information in guidance documents about the implementation of section 
404 of FDAMA. For further information, see the FOR FURTHER INFORMATION 
CONTACT section of this document.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Pub. L. 104-121)) and the Unfunded Mandate Reform Act of 1995 
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The agency believes that this final rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the final rule is not a significant regulatory 
action as defined by the Executive Order and so is not subject to 
review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this rule does not impose any requirements 
on the regulated industry, the agency certifies that the final rule 
will not have a significant economic impact on a substantial number of 
small entities. Therefore, under the Regulatory Flexibility Act, no 
further analysis is required.

VI. Paperwork Reduction Act of 1995

    The final rule contains no new collections of information. 
Therefore,

[[Page 63982]]

clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 10

    Administrative practice and procedure, News media.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Public Health Service Act, and authority delegated to the Commissioner 
of Food and Drugs, 21 CFR part 10 is amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

    1. The authority citation for 21 CFR part 10 continues to read as 
follows:

    Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.

    2. Section 10.75 is amended by redesignating paragraph (b) as 
paragraph (b)(1) and by adding paragraph (b)(2) to read as follows:


Sec. 10.75  Internal agency review of decisions.

 * * * * *
    (b)(1) *  *  *
    (2) A sponsor, applicant, or manufacturer of a drug or device 
regulated under the act or the Public Health Service Act (42 U.S.C. 
262), may request review of a scientific controversy by an appropriate 
scientific advisory panel as described in section 505(n) of the act, or 
an advisory committee as described in section 515(g)(2)(B) of the act. 
The reason(s) for any denial of a request for such review shall be 
briefly set forth in writing to the requester. Persons who receive a 
Center denial of their request under this section may submit a request 
for review of the denial. The request should be sent to the Chief 
Mediator and Ombudsman.

    Dated: November 12, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-30812 Filed 11-17-98; 8:45 am]
BILLING CODE 4160-01-F