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

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