Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 3611 

individuals may submit one paper 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 Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder.guidance/ 

index.htm, http://www.fda.gov/cber/ 

guidelines.htm or http:// 

www.regulations.gov. 

Dated: January 12, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–936 Filed 1–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0008] 

Draft Guidance for Industry on Citizen 

Petitions and Petitions for Stay of 

Action Subject to Section 505(q) of the 

Federal Food, Drug, and Cosmetic Act; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 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.’’ The Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) added new provisions 

to the Federal Food, Drug, and Cosmetic 

Act (the act) addressing the agency’s 

treatment of certain citizen petitions 

and petitions for stay of agency action 

(collectively, petitions), as well as 

related applications. The draft guidance 

describes how FDA will determine if the 

new provisions apply to a particular 

petition and how FDA will determine if 

a petition would delay approval of a 

pending abbreviated new drug 

application (ANDA) or 505(b)(2) 

application. The draft guidance also 

describes how FDA will interpret the 

requirements that such petitions include 

a certification and that supplemental 

information or comments to such 

petitions include a verification. The 

draft guidance also addresses the 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. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance, including comments 

regarding the proposed collection of 

information, by March 23, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Boocker, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6244, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft 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.’’ The draft guidance provides 

information regarding FDA’s current 

thinking on interpreting section 914 of 

Title IX of FDAAA (Public Law 110–85). 

Section 914 of FDAAA added new 

section 505(q) to the act (21 U.S.C. 

355(q)) and governs certain citizen 

petitions and petitions for stay of agency 

action that request that FDA take any 

form of action related to a pending 

application submitted under section 

505(b)(2) or 505(j) of the act. The draft 

guidance describes FDA’s interpretation 

of section 505(q) of the 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 

draft 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 draft 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. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on citizen petitions and petitions for 

stay of action that are subject to section 

505(q) of the act. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper 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 Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

(44 U.S.C. 3501–3520) (the PRA), 

Federal agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

mstockstill on PROD1PC66 with NOTICES

3612 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed 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 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: Citizen Petitions and Petitions 

for Stay of Action Subject to Section 

505(q) of the Federal Food, Drug, and 

Cosmetic Act. 

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-forprofit institutions, and businesses or 

other for-profit institutions or groups. 

Respondents to this collection of 

information as it is related to petitions 

for stay of agency action are persons 

who choose to file a petition for an 

administrative stay of action. 

Burden Estimate: FDA is requesting 

public comment on estimates of annual 

submissions from these respondents, as 

required by section 505(q) of the act and 

described in this draft guidance. Section 

505(q)(1)(H) of the act requires that 

citizen petitions and petitions for stay of 

agency action that are subject to section 

505(q) include a certification to be 

considered for review by FDA. Section 

505(q)(1)(I) of the act requires that 

supplemental information or comments 

to such citizen petitions and petitions 

for stay of agency action include a 

verification to be accepted for review by 

FDA. The draft guidance describes our 

current thinking on the interpretation of 

these requirements. The draft guidance 

sets forth the criteria the agency will use 

in determining if the provisions of 

section 505(q) apply to a particular 

citizen petition or petition for stay of 

agency action. One of the criteria for a 

citizen petition or petition for stay of 

agency action to be subject to section 

505(q) of the act 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, the draft 

guidance recommends that all 

petitioners challenging the 

approvability of a possible ANDA or 

505(b)(2) application include the 

certification required in section 

505(q)(1)(H) of the act and that 

petitioners and commenters submitting 

supplements or comments, respectively, 

to a citizen petition or petition for stay 

of action challenging the approvability 

of a possible ANDA or 505(b)(2) 

application include the verification 

required in section 505(q)(1)(I) of the 

act. The draft guidance also 

recommends that if a petitioner submits 

a citizen petition or petition for stay of 

agency action that is missing the 

required certification but is otherwise 

within the scope of section 505(q) of the 

act and the petitioner would like FDA 

to review the citizen petition or petition 

for stay of agency action, the petitioner 

should submit a letter withdrawing the 

deficient petition and submit a new 

petition that contains the required 

certification. 

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 

§ 10.20 (21 CFR 10.20), a citizen petition 

requesting the Commissioner of Food 

and Drugs (Commissioner) to issue, 

amend, or revoke a regulation or order, 

or to take or refrain from taking any 

other form of administrative action 

(§ 10.30(b) (21 CFR 10.30(b))); (2) the 

submission of written comments on a 

filed citizen petition (§ 10.30(d)); (3) the 

submission of a supplement or 

amendment to or a letter to withdraw a 

filed citizen petition (§ 10.30(g)); (4) the 

format and procedures by which an 

interested person may request, in 

accordance with § 10.20, the 

Commissioner to stay the effective date 

of any administrative action (§ 10.35(b) 

(21 CFR 10.35(b))); and (5) the 

submission of written comments on a 

filed petition for administrative stay of 

action (§ 10.35(c)). This information 

collection includes citizen petitions, 

petitions for administrative stay of 

action, comments to petitions, 

supplements to citizen petitions, and 

letters to withdraw a citizen petition, as 

described above, that are subject to 

section 505(q) of the act and described 

in the draft guidance. 

Under section 505(q) of the act and 

the draft guidance, the following 

information would be submitted to FDA 

but is not currently approved by OMB 

under the PRA: 

1. The certification required under 

section 505(q)(1)(H) of the act for citizen 

petitions that are subject to section 

505(q) and/or that are challenging the 

approvability of a possible ANDA or 

505(b)(2) application. Although the 

submission of a certification for citizen 

petitions is approved under OMB 

Control Number 0910–0183, the 

certification would be broadened under 

section 505(q) of the act and the draft 

guidance. 

2. The certification required under 

section 505(q)(1)(H) of the act for 

petitions for stay of action that are 

subject to section 505(q) and/or that are 

challenging the approvability of a 

possible ANDA or 505(b)(2) application. 

3. The verification required under 

section 505(q)(1)(I) of the act for 

comments to citizen petitions. 

4. The verification required under 

section 505(q)(1)(I) of the act for 

comments to petitions for stay of agency 

action. 

5. The verification required under 

section 505(q)(1)(I) of the act for 

supplements to citizen petitions. 

6. Supplements to petitions for stay of 

agency action and the verification 

required under section 505(q)(1)(I) of 

the act. 

7. The letter submitted by a petitioner 

withdrawing a deficient petition for stay 

of agency action that is missing the 

required certification but is otherwise 

within the scope of section 505(q) of the 

act. 

Section 505(q)(1)(B) and (C) of the act 

and the draft guidance state that if FDA 

determines that a delay in approval of 

an ANDA or 505(b)(2) application is 

necessary based on a petition subject to 

section 505(q) of the act, the applicant 

may submit to the petition docket 

clarifications or additional data to allow 

FDA to review the petition promptly. 

This information collection is not 

included in this analysis because it is 

approved under OMB Control Number 

0910–0001 (21 CFR 314.54, 314.94, and 

314.102). 

Based on FDA’s knowledge of citizen 

petitions and petitions for stay of agency 

action subject to section 505(q) of the 

act that have been submitted since 

September 27, 2007, as well as the 

agency’s familiarity with the time 

needed to prepare a certification and a 

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Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 3613 

verification, our estimates for this 

information collection are as follows: 

1. The certification currently 

submitted for a citizen petition would 

be broadened under section 505(q) of 

the act and the draft guidance. FDA 

estimates that it will receive annually 

approximately 25 certifications under 

section 505(q)(1)(H) of the act for citizen 

petitions that are subject to section 

505(q) and/or that are challenging the 

approvability of a possible ANDA or 

505(b)(2) application. FDA estimates 

that approximately 19 respondents will 

submit these certifications and that each 

certification will take approximately 30 

minutes to prepare. 

2. FDA estimates that it will receive 

annually approximately three 

certifications under section 505(q)(1)(H) 

of the act for petitions for stay of action 

that are subject to section 505(q) and/or 

that are challenging the approvability of 

a possible ANDA or 505(b)(2) 

application. FDA estimates that 

approximately three respondents will 

submit these certifications and that each 

certification will take approximately 30 

minutes to prepare. 

3. FDA estimates that it will receive 

annually approximately 12 verifications 

required under section 505(q)(1)(I) of 

the act for comments to citizen 

petitions. FDA estimates that 

approximately nine respondents will 

submit these verifications, and that each 

verification will take approximately 30 

minutes to prepare. 

4. FDA estimates that it will receive 

annually approximately two 

verifications required under section 

505(q)(1)(I) of the act for comments to 

petitions for stay of agency action. FDA 

estimates that approximately two 

respondents will submit these 

verifications and that each verification 

will take approximately 30 minutes to 

prepare. 

5. FDA estimates that it will receive 

annually approximately 10 verifications 

required under section 505(q)(1)(I) of 

the act for supplements to citizen 

petitions. FDA estimates that 

approximately seven respondents will 

submit these verifications and that each 

verification will take approximately 30 

minutes to prepare. 

6. FDA estimates that it will receive 

annually approximately one supplement 

to petitions for stay of agency action as 

described under section 505(q)(1)(I) of 

the act, that approximately one 

respondent will submit this 

supplement, and that each supplement 

will take approximately 6 hours to 

prepare. FDA estimates that it will 

receive annually approximately one 

verification required under section 

505(q)(1)(I) of the act for supplements to 

petitions for stay of agency action, that 

approximately one respondent will 

submit this verification, and that each 

verification will take approximately 30 

minutes to prepare. 

7. FDA estimates that it will receive 

annually approximately one letter from 

petitioners withdrawing a deficient 

petition for stay of agency action that is 

missing the required certification but is 

otherwise within the scope of section 

505(q) of the act. FDA estimates that 

approximately one respondent will 

submit this letter and that the letter will 

take approximately 30 minutes to 

prepare. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Number of 

Respondents 

Annual Frequency 

per Response 

Total annual 

Responses 

Hours per 

Response Total Hours 

Certification for citizen petitions 19 1.32 25 0.5 12.5 

Certification for petitions for stay 

of agency action 3 1 3 0.5 1.5 

Verification for comments to citizen petitions 9 1.33 12 0.5 6.0 

Verification for comments to petitions for stay of agency action 2 1 2 0.5 1.0 

Verification for supplements to 

citizen petitions 7 1.43 10 0.5 5.0 

Supplements to petitions for stay 

of agency action and the 

verification for the supplement 1 1 1 6.5 6.5 

Letter withdrawing a petition for 

stay of agency action 1 1 1 0.5 0.5 

Total Hours 33.0 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

mstockstill on PROD1PC66 with NOTICES

3614 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 

Therefore, the estimated annual 

reporting burden for this information 

collection is 33 hours. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: January 12, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–937 Filed 1–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0224] 

Final Guidance for Sponsors, Industry, 

Researchers, Investigators, and Food 

and Drug Administration Staff: 

Certifications To Accompany Drug, 

Biological Product, and Device 

Applications/Submissions: 

Compliance with Section 402(j) of The 

Public Health Service Act, Added By 

Title VIII of The Food and Drug 

Administration Amendments Act of 

2007; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or agency) is 

announcing the availability of a 

guidance for industry entitled 

‘‘Guidance for Sponsors, Industry, 

Researchers, Investigators, and Food 

and Drug Administration Staff: 

Certifications To Accompany Drug, 

Biological Product, and Device 

Applications/Submissions: Compliance 

with Section 402(j) of The Public Health 

Service Act, Added By Title VIII of The 

Food and Drug Administration 

Amendments Act of 2007’’ dated 

January 2009. The guidance provides 

sponsors, industry, researchers, 

investigators, and FDA staff with the 

agency’s current thinking regarding the 

types of applications and submissions 

that sponsors, industry, researchers, and 

investigators submit to FDA and 

accompanying certifications as 

described in Title VIII of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA). 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Policy, Office of 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, rm. 4305, Silver Spring, 

MD 20993–0002, 301–796–4830. Send 

one self addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, 

rm.1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jarilyn Dupont, Office of Policy, Office 

of Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, rm. 4305, Silver Spring, 

MD 20993–0002, 301–796–4830. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Title VIII of FDAAA, Public Law 110– 

85, amended the Public Health Service 

(PHS) Act by adding new section 402(j), 

42 U.S.C. 282(j). The new provisions 

require that additional information be 

submitted to the clinical trials data bank 

(www.ClinicalTrials.gov) previously 

established by the National Institutes of 

Health (NIH)/National Library of 

Medicine (NLM), including expanded 

information on clinical trials and 

information regarding the results of 

clinical trials. 

The purpose of Title VIII is to provide 

a means for ensuring that the public has 

access to information about certain 

clinical trials. Specifically, Title VIII is 

intended to provide a mechanism for 

the public to learn about clinical trials 

that are being conducted, as well as the 

results of those trials. One provision of 

Title VIII (section 401(j)(5)(B) of the PHS 

Act, 42 U.S.C. 282(j)(5)(B)) requires that 

a certification accompany certain 

human drug, biological product, and 

device applications and submissions to 

FDA. 

The certification required under 

section 402(j)(5)(B) of the PHS Act (42 

U.S.C. 282(j)(5)(B)) plays a role in 

helping to achieve the purposes of Title 

VIII of FDAAA. One purpose of the 

certification is to require the submitter 

to confirm that it has complied with all 

applicable requirements of Title VIII, 

including the requirement to register 

applicable clinical trials. ‘‘Applicable 

clinical trial’’ is defined at section 

402(j)(1)(A)(i) of the PHS Act (42 U.S.C. 

282(j)(1)(A)(i)). For additional 

information on this definition and other 

relevant definitions, visit the NIH Web 

site at http://prsinfo.clinicaltrials.gov. 

Failure to submit a certification, 

knowingly submitting a false 

certification, failure to submit required 

clinical trial information, and 

submission of clinical trial information 

that is false or misleading are all, as 

added by Title VIII of FDAAA, 

prohibited acts under section 301(jj) of 

the Federal Food, Drug, and Cosmetic 

Act (the act). Requiring a certification to 

accompany certain applications and 

submissions submitted to FDA is, 

therefore, one way of encouraging 

compliance with the provisions of the 

law. 

The certification also facilitates FDA’s 

exercise of its responsibilities under the 

law. The certification requirement is 

critical to the agency’s ability to 

determine whether the law has been 

complied with and whether an 

enforcement action is appropriate under 

any of the prohibited acts under section 

301(jj) of the act. Additionally, section 

402(j)(3)(F) of the PHS Act (42 U.S.C. 

282(j)(3)(F)) requires FDA to notify the 

Director of NIH of certain actions taken 

on applications and reports that were 

accompanied by a certification. That 

notification alerts NIH to the fact that 

the responsible party must submit the 

results of the trials within a certain 

period of time, thereby enabling NIH to 

exercise its responsibilities under Title 

VIII. The information provided in the 

certification form also will help FDA 

assist NIH in ‘‘linking’’ information 

posted on FDA’s Web site regarding 

certain FDA regulatory actions to 

specific applicable clinical trials 

included in the registry and results 

databases. This linking, using the 

information in the certification form, 

particularly the NCT (National Clinical 

Trial) number(s) required in the form, 

eventually will allow FDA to help the 

public more easily correlate various 

reports, medical reviews, advisories, 

health alerts, advisory committee 

actions, and other materials with 

specific applicable clinical trials 

registered with ClinicalTrials.gov and 

identified by the NCT number. 

The certification requirement went 

into effect on December 26, 2007. To 

assist sponsors, industry, researchers, 

and investigators in complying with the 

requirement, FDA created a certification 

form, FDA Form 3674, OMB Control No. 

0910–0616, to be used to satisfy the 

certification requirement. Since the 

provision went into effect, FDA has 

received numerous inquiries asking 

whether various kinds of information 

and documents that sponsors, industry, 

researchers, and investigators submit to 

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