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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Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 3615 

the agency must be accompanied by the 

certification. On April 18, 2008, FDA 

published a draft guidance on the 

certification requirement. In the draft 

guidance FDA provided a list of the 

types of submissions and applications 

that typically did not need to be 

accompanied by a certification. We 

received a number of comments to the 

docket concerning whether a 

certification should accompany the 

types of submissions and applications 

listed in the draft guidance, as well as 

other types of documents and 

information submitted to FDA. We also 

received a number of comments on this 

issue during the process for obtaining 

clearance under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520) for the certification form itself. In 

addition, FDA also has had more 

experience with the submission of the 

certification form since the form was 

implemented. 

The comments we received in 

response to the draft guidance and the 

development of the certification form, 

the inquiries to the agency, and our 

evolving experience caused us to 

reconsider our initial approach of 

identifying those documents and 

information that did not need to be 

accompanied by a certification. Instead, 

we concluded that it was more useful to 

identify those applications and 

submissions that must be accompanied 

by a certification. This approach is also 

consistent with many of the comments, 

which asked that we provide more 

specific information than was included 

in the draft guidance. Thus, we intend 

to exercise enforcement discretion 

concerning the submission of a 

certification with certain categories of 

applications and submissions to FDA, as 

noted in the guidance. 

This guidance describes FDA’s 

current thinking, for purposes of 

implementing Title VIII of FDAAA, 

regarding specific types of applications 

and submissions submitted to FDA 

under section 505, 515, 520(m), or 

510(k) of the act, or under section 351 

of the PHS Act, and accompanying 

certifications described in section 

402(j)(5)(B) of the PHS Act, 42 U.S.C. 

282(j)(5)(B). We note that the Agency’s 

discussion of ‘‘applications’’ and 

‘‘submissions’’ in this guidance is not 

necessarily applicable to any other 

provision of law. In determining how to 

interpret the certification requirement, 

FDA has focused on the plain language 

of Title VIII of FDAAA, as well as 

information that Title VIII is intended to 

capture. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking regarding the 

certification requirement in section 

402(j)(5)(B) of the PHS Act (42 U.S.C. 

282(j)(5)(B)). 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 applicable statutes and 

regulations. 

II. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the 

guidance. 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. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

This guidance refers to a previously 

approved collection of information. This 

collection of information is subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information has 

been approved under OMB Control No. 

0910–0616. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance document at 

eitherhttp://www.fda.gov/oc/initiatives/ 

advance/fdaaa.html or http:// 

www.regulations.gov. 

Dated: January 15, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–1183 Filed 1–15–09; 11:15 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0018] 

Report of Quantitative Risk and Benefit 

Assessment of Commercial Fish 

Consumption, Focusing on Fetal 

Neurodevelopmental Effects 

(Measured by Verbal Development in 

Children) and on Coronary Heart 

Disease and Stroke in the General 

Population, and Summary of Published 

Research on the Beneficial Effects of 

Fish Consumption and Omega-3 Fatty 

Acids for Certain Neurodevelopmental 

and Cardiovascular Endpoints; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of two draft documents. The 

first is entitled ‘‘Report of Quantitative 

Risk and Benefit Assessment of 

Commercial Fish Consumption, 

Focusing on Fetal Neurodevelopmental 

Effects (Measured by Verbal 

Development in Children) and on 

Coronary Heart Disease and Stroke in 

the General Population’’ (draft risk and 

benefit assessment report). The draft 

risk and benefit assessment report 

describes an analysis done by FDA that 

results in quantitative estimates of the 

net effect on fetal neurodevelopment in 

children of maternal consumption of 

commercial fish, as measured by verbal 

development and the net effect of eating 

commercial fish on coronary heart 

disease and stroke in the general 

population. Effects with respect to each 

of these health endpoints has been 

associated in the scientific literature 

with methylmercury exposure (which 

primarily occurs through fish 

consumption) and with the 

consumption of fish and of omega-3 

fatty acids, which are found in fish. The 

second draft document entitled 

‘‘Summary of Published Research on the 

Beneficial Effects of Fish Consumption 

and Omega-3 Fatty Acids for Certain 

Neurodevelopmental and 

Cardiovascular Endpoints’’ (draft 

summary of published research) is a 

compendium of research prepared by 

FDA for use in developing its 

quantitative risk and benefit assessment. 

When peer and public review are 

complete, the draft risk and benefit 

assessment report and the draft 

summary of published research are 

intended to add to the growing body of 

scientific literature investigating the 

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