Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets, 25-34 [2011-33622]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 77, Number 1 (Tuesday, January 3, 2012)]
[Proposed Rules]
[Pages 25-34]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. FDA-2011-N-0697]


Amendments to Regulations on Citizen Petitions, Petitions for 
Stay of Action, and Submission of Documents to Dockets

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
certain regulations relating to citizen petitions, petitions for stay 
of action, and the submission of documents to the Agency. In 
particular, the proposed rule would establish new regulations to 
implement certain provisions of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act), which concern certain citizen petitions and petitions 
for stay of action (PSAs) that involve a request for FDA to take any 
form of action relating to a pending abbreviated new drug application 
(ANDA) or 505(b)(2) application. We are making these changes to 
implement provisions of the Food and Drug Administration Amendments Act 
of 2007 (FDAAA).

DATES: Submit either electronic or written comments by April 2, 2012. 
Submit comments on information collection issues under the Paperwork 
Reduction Act of 1995 by February 2, 2012, (see section ``VI. Paperwork 
Reduction Act of 1995'' of this document). See section II.E of this 
document for the proposed effective date of a final rule based on this 
proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0697, by any of the following methods; except that comments on 
information collection issues under the Paperwork Reduction Act of 1995 
must be submitted to the Office of Regulatory Affairs, Office of 
Management and Budget (OMB) (see the ``Paperwork Reduction Act of 
1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX: (301) 827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2011-N-0697 for this rulemaking. All comments 
received may be posted without change to https://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: 
    Nicole Mueller, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6312, 
Silver Spring, MD 20993-0002, (301) 796-3601.

SUPPLEMENTARY INFORMATION:

I. Background

A. Enactment of Section 505(q)

    On September 27, 2007, Congress enacted FDAAA (Pub. L. 110-85). 
Section 914 of title IX of FDAAA added new section 505(q) to the FD&C 
Act (21 U.S.C. 355(q)). Section 505(q) applies to certain citizen 
petitions and PSAs (collectively referred to as petitions) that request 
FDA to take any form of action related to a pending application 
submitted under section 505(b)(2) or (j) of the FD&C Act (21 U.S.C. 
355(b)(2) or (j)). An application submitted under section 505(b)(2) of 
the FD&C Act is a type of new drug application (NDA) described in that 
subsection and is referred to in this document as a ``505(b)(2) 
application.'' An application submitted under section 505(j) is an ANDA 
for a generic drug product.
    Section 505(q) governs the manner in which FDA handles certain 
citizen petitions and PSAs that ask the Agency to take any form of 
action related to pending 505(b)(2) applications or ANDAs. Over the 
years, FDA has received numerous petitions asking the Agency not to 
approve a particular ANDA or 505(b)(2) application (or classes of these 
applications concerning a particular drug product or active ingredient) 
unless certain criteria set forth in the petition are met. In many 
cases, the petitions have raised scientific and/or legal issues 
relating to the standards for approval of an application. Examples 
include: Petitions suggesting a particular method for determining the 
bioequivalence of a proposed generic product to the reference listed 
drug (RLD) and petitions maintaining that a proposed generic product 
does not contain the same active ingredient as the RLD. When submitted 
early, such as when we are making decisions about the bioequivalence 
requirements for a generic drug product or before we have received the 
first ANDA or 505(b)(2) application for a drug product, a petition 
containing material information can assist us in establishing standards 
for these applications. However, when petitions are submitted late in 
the review process for challenged applications and do not raise valid 
scientific and/or legal issues, they may have the effect of improperly 
delaying the approval of an application. By enacting section 505(q), 
Congress indicated a desire to ensure that petitions not be used to 
improperly delay approval of ANDAs and 505(b)(2) applications.

B. Provisions of Section 505(q) of the FD&C Act

    Section 505(q)(1)(A) of the FD&C Act specifies that FDA must not 
delay approval of a pending ANDA or 505(b)(2) application because of 
any request to take any form of action relating to the application, 
unless the request is in writing and in a citizen petition submitted 
under Sec.  10.30 (21 CFR 10.30) or a PSA submitted under Sec.  10.35 
(21 CFR 10.35), and the Agency determines, upon reviewing the petition, 
that a delay is necessary to protect the public health.
    Section 505(q)(1)(F) of the FD&C Act governs the timeframe for 
final Agency action on a petition. Under this provision, FDA must take 
final Agency action on a petition not later than 180 days after the 
date on which the petition

[[Page 26]]

is submitted. The 180-day period is not to be extended for any reason 
including any determination made under section 505(q)(1)(A) regarding 
delay of approval of an application (i.e., that delay is necessary to 
protect the public health), the submission of comments or supplemental 
information, or the consent of the petitioner. In addition, FDA may 
deny a petition at any point if it determines that a petition or a 
supplement to the petition was submitted with the primary purpose of 
delaying the approval of an application and the petition does not on 
its face raise valid scientific or regulatory issues (section 
505(q)(1)(E) of the FD&C Act). FDA may issue guidance to describe the 
factors that will be used to determine whether a petition is submitted 
with the primary purpose of delaying the approval of an application 
(section 505(q)(1)(E) of the FD&C Act).
    Section 505(q) of the FD&C Act also includes certification and 
verification requirements for certain documents. Under section 
505(q)(1)(H) of the FD&C Act, FDA may not consider a petition for 
review unless the petition is in writing and signed and contains a 
certification that is specified in that section. In addition, we may 
not accept for review any supplemental information or comments on a 
petition unless the submission is in writing and signed and contains a 
specific verification (section 505(q)(1)(I) of the FD&C Act).

II. Description of the Proposed Rule

    FDA is proposing to amend our regulations on general administrative 
procedures in part 10 (21 CFR part 10) to implement section 505(q) of 
the FD&C Act. We are proposing to add new Sec.  10.31, which includes 
the following provisions:
     Proposed Sec.  10.31(a) states that Sec.  10.31 would 
encompass all citizen petitions and PSAs that request that the Agency 
take any action that could, if taken, delay approval of an ANDA or 
505(b)(2) application (i.e., petitions and PSAs that are or may be 
subject to section 505(q) of the FD&C Act).
     Proposed Sec.  10.31(b) would clarify the date of 
submission for petitions submitted under Sec.  10.31.
     Proposed Sec.  10.31(c) and (d) would codify the 
certification and verification requirements of section 505(q)(1)(H) and 
(I). Although the certification and verification requirements of 
section 505(q)(1)(H) and (I) include that the document be signed, we 
have not proposed a regulation that explicitly states that submissions 
under Sec.  10.31 or Sec.  10.35 must be signed because current Sec.  
10.20 requires that all submissions made to the Division of Dockets 
Management be signed.
    We are also proposing minor revisions to Sec. Sec.  10.20 and 10.30 
to conform with the addition of proposed Sec.  10.31.
    With respect to Sec.  10.35, administrative stay of action, we are 
proposing a revision to conform with the implementation of section 
505(q). We are also proposing to add new Sec.  10.35(i) to clarify that 
a petitioner for a stay of action may supplement, amend, or withdraw a 
PSA, similar to the provision for citizen petitions in current Sec.  
10.30(g).
    In addition to implementing the provisions in section 505(q) of the 
FD&C Act, we are proposing minor technical changes to revise Sec. Sec.  
10.30(e)(3) and 10.35(e) to allow the Commissioner of Food and Drugs 
(the Commissioner) to dismiss petitions as moot.

A. Submission Date for a Citizen Petition Submitted Under Section 
505(q) of the FD&C Act

    Proposed Sec.  10.31(b) would make clear that for a petition that 
could be subject to section 505(q) of the FD&C Act and submitted under 
proposed Sec.  10.31, the date of submission is the date on which the 
petition is received by the Division of Dockets Management. Proposed 
Sec.  10.31(b) also states that the petition must be submitted in 
accordance with Sec. Sec.  10.20, 10.30, 10.31, and 10.35, the other 
relevant regulations regarding citizen petitions and PSAs.
1. Current Regulations Regarding Submission Dates
    We are proposing Sec.  10.31(b) because under current Sec.  
10.20(e), the submission date for documents submitted to the Division 
of Dockets Management depends on how the document is submitted to FDA. 
Current Sec.  10.20(e) states that all submissions to the Division of 
Dockets Management will be considered as submitted on the date they are 
postmarked or, if delivered in person during regular business hours, on 
the date on which they are delivered. The date considerations in 
current Sec.  10.20(e) apply unless a provision in part 10, an 
applicable Federal Register notice, or an order issued by an 
administrative law judge specifically states that the documents must be 
received by a specified date. Section 10.20(e) provides as an example 
Sec.  10.33(g), which states that a petition for reconsideration will 
be considered submitted on the date received.
    Under current Sec.  10.20(e), which applies to all citizen 
petitions submitted to the Agency, the computation of time to respond 
to a citizen petition would depend on the type of delivery service by 
which a document is sent to the Division of Dockets Management 
regardless of the date on which it is actually received by the Division 
of Dockets Management. Therefore, it is possible for two petitions to 
have different submission dates even if they are received by the 
Division of Dockets Management on the same day. For example, if 
Petition A is sent by U.S. mail, postmarked May 1, 2010, and received 
by the Division of Dockets Management on May 5, 2010, the submission 
date for Petition A would be considered to be May 1, 2010 (the date of 
postmark). If Petition B is sent by courier and hand delivered to the 
Division of Dockets Management on May 5, 2010, the submission date for 
Petition B would be considered to be May 5, 2010.
    Other part 10 regulations also relate to submission dates:
     Under Sec.  10.35(g), a PSA is considered submitted on the 
day it is received by the Division of Dockets Management. Therefore, 
under the current regulations, a document's submission date could be 
different depending on whether the document is a citizen petition or a 
PSA.
     Under Sec.  10.30(e), FDA is required to respond to a 
citizen petition within 180 days of receipt of the petition by 
approving the petition, denying the petition, or providing a tentative 
response indicating why the Agency has been unable to reach a decision; 
this 180-day deadline is based on the date of receipt by the Division 
of Dockets Management.
2. Submission Date for Petitions Submitted Under Proposed Sec.  10.31
    We believe that it is important to be clear regarding what date a 
petition submitted under Sec.  10.31 will be considered to be submitted 
because section 505(q)(1)(F) of the FD&C Act imposes a strict deadline 
for FDA to respond to a petition. Under section 505(q)(1)(F) of the 
FD&C Act, FDA must take final Agency action on a petition subject to 
section 505(q) no later than 180 days after the date on which the 
petition is submitted. The 180-day period is not to be extended for any 
reason, including any determination made under section 505(q)(1)(A) of 
the FD&C Act regarding delay of approval of an application, the 
submission of comments or supplemental information, or the consent of 
the petitioner.
    Accordingly, proposed Sec.  10.31(b) would make clear that the date 
of submission for all petitions subject to Sec.  10.31 and submitted in 
accordance with Sec. Sec.  10.20, 10.30, 10.31, and 10.35 is the date 
on which a petition is received

[[Page 27]]

by the Division of Dockets Management. We are proposing a conforming 
change to Sec.  10.20 to clarify that the method of calculating 
submission dates described in Sec.  10.20 does not apply to petitions 
subject to Sec.  10.31.

B. Certification and Verification

1. Current Regulation on Certification for Citizen Petitions
    Current Sec.  10.30 regulating citizen petitions requires that a 
citizen petition contain, among other things, a certification stating 
that the citizen petition includes all information and views on which 
the citizen petition relies and that it includes data and information 
known to the petitioner which are unfavorable to the citizen petition. 
Current regulations do not include a certification or verification 
requirement for supplements or comments to a citizen petition or 
comments to a PSA, and the current requirements are different than 
those contained in section 505(q) of the FD&C Act.
2. Certification and Verification Required by Section 505(q) of the 
FD&C Act
    Section 505(q)(1)(H) of the FD&C Act requires that any petition 
subject to section 505(q) include a specified certification. Section 
505(q)(1)(I) of the FD&C Act requires that any comments or supplemental 
information submitted to a petition subject to section 505(q) include a 
specified verification. We propose to add Sec.  10.31(c) and (d) to our 
regulation to include the statutory requirement for the submission of a 
certification and/or a verification under section 505(q) and the 
precise language of the certification and verification.
3. Proposed Certification Requirement
    Consistent with the specific language provided in section 505(q) of 
the FD&C Act, proposed Sec.  10.31(c) provides that FDA will not 
consider a petition subject to Sec.  10.31 for review unless the 
petition is in writing and contains the following certification: ``I 
certify that, to my best knowledge and belief: (a) This petition 
includes all information and views upon which the petition relies; (b) 
this petition includes representative data and/or information known to 
the petitioner which are unfavorable to the petition; and (c) I have 
taken reasonable steps to ensure that any representative data and/or 
information which are unfavorable to the petition were disclosed to me. 
I further certify that the information upon which I have based the 
action requested herein first became known to the party on whose behalf 
this petition is submitted on or about the following date: ------------ 
. If I received or expect to receive payments, including cash and other 
forms of consideration, to file this information or its contents, I 
received or expect to receive those payments from the following persons 
or organizations: ------------ . I verify under penalty of perjury that 
the foregoing is true and correct as of the date of the submission of 
this petition.''
    Proposed Sec.  10.31(c) would require that all petitions that 
request that FDA take any form of action that could, if taken, delay 
approval of an ANDA or 505(b)(2) application (i.e., petitions that are 
subject to Sec.  10.31) contain the complete certification required by 
Sec.  10.31(c) to be considered for review by FDA. If the petition does 
not contain the complete certification, we will not review the 
petition.
4. Proposed Verification Requirement
    Consistent with the specific language in section 505(q) of the FD&C 
Act, proposed Sec.  10.31(d) provides that FDA will not accept for 
review any supplemental information or comments on a petition subject 
to Sec.  10.31 unless the supplemental information or comments are in 
writing and contain the following verification: ``I certify that, to my 
best knowledge and belief: (a) I have not intentionally delayed 
submission of this document or its contents; and (b) the information 
upon which I have based the action requested herein first became known 
to me on or about ---------------- . If I received or expect to receive 
payments, including cash and other forms of consideration, to file this 
information or its contents, I received or expect to receive those 
payments from the following persons or organizations: ---------------- 
. I verify under penalty of perjury that the foregoing is true and 
correct as of the date of the submission of this document.''
    We are proposing one minor editorial change to the language of the 
verification set out in the statute. We propose to change ``I verify 
under penalty of perjury that the foregoing is true and correct as of 
the date of the submission of this petition'' to ``I verify under 
penalty of perjury that the foregoing is true and correct as of the 
date of the submission of this document'' (emphasis added). We are 
proposing this change because we believe that the statute contained a 
technical error when referring to a ``petition'' and that the obvious 
congressional intent is that this reference be to the ``document'' in 
which the verification would be contained (i.e., supplemental 
information or comments on a petition rather than a petition itself).
    Under proposed Sec.  10.31(d), if any supplemental information or 
comments that are submitted to a petition subject to Sec.  10.31 do not 
include the required verification, FDA would not review the submission.
5. Proposed Requirement That the Certification and Verification Use the 
Exact Language in the Regulation
    With the addition of proposed Sec.  10.31(c) and (d), our 
regulation would include the precise language of the required 
certification and verification. We have found that petitioners 
occasionally alter the statutory language of the certification and 
verification, thereby potentially changing the meaning intended by 
Congress when it enacted section 505(q) of the FD&C Act. To avoid any 
alteration of the meaning of the certification and verification, we are 
proposing to require that petitioners submit the exact statutory 
language of the certification and verification, with the exception 
discussed previously in section II.B.4 of this document. Because 
section 505(q) of the FD&C Act and proposed Sec.  10.31(c) set forth 
the exact words to be used in the certification, we will consider a 
certification to be deficient if every word in the petitioner's 
certification does not match every word of the certification provided 
in proposed Sec.  10.31(c). In other words, the petitioner's 
certification must correspond verbatim to the certification in proposed 
Sec.  10.31(c). For example, if a certification states ``first became 
known to me'' instead of ``first became known to the party on whose 
behalf this petition is submitted,'' the certification would be 
deficient. We believe this interpretation is required by the statutory 
language because section 505(q) of the FD&C Act specifies the exact 
text of the certification.
    As with our proposed approach to the certification, we would 
consider a verification to be deficient if it does not exactly mirror 
the words of the verification under proposed Sec.  10.31(d).
6. Date Includes Month, Day, and Year
    Section 505(q) of the FD&C Act and proposed Sec.  10.31(c) also 
require that the petitioner provide in the certification the date on or 
about which the information first became known to the party. The 
certification in proposed Sec.  10.31(c) includes a blank space for 
that information. We interpret the FD&C Act's reference to ``date'' to 
mean a month, day, and year. Therefore, we propose to consider a 
certification to be deficient if the petitioner has not provided the 
month, day, and year on or

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about which the information first became known to the party on whose 
behalf the petition is submitted. For example, if the petitioner 
provides ``May 2010'' as the date in the certification, we would 
consider the certification to be deficient. The text of the 
certification provided in proposed Sec.  10.31(c) includes a 
qualification that the petitioner learned of the information on or 
about the following date; therefore, we believe the certification would 
accommodate instances in which a petitioner may not know the exact date 
on which it became aware of the information.
    Similarly, under proposed Sec.  10.31(d), we are proposing that if 
the petitioner or commenter does not provide a month, day, and year in 
the verification, FDA will consider the verification to be deficient 
and will not review the submission.
7. Multiple Dates and Types of Information
    FDA recognizes that a petition, supplement, or comment could be 
based on more than one type of information. Proposed Sec.  10.31(c)(2) 
would require a petitioner to provide in the certification an estimated 
relevant date for each type of information if different types of 
information became known over a period of time. The petitioner must 
identify the information associated with the particular date. To the 
extent that a petitioner believes that additional clarification is 
appropriate, the blank space in the certification that proposed Sec.  
10.31(c) designates for the date could accommodate additional 
information that the petitioner believes is appropriate to explain the 
date that it has identified. This would be done by providing, in each 
case in which more than one type of information is relied on, the date 
followed by an identification of the information associated with that 
date in parentheses. Thus, for example, a petition might include the 
following in the space for the date:
    September 21, 1995 (information about bioavailability issues with 
the innovator drug);
    November 12, 2009 (publication of a draft bioequivalence guidance 
for the drug);
    March 30, 2010 (information that an ANDA had been submitted).
    When adding additional information, the petitioner should ensure 
that the words of the certification (except for information added in 
the blank space provided) continue to exactly match the words of the 
certification as provided by proposed Sec.  10.31(c).
    Similarly, proposed Sec.  10.31(d) would require that the 
petitioner or commenter include in the verification each type of 
information and supply the date each type of information became known. 
The verification in proposed Sec.  10.31(d) includes a blank space that 
can accommodate this information.
    Under proposed Sec.  10.31(c) and (d), it is the responsibility of 
the person submitting the petition, supplemental information, or 
comment to identify each type of information upon which it relies and 
to supply a date with respect to each such type of information. The 
failure to provide any information relied upon (and the date) in the 
certification or verification may result in the failure of FDA to 
consider that information in its analysis of the petition and would, 
FDA believes, foreclose the petitioner or the person submitting the 
supplemental information or comment from relying upon such information 
in judicial review of FDA's final decision.
8. Petitions That Would Be Required To Include the 505(q) Certification
    Proposed Sec.  10.31 would apply to all petitions that request an 
action that could delay the approval of a possible ANDA or 505(b)(2) 
application (proposed Sec.  10.31(a)); therefore, all such petitions 
would be required to include the certification proposed in Sec.  
10.31(c).
    Because section 505(q)(1)(A) of the FD&C Act specifically 
references pending ANDA or 505(b)(2) applications, we interpret section 
505(q) to apply only to petitions for which, at the time the petition 
is submitted, at least one ANDA or 505(b)(2) application related to the 
subject matter of the petition is pending. If there is no related ANDA 
or 505(b)(2) application pending at the time that the petition is 
submitted, then we will not consider the provisions of section 505(q) 
of the FD&C Act to apply to the petition. We believe this 
interpretation of section 505(q) of the FD&C Act is appropriate because 
if no related ANDA or 505(b)(2) application is pending at the time that 
a petition is submitted, the references in section 505(q)(1)(A) to a 
pending application and delay of approval by a petition would be 
inapplicable. With respect to the actual submission of the 
certification and/or verification with a petition, we recognize that 
petitioners may not be aware of the existence of a pending ANDA or 
505(b)(2) application and, therefore, may not know whether to submit 
the appropriate certification and/or verification under section 505(q) 
of the FD&C Act. Generally, the existence of an ANDA or a 505(b)(2) 
application would not be public information.\1\ Therefore, FDA has 
recommended that any petitioner challenging the approvability of an 
ANDA or a 505(b)(2) application include the statutory certification to 
avoid a situation in which a petition that is subject to section 505(q) 
of the FD&C Act is missing the certification and therefore cannot be 
reviewed by FDA under the statute. We have stated that in situations 
where a petitioner submits such a petition, we recommend that the 
petitioner withdraw the original petition and resubmit a petition that 
includes the required certification under section 505(q) of the FD&C 
Act.
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    \1\ Although the existence of a pending application generally is 
not made public by FDA, a potential petitioner may be aware of the 
existence of a pending ANDA or 505(b)(2) application because of: (1) 
A paragraph IV patent notification, from the applicant to the NDA 
holder and the patent owner, stating that the application has been 
submitted and explaining the factual and legal bases for the 
applicant's opinion that the patent is invalid or will not be 
infringed (see section 505(b)(2)(B) and (j)(2)(B) of the FD&C Act), 
(2) a public announcement by the applicant disclosing the submission 
of the application, or (3) the tentative approval of an ANDA or 
505(b)(2) application made public by FDA or the applicant. In 
addition, FDA's Web site identifies drug products for which the 
Agency has received an ANDA with a paragraph IV certification.
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    We have also stated that although we may contact a petitioner to 
notify him or her of a missing or deficient certification, it is the 
responsibility of the petitioner to ensure that his or her petition 
complies with the applicable requirements of section 505(q) of the FD&C 
Act as well as all other applicable statutory and regulatory 
requirements. Contacting petitioners who have submitted deficient 
petitions represents an administrative burden for the Agency. In 
addition, we are concerned that our contacting such petitioners could 
notify the petitioner and the public that an ANDA or 505(b)(2) 
application for a particular drug product is pending.
    By including in proposed Sec.  10.31(a) all petitions that 
challenge the approvability of a possible ANDA or 505(b)(2) 
application, all such petitions would be required to include the 
certification in proposed Sec.  10.31(c). Proposed Sec.  10.31(a) would 
eliminate the need for FDA to contact a petitioner to advise him or her 
that the petition must include the 505(q) certification or avoid a 
delay in dealing with the specific issues contained in a petition 
because the petitioner must withdraw and resubmit the petition. In 
addition, we propose that any supplement or comments to a petition that 
is subject to proposed Sec.  10.31 and that includes the certification 
in Sec.  10.31(c) must include the verification in Sec.  10.31(d).

[[Page 29]]

C. Dismiss Petition as Moot

    Although the primary purpose of this rule is to implement section 
505(q) of the FD&C Act, we are proposing to add language to Sec.  
10.30(e) to allow the Commissioner to dismiss a petition as moot. 
Because we are making changes to Sec.  10.30 to implement section 
505(q) of the FD&C Act, we believe it would be useful to make this 
minor clarifying change to the regulations. This change is technical in 
nature and would be applicable to citizen petitions in general, 
including those subject to section 505(q) of the FD&C Act. Current 
Sec.  10.30(e) could be read to require that the Commissioner respond 
to a citizen petition by either granting or denying the requests in the 
citizen petition, even when circumstances have rendered the requests in 
the petition moot. Current Sec.  10.30(e) does not by its terms 
contemplate a situation in which a petition can be dismissed as moot.
    Because changes in law, facts, or circumstances occurring after a 
citizen petition is submitted to the Agency can render the requests 
contained in a petition moot, we propose to allow the Commissioner to 
dismiss a petition as moot in these situations. An example of a moot 
petition would be a petition that requests that the Agency remove a 
particular drug from the market for safety reasons when, at the time of 
the response, the drug has already been removed from the market. 
Another example would be where a petitioner requests a change to a 
regulation that has been rescinded or withdrawn since the petition was 
submitted. In such circumstances, it would be appropriate for the 
Commissioner to dismiss the petition as moot rather than to grant or 
deny the requests in the petition. This proposed change to our 
regulations is intended to clarify that, in addition to our authority 
to grant or deny a petition under our current regulations, the Agency 
can dismiss citizen petitions as moot in certain circumstances.
    When a citizen petition is dismissed as moot, FDA would respond to 
the petitioner in writing just as we would when granting or denying a 
petition. We believe, however, that the Agency's justification for 
dismissing a petition as moot could be brief in comparison to a 
response granting or denying a petition, and thus would require 
dedication of fewer Agency resources. FDA's response dismissing a 
citizen petition as moot, similar to a response granting or denying a 
petition, would constitute final Agency action as to that citizen 
petition.

D. Petitions for Stay of Action

    We are proposing a conforming change to Sec.  10.35(b) to clarify 
the applicable regulations for PSAs that are subject to section 505(q) 
of the FD&C Act. Section 10.35(b) currently states that ``a request for 
stay must be submitted in accordance with Sec.  10.20 and in the 
following form no later than 30 days after the date of the decision 
involved.'' We propose to add language to Sec.  10.35(b) to provide 
that petitions for stay subject to Sec.  10.31 must include the 
certification provided in Sec.  10.31(c). This proposed revision would 
alert petitioners for stays of action that may be subject to section to 
505(q) of the FD&C Act that they must also submit the certification in 
Sec.  10.31(c).
    Section 505(q)(1)(A) of the FD&C Act states that FDA must not delay 
approval of a pending ANDA or 505(b)(2) application because of any 
request to take any form of action relating to the application unless 
the request is in writing, is a citizen petition submitted under Sec.  
10.30 or a PSA submitted under Sec.  10.35, and FDA determines, upon 
reviewing the petition, that a delay is necessary to protect the public 
health. Section 10.35(d) provides that filing a PSA, citizen petition, 
or other type of petition, or taking another type of action as 
described in Sec.  10.35(d) will not stay or otherwise delay any 
administrative action by the Commissioner unless: (1) The Commissioner 
determines that a stay or delay is in the public interest and stays the 
action, (2) a statute requires that the matter be stayed, or (3) a 
court orders that the matter be stayed. In other words, the mere filing 
of any petition, including a petition under section 505(q) of the FD&C 
Act, would not stay or otherwise delay administrative action by FDA. 
See TMJ Implants, Inc. v. United States HHS, 584 F.3d 1290, 1300 (10th 
Cir. 2009). A delay of an administrative action could only occur if FDA 
chose to take action in response to a particular submission. We are not 
proposing any changes to Sec.  10.35(d) to implement section 
505(q)(1)(A) of the FD&C Act because we believe that the provisions of 
section 505(q)(1)(A) of the FD&C Act regarding the circumstances in 
which FDA would stay or delay an administrative action (e.g., approval 
of an ANDA or 505(b)(2)) would be covered by the current language of 
Sec.  10.35(d).
    As explained previously in this document with respect to citizen 
petitions under Sec.  10.30(e)(3), we are proposing to add a sentence 
to Sec.  10.35(e) to allow the Commissioner to dismiss a petition for 
stay of action as moot.
    In addition, we are proposing to add Sec.  10.35(i), which would 
mirror Sec.  10.30(g) governing citizen petitions and allow a 
petitioner who has submitted a PSA to supplement, amend, or withdraw a 
PSA without Agency approval and without prejudice, unless the PSA has 
been referred for a hearing under 21 CFR parts 12, 13, 14, or 15. 
Proposed Sec.  10.35(i) would apply to all PSAs, not just PSAs subject 
to section 505(q) of the FD&C Act. We believe that adding this 
provision to allow PSAs to be amended, withdrawn, or supplemented is 
permitted under the FD&C Act and is appropriate to allow petitioners 
submitting PSAs the same procedural rights as petitioners submitting 
citizen petitions. By amending this regulation, we are clarifying that 
it is permissible to amend, withdraw, or supplement a PSA because the 
current regulations are not specific on this point and our current 
practice allows a PSA to be amended, withdrawn, or supplemented. 
Furthermore, under section 505(q)(1)(I) of the FD&C Act, the 
verification statement that applies to citizen petitions and PSAs 
refers to supplemental information. Therefore, in drafting this 
provision, Congress assumed it was possible to provide a supplement to 
a PSA.

E. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 60 days after its publication in the Federal 
Register. FDA seeks public comment on its proposed 60-day effective 
date for any final rule that may issue based on this proposed rule.

III. Legal Authority

    This rule, if finalized, would amend Sec. Sec.  10.20, 10.30, and 
10.35 and add new Sec.  10.31 in a manner consistent with the Agency's 
current understanding and application of these provisions. FDA is 
implementing certain provisions of FDAAA that govern petitions subject 
to section 505(q) of the FD&C Act. FDA has authority to issue 
regulations for the efficient administration of these provisions under 
section 701(a) of the FD&C Act (21 U.S.C. 371(a)).

IV. Environmental Impact

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

[[Page 30]]

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this final rule is not a significant 
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the annualized compliance costs to 
individual industry members who submit a petition is estimated to be 
about $100, the Agency proposes to certify that the final rule will not 
have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect any 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

A. Purpose of the Proposed Rule

    Section 505(q) of the FD&C Act concerns the manner in which FDA 
handles certain citizen petitions and PSAs that request that the Agency 
take some action related to a pending 505(b)(2) application or 505(j) 
application (ANDA). Congress was concerned that some petitions may 
improperly delay the approval of an application if they are submitted 
late in the review process and do not contain valid scientific, legal, 
or public health issues. The provisions contained in section 505(q) of 
the FD&C Act are self-implementing, and FDA has operated under these 
requirements since FDAAA became law in September 2007. This proposed 
rule would codify the certification and verification requirements 
included in section 505(q) of the FD&C Act extend these requirements to 
all petitions challenging the approvability of possible ANDAs and 
505(b)(2) applications, as well as those submitting supplements and 
comments to these petitions, clarify how FDA determines the date of 
submissions for citizen petitions and PSAs subject to section 505(q), 
and clarify that a petitioner for a PSA may supplement, amend, or 
withdraw a PSA in a manner similar to that provided in the provisions 
for citizen petitions. In addition, the proposed rule would allow the 
Commissioner to dismiss a citizen petition or PSA as moot in certain 
circumstances.

B. Benefits of the Proposed Rule

    Section 505(q) of the FD&C Act was enacted in light of concerns 
that some citizen petitions were submitted to delay the approval of 
ANDAs or 505(b)(2) applications. With the enactment of FDAAA, FDA is 
required to take final action on a 505(q) petition within 180 days of 
its receipt. Further, the law requires that an expanded certification 
statement be included with petitions, and a verification statement be 
included with supplements and comments to petitions. While these 
requirements do not specifically preclude anyone from submitting a 
petition that may delay approval of an ANDA or 505(b)(2) application, 
the requirement that the person submitting the document reveal the date 
on which he or she became aware of the information contained in the 
petition is presumably intended to reduce this type of behavior.
    The requirements contained in section 505(q) of the FD&C Act have 
been in effect for 3 years. FDA received 21 505(q) petitions in fiscal 
year (FY) 2008, 31 505(q) petitions in FY 2009, and 20 505(q) petitions 
in FY 2010. Over the same period, however, the number of ANDAs and 
505(b)(2) applications whose approvals were delayed decreased slightly, 
from 2 in FY 2008 to 1 in FY 2009 and 1 in FY 2010. The sample size of 
only 3 years is too small to conclusively determine whether the statute 
has caused a reduction in the number of petitions that did not include 
valid scientific or legal issues whose primary purpose was to delay 
approval of an application. The existence of the statutory requirement 
that FDA take final action within 180 days of receipt of a 505(q) 
petition, consequently reducing delays of approval, may have had this 
effect by itself.
    By codifying the certification and verification statements (with a 
minor technical change to the verification language), the proposed rule 
would reinforce the need for exact wording of both the certification 
and verification statements. Further, the proposed rule makes clear 
that each of these two statements requires the identification of a 
month, day, and year in the place of the date, as opposed to just a 
year or a month and year. In addition, the proposed rule would clarify 
that each individual type of information requires its own separate 
date. By providing additional clarity on the statutory requirements, 
this proposed rule would likely reduce the number of deficient 505(q) 
petitions. FDA does not have enough information to estimate this 
reduction in deficient 505(q) petitions, but believes it will result in 
lower administrative costs for both industry and FDA.

C. Costs of the Proposed Rule

1. Industry Labor Costs
    Companies involved in pharmaceutical research and manufacturing 
would incur labor costs due to the rule through their administrative 
review of the final rule and determination of their compliance 
responsibilities. All companies involved in this would incur some labor 
costs, regardless of the frequency of their submission of ANDAs or 
505(b)(2) applications or citizen petitions to FDA. Census data from 
2007 list 763 companies in its pharmaceutical preparation manufacturing 
category. FDA estimates that each company will expend about 4 hours to 
review the final rule and determine any changes it needs to make to its 
internal administrative policies due to this rule. The pharmaceutical 
and medicine manufacturing category of the North American Industrial 
Classification System (NAICS) lists the hourly wage for a manager in 
this category at about $54. A 35-percent adjustment to this figure for 
employee benefits results in total hourly compensation costs of about 
$73. A one-time 4-hour review for each company would result in 
compliance costs of almost $300 per company, and a total of about 
$224,000 for the industry. This equates to an annualized cost (over 5 
years at a 7-percent discount rate) of about $55,000 for the entire 
industry. These estimates may overstate true compliance costs for 
review of the rule because companies that are unlikely to submit 
citizen petitions on even an occasional basis

[[Page 31]]

may not expend as much labor as those that submit petitions more often. 
FDA invites comment on the estimate of 4 hours of labor to review the 
final rule and make any adjustment to company policies.
    Additional labor costs of the rule would be incurred due to the new 
requirement that all petitioners challenging the approvability of a 
possible ANDA or 505(b)(2) application for which an application is not 
currently pending at FDA submit the appropriate certification, as well 
as the requirement that any supplements or comments to these petitions 
include the verification. The implementation of the requirements that 
505(q) petitions (concerning the approvability of a pending ANDA or 
505(b)(2) application) use the new certification language and that 
supplements and comments to these petitions use the verification 
language began with the enactment of FDAAA in September 2007 and are 
not the subject of the proposed rule. FDA has previously estimated that 
the statute would result in about 28 additional certifications with 
petitions and 25 additional verifications with supplements or comments 
to petitions.
    FDA received a yearly average of 32 petitions that challenged the 
approvability of a possible ANDA or 505(b)(2) application since the end 
of 2007. This number represents a very small increase over the average 
for the previous 4-year period. Of these 32 petitions, on average only 
25 were 505(q) petitions. FDA uses the difference between these two 
numbers, or about seven petitions per year, as its estimate of the 
number of additional petitions that this proposed rule would require to 
comply with the 505(q) requirements for certification. FDA estimates 
that the additional time needed to prepare the certification language 
in the proposed rule at 30 minutes. The majority of this time 
represents the additional effort of determining the date on which the 
information or data included in the petition became known to the person 
submitting the petition. FDA uses the same pharmaceutical and medicine 
manufacturing category of the NAICS hourly wage for a manager (adjusted 
for benefits) of $73 to calculate this cost. At 30 minutes per 
petition, the marginal cost to prepare the additional certification 
language for 1 petition is estimated at $37. For the average of seven 
additional petitions that would need the additional language, the total 
cost to industry is estimated at about $250 annually.
    Additional labor costs would also be incurred for the preparation 
of certifications for supplements and comments to petitions that 
challenge the approvability of ANDA applications and 505(b)(2) 
applications for which there is no pending application at the time of 
the supplement or comment submission. FDA previously estimated that it 
would receive about 9 verifications for every 10 certifications in the 
implementation of the 505(q) provision. Using this ratio, FDA estimates 
that this proposed rule would result in the submission of verifications 
amounting to 90 percent of the additional certifications that it 
received due to this rule. Since FDA estimated that 7 additional 
certifications would be submitted due to this rule, FDA estimates that 
90 percent of this number, or about 6 verifications, would also be 
submitted as a result of this rule. At 30 minutes per petition and the 
same adjusted wage rate of $73/hour, the additional cost per 
verification is estimated at $37. The additional labor costs for the 6 
verifications would total to about $220 per year.
    The provision of the proposed rule that would allow a petitioner 
who has submitted a PSA to supplement, amend, or withdraw a PSA without 
Agency approval would not impose any marginal costs on industry 
members. These practices reflect FDA's current policy. Similarly, the 
provision of this proposed rule that clarifies how FDA determines the 
submission date for documents received by FDA's Division of Docket 
Management is also not expected to impose any costs on industry 
members.
    The total one-time costs plus annual costs of this proposed rule 
are estimated at about $224,000, with annualized costs (one-time costs 
annualized over 5 years at a 7-percent discount rate plus annual costs) 
at about $55,000 for the entire industry (see table 1 of this 
document). This estimate reflects a one-time $300 per company review 
cost for each industry member (annualized over 5 years at a 7-percent 
discount rate at about $70), plus an additional $37 labor cost per 
certification or verification submitted.

                                       Table 1--Industry Compliance Costs
----------------------------------------------------------------------------------------------------------------
                                                                                                Annualized costs
                    Labor cost factors                       One-time costs     Annual costs           \1\
----------------------------------------------------------------------------------------------------------------
Final Rule Review.........................................          $223,600  ................           $55,000
Certification Preparation.................................  ................              $250               250
Verification Preparation..................................  ................               200               200
                                                           -----------------------------------------------------
    Total Costs...........................................  ................  ................            55,450
----------------------------------------------------------------------------------------------------------------
\1\ Annualized costs represent one-time costs amortized over 5 years at a 7-percent discount rate plus annual
  costs. At a 3-percent discount rate, annualized costs are reduced by about $5,400.

2. Costs to the Government
    The costs to government for oversight of this proposed rule would 
be low as a review of the language in an additional seven 
certifications included with petitions and six verifications included 
with supplements or comments to petitions would only require 15 minutes 
for each. FDA believes this cost would not be significant, and 
emphasizes that the FDA personnel reviewing and responding to citizen 
petitions spend the vast majority of the time on the substantive issues 
included in the documents.

D. Small Business Impact

    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because of the very low costs that would be incurred 
by an individual company submitting a petition or supplement or comment 
to a petition, FDA believes that the proposed rule would not have a 
significant economic impact on a substantial number of small 
manufacturing entities.
    The companies that would be affected by this proposed rule are 
classified in two NAICS categories by the Census Bureau. The affected 
industries are NAICS 325412--Pharmaceutical Preparation, and NAICS 
325414--Biological Products (except diagnostic). The Small Business 
Administration

[[Page 32]]

(SBA) defines small entities in the pharmaceutical preparation category 
as those with less than 750 employees and defines small entities in the 
biological product (except diagnostic) category as those with less than 
500 employees. The most recent Census of Manufactures data that offer 
the level of detail for establishments at or near the employee size 
limits as defined by SBA is from 2002. In both of these establishment 
size categories, large majorities of the establishments meet the 
criteria as small entities. Even taking into account that many of these 
establishments are parts of multi-establishment corporations, 
significant numbers of companies would still qualify as small entities. 
Preliminary Census data from 2007, though less detailed, show that 
significant numbers of establishments continue to have fewer than 100 
employees across all of these categories. While FDA expects that most 
companies submitting petitions that challenge the approvability of an 
ANDA or 505(b)(2) application would be larger than the average-sized 
company in their industry, FDA concludes that a substantial number of 
companies would still qualify as small entities.
    The cost analysis concluded that the annualized compliance cost of 
the proposed rule for a company that submitted one additional 
certification as a result of the rule would be just over $100. Because 
FDA estimates that only about seven additional certifications will be 
submitted due to this rule, it is doubtful that many firms will submit 
more than one additional certification or verification annually to 
those already required by section 505(q) of the FD&C Act. Using 2002 
Census data, the average value of shipments for establishments in these 
industries with 1 to 4 employees ranged from $478,000 to $824,000 
according the Census of Manufactures. Assuming that such small 
operations had to prepare even one additional certification or 
verification each year, the costs of the proposed rule would represent, 
at most, 0.02 percent of the annual value of shipments. For 
establishments with 10 or more employees, the compliance costs would 
represent 0.01 percent or less of the value of shipments. As stated 
previously, FDA concludes that this proposed rule would not have a 
significant economic impact on a substantial number of small entities.

VI. Paperwork Reduction Act

    This proposed rule contains collections of information that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (the 
PRA) (44 U.S.C. 3501-3520). ``Collection of information'' includes any 
request or requirement that persons obtain, maintain, retain, or report 
information to the Agency, or disclose information to a third party or 
to the public (44 U.S.C. 3502(3) and 5 CFR 1320.3(c)). The title, 
description, and respondent description of the information collection 
are shown under this section with an estimate of the annual reporting 
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 the 
collection of information.
    FDA invites comments on these topics: (1) Whether the collection of 
information is necessary for 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 proposed 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: Amendments to Regulations on Citizen Petitions, Petitions 
for Stay of Action, and Submission of Documents to Dockets.
    Description of Respondents: Respondents to this collection of 
information as it is related to citizen petitions are individuals or 
households, State or local governments, not-for-profit institutions, 
and businesses or other for-profit institutions or groups. Respondents 
to this collection of information as it is related to PSAs are persons 
who choose to file a petition for an administrative stay of action.
    Description: FDA is requesting public comment on estimates of 
annual submissions from these respondents, as required by section 
505(q) of the FD&C Act and described in this proposed rule under Sec.  
10.31(c) and (d). Section 10.31(c) of this proposed rule requires that 
citizen petitions and PSAs that are subject to section 505(q) include a 
certification to be considered for review by FDA. Section 10.31(d) 
requires that supplemental information or comments to such citizen 
petitions and PSAs include a verification to be accepted for review by 
FDA. This proposed rule sets forth the statutory language under section 
505(q) requiring the submission of a certification and/or a 
verification and the precise language of the certification and 
verification. One of the criteria for a citizen petition or PSA to be 
subject to section 505(q) is that a related ANDA or 505(b)(2) 
application is pending at the time the citizen petition or petition for 
stay is submitted. Because petitioners or commenters may not be aware 
of the existence of a pending ANDA or 505(b)(2) application, this 
proposed rule requires that all petitioners challenging the 
approvability of a possible ANDA or 505(b)(2) application include the 
certification required in Sec.  10.31(c) of this proposed rule and that 
petitioners and commenters submitting supplements or comments, 
respectively, to a citizen petition or PSA challenging the 
approvability of a possible ANDA or 505(b)(2) application include the 
verification required in section Sec.  10.31(d) of this proposed rule.
    FDA currently has OMB approval for the collection of information 
entitled ``General Administrative Procedures: Citizen Petitions; 
Petition for Reconsideration or Stay of Action; Advisory Opinions'' 
(OMB control number 0910-0183). This collection of information 
includes, among other things: (1) The format and procedures by which an 
interested person may submit to FDA, in accordance with Sec.  10.20, a 
citizen petition requesting the Commissioner to issue, amend, or revoke 
a regulation or order, or to take or refrain from taking any other form 
of administrative action (Sec.  10.30(b)); (2) the submission of 
written comments on a filed citizen petition (Sec.  10.30(d)); (3) the 
submission of a supplement or amendment to or a letter to withdraw a 
filed citizen petition (Sec.  10.30(g)); (4) the format and procedures 
by which an interested person may request, in accordance with Sec.  
10.20, the Commissioner to stay the effective date of any 
administrative action (Sec.  10.35(b)); and (5) the submission of 
written comments on a filed petition for administrative stay of action 
(Sec.  10.35(c)). This information collection includes citizen 
petitions, PSAs, comments to petitions, supplements to citizen 
petitions, and letters to withdraw a citizen petition, as described 
previously, that are subject to section 505(q) of the FD&C Act and 
described in this proposed regulation.
    OMB recently approved (OMB control number 0910-0679) the 
information collection in the guidance for industry entitled ``Citizen 
Petitions and Petitions for Stay of Action Subject to Section 505(q) of 
the Federal Food, Drug, and Cosmetic Act'' (see the information 
collection analysis at 75 FR 78249 (December 15, 2010), and the 
document announcing the availability of the guidance at 76 FR 33309 
(June 8, 2011)).

[[Page 33]]

The guidance describes FDA's interpretation of section 505(q) of the 
FD&C Act regarding how the Agency will determine if: (1) The provisions 
of section 505(q) addressing the treatment of citizen petitions and 
petitions for stay of Agency action (collectively, petitions) apply to 
a particular petition and (2) a petition would delay approval of a 
pending ANDA or a 505(b)(2) application. The guidance also describes 
how FDA will interpret the provisions of section 505(q) requiring that: 
(1) A petition include a certification and (2) supplemental information 
or comments to a petition include a verification. Finally, the guidance 
addresses the relationship between the review of petitions and pending 
ANDAs and 505(b)(2) applications for which the Agency has not yet made 
a decision on approvability.
    Thus, FDA has OMB approval under the PRA for the information 
collection required under section 505(q) of the FD&C Act and described 
in the guidance. This information collection is also described in 
proposed Sec.  10.31(c) and (d).
    There is, however, one proposed provision that would require the 
collection of information that is not already approved by OMB. Under 
proposed Sec.  10.35(i), a petitioner may, under certain conditions, 
supplement, amend, or withdraw a PSA in writing without Agency approval 
and without prejudice to resubmission at any time until the 
Commissioner rules on the petition. This proposed provision is 
explained in section II of this document. FDA estimates that it will 
receive approximately one supplement, amendment, or withdrawal under 
proposed Sec.  10.35(i) from approximately one applicant, and that it 
will take approximately 0.5 hour to make this submission.

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of     Annual frequency    Total annual        Hours per
                                                                   respondents      per response        responses         response         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed Sec.   10.35(i)......................................                 1                 1                 1               0.5               0.5
                                                               -----------------------------------------------------------------------------------------
    Total Hours...............................................  ................  ................  ................  ................               0.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The information collection provisions of this proposed rule have 
been submitted to OMB for review. Interested persons are requested to 
fax comments regarding information collection by (see DATES section of 
this document) to the Office of Information and Regulatory Affairs, 
OMB. To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: (202) 395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should reference the title of this proposed rule and include 
the FDA docket number found in brackets in the heading of this 
document.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

VIII. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management 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