[Federal Register Volume 64, Number 229 (Tuesday, November 30, 1999)]
[Proposed Rules]
[Pages 66822-66828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. 99N-2497]


Citizen Petitions; Actions That Can be Requested by Petition; 
Denials, Withdrawals, and Referrals for Other Administrative Action

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations pertaining to citizen petitions. The proposal would 
cover citizen petition requests to issue, amend, or revoke a 
regulation; requests to amend or revoke an order that FDA has issued or 
published; or any other action specifically authorized by another FDA 
regulation. The document further clarifies that persons who wish to 
contact the agency on matters outside these three types of actions 
would still be able to do so through informal means, such as letters 
and telephone calls. In addition the proposal would also revise certain 
content requirements for citizen petitions and would permit FDA to 
refer petitions for other administrative action, seek clarification of 
a petitioner's requests, withdraw certain petitions, and combine 
petitions. These changes are intended to improve the citizen petition 
mechanism.

DATES: Submit written comments by February 28, 2000. Submit written 
comments on the information collection provisions by December 30, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit written comments on the information 
collection provisions to the Office of Information and Regulatory 
Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., Washington, 
DC 20503, ATTN: Wendy Taylor, Desk Officer for FDA

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3380.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    There are several mechanisms which can be used to contact FDA on a 
particular matter or issue. These mechanisms can be informal, such as 
calling the agency, sending a fax or electronic mail, writing a letter 
(see Sec. 10.65(a) (21 CFR 10.65(a))), or requesting a meeting (see, 
e.g., Sec. 10.65(b) and (c)). They may also be more formal, such as 
requesting a public hearing (see, e.g., 21 CFR 12.20) or submitting a 
citizen petition (see Sec. 10.30 (21 CFR 10.30)).
    Many persons use citizen petitions under Sec. 10.30 to contact FDA 
on a diverse range of issues. The issues can be very specific, such as 
detailed scientific concerns about a particular product's safety or 
bioequivalence, but occasionally pertain to matters outside FDA's 
jurisdiction or to matters that would require legislative, rather than 
regulatory, relief. This results in a large number of citizen petitions 
filed at FDA. As of April 1999, several hundred citizen petitions have 
been filed and remain pending.
    In many instances, it is readily apparent that citizen petitions 
may not be the best or most efficient mechanism for addressing the 
underlying subject or issue. For example, FDA often receives petitions 
requesting prompt or immediate action, yet each petition, after being 
filed and assigned to the appropriate office or center, must compete 
against other agency priorities, including other citizen petitions 
filed earlier. In contrast, a telephone call, letter, or a request for 
a meeting, while lacking the formal processing associated with citizen 
petitions, is usually an easier, faster, and more efficient way to 
discuss the same issue with the agency.
    Reviewing and responding to these petitions can also be, and often 
is, a resource-intensive and time-consuming task because FDA must 
research the petition's subject, examine scientific, medical, legal, 
and sometimes economic issues, and coordinate internal agency review 
and clearance of the petition response. In many instances, FDA must 
issue a tentative response stating that the agency is unable to reach a 
decision on the petition within the 180-day response period established 
in FDA's regulations.
    Questions have also arisen whether a citizen petition can be used 
for improper purposes, such as delaying competition (see, e.g., Noah, 
L., ``Sham Petitioning as a Threat to the Integrity of the Regulatory 
Process,'' 74 N. Carolina L. Rev. 1 (1995) (also noting that the 
Federal Trade Commission, in 1993, had concerns that petitions were 
being submitted to FDA for anticompetitive reasons)) or delaying agency 
action. Some petitioners have submitted multiple citizen petitions 
concerning the same subject or product

[[Page 66823]]

with each petition containing one or few requests, while others have 
submitted several citizen petitions on the same subject or product over 
an extended time period. These petitions drain FDA resources both 
repeatedly and inefficiently because they commit FDA to multiple 
reviews and responses rather than having FDA consider and respond to 
all issues at one time.
    Recently, the Office of the Inspector General (OIG) in the 
Department of Health and Human Services reviewed FDA's citizen 
petitions process to assess the agency's effectiveness in handling 
citizen petitions and to identify ways that the process can be 
improved. The OIG noted that FDA had examined various options for 
reducing the citizen petition backlog and suggested that those options 
be thoroughly discussed within the agency and ``implemented where 
practical.''
    This proposed rule contains several of those options and is 
intended to facilitate and to improve interactions between FDA and 
interested persons. The proposed rule would clarify the types of 
requests that may be the subject of a citizen petition and increase 
FDA's flexibility in responding to or taking action in response to a 
citizen petition.
    FDA emphasizes that the proposed rule is not intended to and does 
not reduce or curtail access to or discussions with the agency. For 
example, FDA's regulations provide for meetings and correspondence 
(see, e.g., Sec. 10.65), and other FDA regulations provide for meetings 
under certain situations (see, e.g., 21 CFR 314.102 (communication 
between FDA and persons who have submitted new drug application or 
abbreviated new drug application (ANDA))). Informal avenues of 
communication, such as telephone calls, faxes, and electronic mail, 
also exist. These avenues of communication can be faster and more 
efficient methods for discussing issues or addressing concerns than 
citizen petitions.
    In addition to this rule, FDA has taken, or is exploring, various 
administrative approaches to reduce its citizen petition backlog and 
improve its handling of citizen petitions. These actions have included 
contacting petitioners whose requests are of long standing to determine 
whether they still want FDA to take action on their petitions and 
revising delegations of authority so that certain FDA centers may issue 
a greater range of petition responses. FDA is also considering options 
for improving managerial and oversight responsibility for citizen 
petitions to ensure that the citizen petition process is efficient and 
effective.

II. Description of the Proposed Rule

    Under FDA's existing regulations, any person may submit a citizen 
petition to the agency requesting that the Commissioner of Food and 
Drugs (the Commissioner): (1) Issue, amend, or revoke a regulation; (2) 
issue, amend, or revoke an order; or (3) take or refrain from taking 
any other form of administrative action (Sec. 10.30(a) and (b)). The 
regulations also direct the agency to issue a response to a citizen 
petition within 180 days after receiving a petition (Sec. 10.30(e)(2)). 
(For petitions requesting permission to submit an ANDA for certain 
drugs, the response period is 90 days (see Sec. 10.30(e)(4)).) The 
response can either approve the petition, deny the petition, or provide 
a tentative response, indicating why the agency has been unable to 
reach a decision on the petition (Sec. 10.30(e)(2)).

A. Proposed Sec. 10.30(b)

1. Actions That May be Requested in a Citizen Petition
    The proposed rule would amend the citizen petition requirements at 
Sec. 10.30(b) and its description of the actions that may be requested 
in a citizen petition. Under the proposal, a citizen petition could 
request that the agency: (1) Issue, amend, or revoke a regulation; (2) 
amend or revoke an order that the agency has issued or published; or 
(3) take an action as specifically authorized by another FDA 
regulation.
    The proposal would not alter a person's ability to petition the 
agency for the issuance, amendment, or revocation of a regulation. The 
Administrative Procedure Act (5 U.S.C. 553(e)) expressly provides for 
such petitions, and the proposal would preserve a person's ability to 
petition for rulemaking.
    The proposal would, however, require that the requested regulation 
pertain to a subject that is appropriately and ordinarily addressed by 
regulation rather than other administrative action. For example, a 
petition that sought to amend the format and content requirements for 
an ANDA may be within the proposed rule because the requested change 
would be applicable to all ANDA's. However, a petition that sought a 
regulation directly or indirectly prohibiting the approval of a 
particular generic drug product, declaring a particular generic product 
to be unsafe, ineffective, or not bioequivalent, or prohibiting a class 
of generic drug products would, in most cases, not fall within the 
proposed rule because FDA generally does not issue regulations to 
prohibit the approval of individual generic drug products.
    FDA considered, but did not include in this proposed rule, a 
requirement that petitioners show why the requested rulemaking or 
action is within FDA's legal authority. The existing regulations 
require a petitioner to provide the factual and legal grounds on which 
the petitioner relies, but despite this requirement, the agency 
sometimes receives petitions requesting actions that are beyond FDA's 
legal authority or actions that are a matter of State law. For example, 
a petition requesting that FDA, under its existing statutory authority 
for drug products, regulate a particular class of drugs products would 
be appropriate, whereas a petition requesting that FDA require firms to 
observe certain employment practices (a matter that is generally not 
within FDA's legal authority) would not. Consequently, the agency 
contemplated various ways to have would-be petitioners request only 
those actions that fall under FDA's authority, but without requiring 
petitioners to provide a detailed or exhaustive legal analysis or to 
retain legal services to draft arguments on FDA's legal authority. The 
agency invites comments on how a rule might ask petitioners to ensure 
that their requested actions are within FDA's legal authority without 
making those petitioners do a detailed or exhaustive legal analysis.
    For citizen petitions concerning agency orders, the proposal would 
amend Sec. 10.30(b) to limit citizen petitions to requests that FDA 
amend or revoke an order that FDA has issued. In other words, a citizen 
petition could not be used to request that FDA amend pending FDA orders 
or issue future FDA orders. This change will enable FDA to focus its 
resources on addressing substantive issues or controversies, rather 
than devote resources to speculating about future orders or to 
addressing subjects which may not be an agency priority or present any 
significant public health issues.
     The proposal would also require the citizen petition to be based 
on more than unsupported claims, allegations, or general descriptions 
of positions or arguments. Although the existing regulation requires 
petitioners to provide a full statement of the factual grounds on which 
the petitioner relies, some petitions contain little or no evidence or 
support or rely on obsolete, irrelevant, or erroneous information. 
Thus, the proposal would deter the submission of frivolous or 
unsupported petitions and petitions which simply disagree with an 
agency decision regardless of the scientific evidence or legal 
authority supporting that decision, the importance of the public health

[[Page 66824]]

policies supporting that decision, or the petitioner's lack of sound 
scientific evidence or legal authority to support its request.
    FDA is aware that the proposed change would remove a person's 
ability to petition FDA to issue an order or to affect a pending order 
and that some may object to this proposed change on the ground that 
persons should be able to present arguments and evidence to FDA before 
it makes a decision. Again, the agency emphasizes that the proposal 
does not prevent a person from contacting FDA nor does it curtail 
access to the agency. Persons who desire to present information to FDA 
would be able to do so through letters, electronic mail, meetings, 
discussions, and other avenues of communication. If FDA receives 
important information before it makes a decision, it will make 
appropriate use of that information. For example, if a person submitted 
information to FDA to argue that a particular test should be conducted 
before FDA approves a specific product, the agency may consider that 
information during its review of the product's application and consult 
the applicant and others on the issue. The fact that the information 
may not have been submitted in a citizen petition does not make the 
information any less persuasive or mean that it will receive less 
attention from FDA. In short, the citizen petition mechanism is not the 
sole mechanism for contacting FDA, especially with respect to persons 
who wish to provide information to FDA before the agency decides on or 
takes a specific course of action.
    The proposal would also change the third category of citizen 
petitions -- petitions requesting that the Commissioner ``take or 
refrain from taking any other form of administrative action''-to 
petitions requesting that the Commissioner take an action ``as 
specifically provided by regulation'' and would require the petitioner 
to cite the regulation at issue. The reference to actions 
``specifically provided by regulation'' is intended to reflect over 20 
FDA regulations which expressly provide for or instruct interested 
persons to submit citizen petitions in order to achieve a particular 
result. For example, under 21 CFR 60.30(b), a person may file a citizen 
petition if that person wishes to challenge the regulatory review 
period determination for a particular product which is being considered 
for patent term extension. FDA's regulations permit persons to submit a 
citizen petition if they seek an exemption from the pregnancy nursing 
warning (21 CFR 201.63(d)). Under 21 CFR 861.38(b)(2), an interested 
person may petition to establish, amend, or revoke a performance 
standard. The proposed rule would continue to allow petitions under 
these and other FDA regulations that expressly refer to the citizen 
petitions process, but the proposal would no longer provide an 
unqualified ability to use the citizen petition process for ``any other 
form of administrative action.''
    FDA reiterates that persons who wish to contact FDA on matters 
outside the three types of actions described in proposed Sec. 10.30(b) 
would still be able to do so through other means, such as 
correspondence, electronic mail, telephone calls, etc., and FDA will 
respond to such correspondence and other communications promptly. The 
agency is simply reorganizing its citizen petition mechanism to make it 
more focused and responsive.
2. Certification Statement for Citizen Petitions 
    Currently, Sec. 10.30(b) requires a petitioner to certify, to its 
best knowledge and belief, that the petition includes all information 
and views on which the petitioner relies and includes ``representative 
data and information known to the petitioner which are unfavorable to 
the petition.'' To complement the other proposed changes to 
Sec. 10.30(b), FDA is proposing to revise the certification statement. 
The proposed revision would have petitioners certify that, to the 
petitioner's best knowledge and belief, its citizen petition ``includes 
all information and views on which the petition relies, that it is well 
grounded in fact and is warranted by existing laws or regulations, that 
it is not submitted for any improper purpose, such as to harass or to 
cause unnecessary delay, and that it includes representative data and 
information known to the petitioner which are unfavorable to the 
petition.''

B. Proposed Sec. 10.30(e)(2)(ii)--Denial of Citizen Petitions

    To facilitate responses to citizen petitions and to promote more 
efficient use of agency resources, the proposed rule would amend 
Sec. 10.30(e)(2)(ii) to state that FDA's denial of a citizen petition 
may be ``brief, as appropriate.'' This is intended to conserve FDA's 
resources by eliminating the need to conduct exhaustive or 
comprehensive analyses and responses to requests or issues that the 
agency has already decided earlier in a different administrative 
proceeding or action and to give FDA the flexibility to act quickly on 
petitions where detailed responses are unnecessary. For example, under 
the proposal, if the citizen petition asked the agency to amend a 
regulation in a particular way, and FDA considered and rejected the 
same comment or a similar comment when the agency was drafting the 
final regulation, and the citizen petition contained no new evidence 
warranting a change in FDA's earlier decision, the agency's denial 
letter might simply state that the agency considered the same matter 
during the rulemaking and that the petition did not provide any new 
information that would change FDA's earlier decision.
     Other examples of where a brief response denying a petitioner's 
request may be appropriate include, but are not limited to:
    1. A citizen petition that makes a request that is outside FDA's 
legal authority or is based on unsupported claims or allegations. This 
would complement the changes in proposed Sec. 10.30(b).
    2. A citizen petition that is substantially similar or identical, 
in terms of its requests or issues, to an earlier administrative 
proceeding or action, and the citizen petition has not identified any 
significant change in evidence, laws, or regulations that affect the 
previous administrative proceeding or action. For example, in the past, 
some petitioners have submitted the same or similar petitions after 
receiving an unfavorable response. In these situations, when there has 
been no change in evidence, laws, or regulations since FDA's earlier 
response, the agency's denial letter might simply say that the agency 
has previously considered the same or similar request and that the 
petition has provided no new information that would change the agency's 
earlier decision.
    3. A citizen petition where the agency has determined that the 
petition does not implicate a significant public health issue, and the 
agency lacks the resources to provide a more detailed response or to 
take the action requested by the petitioner. This may occur, for 
example, where the petitioner requests a change in FDA's regulations 
that has no significant public health implications, such as amending or 
establishing common or usual names regulations or standards of 
identity, quantity, and fill of container regulations for foods or 
allowing the use of a different test or method or a different 
manufacturing standard when the difference has no significant public 
health advantage over the existing test, method, or standard. In the 
absence of a significant public health issue, and considering the 
intense demand on FDA's resources, the agency must allocate its 
resources carefully and

[[Page 66825]]

wisely, so brief denial of these types of citizen petitions would be 
appropriate.
    4. A citizen petition where changes in fact, science, or law since 
the date on which the citizen petition was submitted have made the 
petition moot. For example, if a citizen petition requested a change to 
a regulation that has been rescinded or withdrawn, drafting a detailed 
response to the petitioner's requested change would not be an efficient 
use of agency resources. Thus, a brief denial for these petitions would 
be appropriate.

C. Proposed Sec. 10.30(e)(4)--Referral and Withdrawal of Citizen 
Petitions and Consolidation of Multiple Petitions

    Proposed Sec. 10.30(e)(4)(i) would authorize FDA to take 
administrative action other than preparing a formal response to a 
citizen petition. This would occur when a citizen petition involves a 
subject that is being addressed in another administrative proceeding 
(such as an ongoing or future rulemaking) or presents issues or 
involves requests that can be addressed through correspondence, 
meetings, or other agency action. Under such circumstances, the 
proposed rule would permit, but not require, the agency to refer the 
petitioner's information to the other administrative proceeding or to 
refer the petitioner's information to the relevant FDA center for its 
consideration and any appropriate action. If FDA refers a citizen 
petition to another administrative proceeding, the citizen petition 
would remain filed in FDA's Dockets Management Branch, but the agency 
would place a note in the citizen petition's docket stating that the 
petitioner's information has been referred to another administrative 
proceeding and that the petition's docket is closed.
    For example, FDA sometimes receives petitions on topics that are 
the subject of a pending FDA regulation. Under the proposed rule, FDA 
could refer the petition to the docket for the rulemaking where it 
would be treated as if it were a comment on the rule, and the 
petition's docket would contain a note referring to the rulemaking. 
Referring information to the appropriate administrative proceeding 
would be an efficient and practical mechanism for reviewing scientific 
or technical issues because it would ensure that the relevant FDA 
office considers the petitioner's information in conjunction with the 
data and information contained in the administrative proceeding (as 
opposed to allocating separate resources to the administrative 
proceeding and to the citizen petition or completing the administrative 
proceeding and citizen petition at different times).
    As another example, some petitions raise substantive scientific 
issues and request that the agency not approve or rescind approval of a 
specific product. In these cases, it may be more appropriate for the 
agency to investigate the scientific issues or conduct a meeting to 
discuss those issues before deciding what regulatory action, if any, to 
take against the product. Thus, the proposed rule would preserve FDA's 
flexibility to develop the appropriate administrative response. This 
flexibility may be particularly valuable when, after reviewing the 
petitioner's request, the agency determines that the best solution is 
different from the one suggested by the petitioner.
    Proposed Sec. 10.30(e)(4)(ii) would permit the agency to seek 
clarification of a petitioner's requests. Occasionally, FDA receives 
citizen petitions that make vague or conflicting requests, but the 
existing regulations do not expressly permit FDA to request 
clarification from the petitioner. The proposal would remedy this by 
permitting FDA to seek clarification. The request for clarification 
would include a time period for providing the clarifying information to 
FDA. If the petitioner fails to provide the requested clarification to 
FDA within that time period, proposed Sec. 10.30(e)(4)(ii) would permit 
the agency to consider the petition to be withdrawn.
    Proposed Sec. 10.30(e)(4)(iii) would permit FDA to consider a 
citizen petition to be withdrawn where the agency is aware that the 
petitioner no longer exists or the petitioner cannot be located, or 
where the petitioner has expressly stated that it does not seek a 
response to its petition. For example, if a firm submitted a citizen 
petition and subsequently went out of business, the proposal would 
permit FDA to consider the petition to be withdrawn. As another 
example, in rare cases, persons have submitted citizen petitions to 
protest a particular FDA action. These petitions state that they are 
submitted as a protest or for symbolic reasons and that no response is 
sought or expected. Nevertheless, existing regulations do not give FDA 
express authority to withdraw these petitions even though it is both 
illogical and a waste of agency resources to require FDA to develop and 
to issue petition responses when the petitioner no longer exists or 
when the petitioner seeks no response. The agency does not contemplate 
using this authority often.
    Proposed Sec. 10.30(e)(4)(iv) would apply where FDA has received 
multiple citizen petitions on the same subject or involving the same 
product or has received similar or identical citizen petitions from 
different parties. These citizen petitions, which sometimes contain 
only a single request and are submitted over an extended period of 
time, divert FDA resources repeatedly and, from FDA's perspective, 
inefficiently when the petitioner or petitioners could have easily 
submitted all requests in the same petition or when the petitioner 
submits essentially the same petition repeatedly. The proposal, 
therefore, would enable FDA to combine multiple citizen petitions on 
the same issue or product. The agency encourages potential petitioners 
to combine petitions and requests to the greatest extent practicable.

D. Conforming or Miscellaneous Amendments

    Section 10.25(a) (21 CFR 10.25(a)) currently states how petitions 
can be used to initiate an administrative proceeding. Because proposed 
Sec. 10.30 would redefine the types of actions that may be the subject 
of a citizen petition, the agency is proposing to revise Sec. 10.25(a) 
to enable interested persons to request (rather than ``petition'' for) 
the initiation of an administrative proceeding. Such requests would be 
made when the desired administrative proceeding falls outside the scope 
of proposed Sec. 10.30.
    Because the proposed rule would permit the agency to refer and to 
withdraw citizen petitions under certain conditions, two conforming 
amendments to Sec. 10.30(e)(1) and (e)(2) would be necessary. 
Currently, Sec. 10.30(e)(1) states that the Commissioner shall ``rule 
upon'' each petition. Arguably, because a decision to withdraw a 
citizen petition does not necessarily involve a decision directly on 
the citizen petition's merits, FDA is proposing to amend 
Sec. 10.30(e)(1) to state that the Commissioner shall ``act upon'' each 
citizen petition.
    Similarly, Sec. 10.30(e)(2) states that the Commissioner shall 
furnish a response to each petitioner within 180 days (except to 
persons who submitted suitability petitions, in which case the response 
time period is 90 days). Arguably, a decision to refer or withdraw a 
citizen petition under the proposed rule might not be considered a 
``response,'' so FDA is proposing to amend Sec. 10.30(e)(2) to state 
that, ``Except as provided in paragraphs (e)(4) and (e)(5) of this 
section * * *.''
    The proposal would also revise Sec. 10.30(b) to update the address 
for the Dockets Management Branch.

[[Page 66826]]

III. Legal Authority

     When first issued over 20 years ago, FDA's citizen petition 
regulations were intended to reflect the right to petition the 
government and to reduce ``confusion and uncertainty on the part of 
those who wish to petition the agency on a particular matter, as well 
as on the part of those in the agency who have received various forms 
of requests and have been unable to determine how they should be 
handled'' (see 40 FR 40682 at 40686, September 3, 1975).
    The right to petition, however, is not absolute; it does not 
include the right to speak to government officials (see Welch v. Board 
of Education of Baltimore County, 477 F. Supp. 959 (D. Md. 1979)), nor 
does it include the right to an oral hearing (see Stengel v. City of 
Columbus, Ohio, 737 F. Supp. 1457 (S.D. Ohio 1988)). Neither does the 
right to petition the government create an affirmative duty on the 
government to act or to investigate. See Minnesota State Board for 
Community Colleges v. Knight, 104 S. Ct. 1058, 1067 (1984); Smith v. 
Arkansas State Highway Employees, 441 U.S. 463, 465 (1979); Gordon v. 
Heimann, 514 F. Supp. 659 (N.D. Ga. 1980); Town of Brookline v. 
Goldstein, 447 N.E.2d 641, 646 (Mass. 1983).
    In fact, court opinions indicate that agencies have broad 
discretion in establishing and applying rules for public participation 
in agency matters (see Cities of Statesville, et al. v. Atomic Energy 
Commission, 441 F. 2d 962 (D.C. Cir. 1969); Pasco Terminals, Inc. v. 
United States, 477 F. Supp. 201 (1979), aff'd 634 F. 2d 610)). 
Moreover, the Supreme Court has indicated that courts cannot require 
more than minimum procedural boundaries even if a proposed regulation 
would establish complex or technical factual issues or important public 
issues; in those instances, an agency is to decide whether additional 
procedures are needed. See Vermont Yankee Nuclear Power Corp. v. 
Natural Resources Defense Council, Inc., 98 S. Ct. 1197, 1202 (1978).
    Here, the proposed rule does not restrict access to or contact with 
the agency; it simply redefines the types of actions that may be the 
subject of ``citizen petitions'' under Sec. 10.30 in order to make that 
formal administrative mechanism more responsive and efficient. Indeed, 
given that other FDA's regulations provide other means for contacting 
the agency (see, e.g., Sec. 10.65(a) (regarding correspondence)), the 
citizen petition regulation at Sec. 10.30 cannot and should not be 
viewed as being the sole or exclusive mechanism for ``petitioning'' FDA 
or as an exclusive mechanism for exercising a right to petition FDA.
    Certain aspects of the proposed rule, such as the proposed 
provisions concerning brief denials, withdrawals, and referrals to 
other administrative action, would affect how citizen petitions are 
handled. However, as stated earlier, agencies have broad discretion in 
establishing and applying rules for public participation in 
administrative matters. The proposal furthers an important government 
interest-permitting the agency to concentrate its resources on agency 
priorities and statutory obligations instead of diverting those 
resources to, for example, citizen petitions that request actions 
outside FDA's authority, that repeat requests that the agency has 
already addressed, or that are submitted for symbolic purposes.
     Furthermore, as court decisions readily indicate, the right to 
petition does not impose any duty on the government to take any 
specific action. Given this case precedent, it would be illogical to 
conclude that the right to petition demands that FDA continue to 
receive citizen petitions under Sec. 10.30 requesting actions which FDA 
cannot legally perform or to have FDA decide how it might act on a 
particular issue in the future. The proposed rule preserves an 
individual's ability to submit a citizen petition to FDA for actions 
that FDA has taken and for actions that are within FDA's legal 
authority, as well as other types of actions specified in proposed 
Sec. 10.30.
    Persons who wish to contact or ``petition'' FDA on issues that are 
outside the scope of proposed Sec. 10.30 would still be able to contact 
the agency, through letters, calls, or other means of communication. 
FDA emphasizes, again, that the proposed rule would not reduce public 
access to FDA; instead, it is intended to make the formal citizen 
petition process more efficient and more responsive.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(a) and (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 this proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) and 
the Unfunded Mandates Reform Act of 1995 (Public Law 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 new benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Under the Regulatory 
Flexibility Act, unless an agency certifies that a rule will not have a 
significant impact on a substantial number of small entities, the 
agency must analyze regulatory options that would minimize the impact 
of the rule on small entities.
    The Unfunded Mandates Reform Act of 1995 requires that agencies 
prepare an assessment of anticipated costs and benefits before 
proposing any rule that may result in an expenditure in any one year by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation).
    The agency has reviewed this proposed rule and determined that it 
is consistent with the regulatory philosophy and the principles 
identified in the Executive Order 12866 and these two statutes. Though 
this proposed rule is not economically significant, it has been 
determined by OMB that this proposed rule is a significant regulatory 
action.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant economic impact 
on small entities. The proposed rule would define the actions that may 
be the subject of a citizen petition and facilitate efficient 
resolution of citizen petitions. It would not preclude persons from 
using less formal means (such as letters) to contact the agency. In 
fact, because less formal means of communication lack the format and 
procedures associated with citizen petitions, the economic impact on 
small businesses should be reduced when compared against the existing 
citizen petition mechanism. Thus, the agency certifies that this 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

    This rule contains information collection requirements that are 
subject to public comment and review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). A description of these provisions is given

[[Page 66827]]

below in this section of the document with an estimate of the annual 
reporting and recordkeeping burden. Included in the estimate is the 
time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    FDA invites comments on: (1) Whether the 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 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.
    Title: Citizen Petitions; Actions That Can be Requested by 
Petition; Denials, Withdrawals, and Referrals for Other Administrative 
Action
    Description: The proposed rule would specify the types of actions 
that could be requested through a citizen petition. The proposal would 
also revise the content requirements for citizen petitions and provide 
authority for the agency to refer petitions for other administrative 
action, seek clarification of a petitioner's requests, withdraw certain 
petitions, and combine petitions.
    Description of Respondents: Businesses, trade organizations, public 
interest groups, and individuals.
    The proposed rule would increase the estimated burden associated 
with the information collection requirements from 1,440 hours to 2,646 
hours. FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
10.30                                 189               1             189              14           2,646
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimates in Table 1 reflect the reporting burden that would be 
attributable solely to the rule. FDA derived these estimates by 
examining its records to determine the average number of citizen 
petitions submitted to FDA and by decreasing the number of respondents 
by 30 percent. The agency calculated the percentage reduction in 
citizen petitions by reviewing all citizen petitions filed in a 6-month 
period in 1997 against the proposed rule's citizen petition criteria. 
The review suggested that the proposed rule would reduce the number of 
citizen petitions by over 30 percent, but the agency is adopting the 30 
percent estimate as an initial estimate.
    Additionally, FDA has revised the hours per response from 12 hours 
to 14 hours. The additional two hours reflect the proposed rule's 
changes to the content requirements for a citizen petition and the 
change to the certification statement. This additional amount of time 
may be overestimated because, under the existing citizen petition 
regulation, petitioners are already required to provide all relevant 
information and views and a certification as part of their petitions.
    The agency has submitted the information collection requirements of 
this rule to OMB for review. Interested persons are requested to send 
comments regarding information collection by December 30, 1999, to the 
Office of Information and Regulatory Affairs, OMB (address above).
    Interested persons may, on or before February 28, 2000, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 10

    Administrative practice and procedure, News media.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 10 be 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, 236b, 264.
    2. Section 10.25 is amended by revising paragraph (a) to read as 
follows:

Sec. 10.25  Initiation of administrative proceedings.

* * * * *
    (a) An interested person may petition the Commissioner to issue, 
amend, or revoke a regulation or order, or request that the 
Commissioner take or refrain from taking any other form of 
administrative action. For petitions involving a regulation or order, 
the petition must be either:
     (1) In the form specified in other applicable FDA regulations, 
e.g., the form for a color additive petition in Sec. 71.1 of this 
chapter, for a food additive petition in Sec. 171.1 of this chapter, 
for a new drug application in Sec. 314.50 of this chapter, for a new 
animal drug application in Sec. 514.1 of this chapter, or
     (2) In the form for a citizen petition in Sec. 10.30. For requests 
involving administrative action, the request may be made in any written 
form (e.g., letter, facsimile).
 * * * * *
     3. Section 10.30 is amended by revising paragraphs (b), (e)(1), 
the introductory text of paragraph (e)(2), paragraph (e)(2)(ii), by 
redesignating paragraph (e)(4) as (e)(5), and by adding a new paragraph 
(e)(4) to read as follows:


Sec. 10.30  Citizen petition.

* * * * *
    (b) A petition (including attachments) shall be submitted in 
accordance with Sec. 10.20 and in the following form:
    (Date) __________________________________
     Dockets Management Branch (HFA-305), Food and Drug 
Administration, Department of Health and Human Services, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

                                    CITIZEN PETITION

    The undersigned submits this petition under ____ (relevant 
statutory sections, if known) of the ____ (Federal Food, Drug, and 
Cosmetic Act or the Public Health Service Act or any other statutory 
provision for which authority has been delegated to the

[[Page 66828]]

Commissioner of Food and Drugs under 21 CFR 5.10) to request that 
the Commissioner of Food and Drugs ____ (issue, amend, or revoke a 
regulation or amend or revoke an order that the agency has issued or 
published or take an action as specifically provided by regulation).

A. Action requested

    ((1) If the petition requests that the Commissioner issue, 
amend, or revoke a regulation, the exact wording of the existing 
regulation (if any) and the proposed regulation or amendment 
requested.)
    ((2) If the petition requests that the Commissioner amend or 
revoke an order, the date on which the order was issued or 
published, the exact wording and the citation for the existing order 
and, if the request is to amend an order, the exact wording 
requested for the amended order.)
    ((3) If the petition requests that the Commissioner take an 
action, and a petition is specifically required by regulation, a 
citation of the regulation and the specific action requested.)

B. Statement of grounds

    (A full statement, in a well organized format, of the factual 
and legal grounds on which the petitioner relies, including all 
relevant information and views on which the petitioner relies, as 
well as representative information known to the petitioner which is 
unfavorable to the petitioner's position. Additionally, for 
petitions requesting that FDA issue, amend, or revoke a regulation, 
the petition shall show why the requested regulation pertains to a 
subject that is appropriately addressed by regulation rather than 
other administrative action. For petitions requesting that FDA amend 
or revoke an order that was issued or published, the petition shall 
be based on more than unsupported claims, allegations, or general 
descriptions of positions or arguments.

C. Environmental impact

    (A claim for categorical exclusion under Secs. 25.30, 25.31, 
25.32, 25.33, or Sec. 25.34 of this chapter or an environmental 
assessment under Sec. 25.40 of this chapter.)

D. Economic impact

    (The following information is to be submitted only when 
requested by the Commissioner following review of the petition: A 
statement of the effect of the requested action on: (1) Cost (and 
price) increases to industry, government, and consumers; (2) 
productivity of wage earners, businesses, or government; (3) 
competition; (4) supplies of important materials, products, or 
services; (5) employment; and (6) energy supply or demand.)

E. Certification

    The undersigned certifies, that, to the best knowledge and 
belief of the undersigned, this petition includes all information 
and views on which the petition relies, that it is well grounded in 
fact and is warranted by existing laws or regulations, that it is 
not submitted for any improper purpose, such as to harass or to 
cause unnecessary delay, and that it includes representative data 
and information known to the petitioner which are unfavorable to the 
petition.
    (Signature) __________________________
    (Name of petitioner) __________________
    (Mailing address) ____________________
    (Telephone number)__________________
* * * * *
    (e)(1) The Commissioner shall, in accordance with paragraph (e)(2) 
of this section, act upon each petition filed under paragraph (c) of 
this section, taking into consideration:
    (i) Available agency resources for the category of subject matter;
    (ii) The priority assigned to the petition considering both the 
category of subject matter involved and the overall work of the agency; 
and
    (iii) Time requirements established by statute.
    (2) Except as provided in paragraphs (e)(4) and (e)(5) of this 
section, the Commissioner shall furnish a response to each petitioner 
within 180 days of receipt of the petition. The response will either:
* * * * *
    (ii) Deny the petition; the denial may be brief, as appropriate; or
* * * * *
     (4) The Commissioner may:
     (i) Refer a petition for other administrative action instead of 
issuing a response. In such cases, the agency shall place a note in the 
docket for the petition stating that the petition has been referred for 
other administrative action and close the docket for the petition. FDA 
may refer a petition for other administrative action if the petition:
    (A) Involves issues that are the subject of an ongoing or future 
administrative proceeding. In such cases, the agency may consider the 
issues raised by the petition as part of the administrative record for 
the administrative proceeding;
    (B) Presents scientific or technical issues or data that are 
specific to a particular product or class of products;
     (C) Requests a regulation on an issue that is not appropriately 
addressed by regulation;
     (D) Does not involve a significant public health or consumer 
protection issue; or
     (E) Involves a subject that is appropriately addressed by other 
administrative action.
     (F) For petitions described in paragraphs (e)(4)(i)(B) through 
(e)(4)(i)(E) of this section, the agency may treat the petition as 
correspondence under Sec. 10.65.
     (ii) Request clarification if the petition presents vague or 
conflicting requests. If the petitioner does not respond to the request 
for clarification within a time specified by FDA, the petition may be 
considered withdrawn;
     (iii) Consider the petition to be withdrawn if the petitioner no 
longer exists or cannot be located or the petitioner has stated that it 
does not seek a response from the agency; or
    (iv) Combine petitions and supplements submitted by the same 
petitioner or by different petitioners if those petitions concern the 
same or similar subjects or products.
 * * * * *

    Dated: August 10, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-30957 Filed 11-29-99; 8:45 am]
BILLING CODE 4160-01-F