50024 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 

to periodically assess the grantees’

progress on achieving certain outcomes. 

The legislation mandated that these 

performance indicators be developed 

through a consultative process involving 

ACE, the Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), and representatives of the 

State or Tribal agencies who are 

members of the regional partnerships. 

The final set of RPG performance 

indicators was approved by ACF and 

disseminated to the funded grantees in 

January 2008. It includes a total of 23 

indicators across four outcome domains: 

child/youth (9 indicators), adult (7 

indicators), family/relationship (5 

indicators), and regional partnership/ 

service capacity (2 indicators). It also 

includes a core set of child and adult 

demographic elements that will provide 

important context needed to properly 

analyze, explain and understand the 

outcomes. No other national data 

collection measures these critical child, 

adult, family, and RPG outcomes 

specifically for these children and 

families. The data also will have 

significant implications for policy and 

program development for child wellbeing programs nationwide. 

The purpose of this request is to 

obtain OMB approval to collect this 

legislatively required performance and 

outcome data from the RPGs. 

To minimize grantee data collection 

and reporting burden, many of the data 

elements are already being collected by 

counties and States in order to report 

Federally-mandated data for the 

Adoption and Foster Care Analysis and 

Reporting System (AFCARS), the 

Treatment Episode Data Set (TEDS) and 

the National Outcome Measures 

(NOMs); in addition, all States 

voluntarily submit data for the Federal 

National Child Abuse and Neglect Data 

System (NCANDS). Therefore, most 

child welfare data elements included in 

the RPG performance measures can be 

found in a State’s automated case 

management system, which is often a 

Federally-funded Statewide Automated 

Child Welfare Information System 

(SACWIS) TEDS admission and 

discharge data are collected by State 

substance abuse agencies according to 

their own information systems for 

monitoring substance abuse treatment 

admissions and transmitted monthly or 

quarterly to the SAMHSA contractor. 

In short, as a result of prior Federal 

government reporting requirements, 

States are already collecting several data 

elements needed by the RPGs. The RPGs 

can download information from these 

existing State child welfare and 

substance abuse treatment data systems 

to obtain data to monitor their RPG 

program outcomes, thereby reducing the 

amount of primary data collection 

needed. 

Beginning in year two, grantees will 

submit a data file with their required 

indicator data, according to their final 

set of indicators, every six months. 

Respondents: RPG Grantees. 

ANNUAL BURDEN ESTIMATES

Information collection Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Private Sector .................................................................................................. 22 2 175.5 7,722 

State, Local, or Tribal Governments ................................................................ 31 2 175.5 10,881 

Estimated Total Annual Burden 

Hours: 18,603 

Additional Information: ACE is 

requesting that OMB grant a 90 day 

approval for this information collection 

under procedures for emergency 

processing by September 30, 2008. A 

copy of this information collection, with 

applicable supporting documentation, 

may be obtained by calling the 

Administration for Children and 

Families, Reports Clearance Officer, 

Robert Sargis at (202) 690–7275. 

Comments and questions about the 

information collection described above 

should be directed to the Office of 

Information and Regulatory Affairs, 

Attn: OMB Desk Officer for ACE, Office 

of Management and Budget, Paperwork 

Reduction Project, 725 17th Street, NW., 

Washington, DC 20503, (202) 395–7316. 

Dated: August 18, 2008. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. E8–19443 Filed 8–22–08; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0144] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Certification to 

Accompany Drug, Biological Product, 

and Device Applications or 

Submissions (Form FDA 3674) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

24, 2008. 

ADDRESSES: 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: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0616. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Certification to Accompany Drug, 

Biological Product, and Device 

Applications or Submissions (Form 

FDA 3674) (OMB Control Number 

0910–0616) — Extension 

The information required under 

section 402(j)(5)(B) of the Public Health 

Service Act (PHS Act) (42 U.S.C. 

282(j)(5)(B)) will be submitted in the 

form of a certification to accompany 

applications and submissions currently 

submitted to FDA under part 312 (21 


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Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 50025 

1FDA has verified the Web site address, but FDA 

is not responsible for any subsequent changes to the 

Web site after this document publishes in the 

Federal Register. 

CFR part 312) and 21 CFR part 314 

(human drugs) and approved under 

OMB control numbers 0910–0014 

(expires May 31, 2009) and 0910–0001 

(expires May 31, 2011), respectively; 

submitted to FDA under part 312 and 21 

CFR part 601 (biological products) and 

approved under OMB control numbers 

0910–0014 and 0910–0338 (expires June 

30, 2010); and submitted to FDA under 

21 CFR parts 807 and 814 (devices) and 

approved under OMB control numbers 

0910–0120 (expires August 31, 2010) 

and 0910–0231 (expires November 30, 

2010), respectively. 

Title VIII of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Public Law 110–85) 

amended the PHS Act by adding section 

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

provisions require additional 

information to be submitted to the 

clinical trials data bank 

(ClinicalTrials.gov)1 previously 

established by the National Institutes of 

Health/National Library of Medicine, 

including expanded information on 

clinical trials and information on the 

results of clinical trials. The provisions 

include new responsibilities for FDA as 

well as several amendments to the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). 

One new provision, section 

402(j)(5)(B) of the PHS Act, requires that 

a certification accompany human drug, 

biological, and device product 

submissions made to FDA. Specifically, 

at the time of submission of an 

application under sections 505, 515, or 

520(m) of the FD&C Act (21 U.S.C. 355, 

360e, or 360j(m)), or under section 351 

of the PHS Act (42 U.S.C. 262), or 

submission of a report under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)), such application or submission 

must be accompanied by a certification 

that all applicable requirements of 

section 402(j) of the PHS Act have been 

met. Where available, such certification 

must include the appropriate National 

Clinical Trial (NCT) numbers. 

The proposed collection of 

information is necessary to satisfy the 

previously mentioned statutory 

requirement. 

The importance of obtaining these 

data relates to adherence to the legal 

requirements for submissions to the 

clinical trials registry and results data 

bank and ensuring that individuals and 

organizations submitting applications or 

reports to FDA under the listed 

provisions of the FD&C Act or the PHS 

Act adhere to the appropriate legal and 

regulatory requirements for certifying to 

having complied with those 

requirements. The failure to submit the 

certification required by section 

402(j)(5)(B) of the PHS Act, and the 

knowing submission of a false 

certification are both prohibited acts 

under section 301 of the FD&C Act (21 

U.S.C. 331). Violations are subject to 

civil money penalties. 

Investigational New Drug Applications 

FDA’s Center for Drug Evaluation and 

Research (CDER) received 1,837 

investigational new drug applications 

(INDs) and 20,969 new IND 

amendments in Fiscal Year (FY) 2004. 

CDER received 4,764 annual reports in 

FY 2004. CDER anticipates that IND, 

amendment, and annual report 

submission rates will remain at or near 

this level in the near future. 

FDA’s Center for Biologics Evaluation 

and Research (CBER) received 206 new 

INDs and 826 new IND amendments in 

FY 2004. CBER received 878 annual 

reports in FY 2004. CBER anticipates 

that IND, amendment, and annual report 

submission rates will remain at or near 

this level in the near future. 

The estimated total number of 

submissions (new INDs, new 

submissions, and annual reports) 

subject to mandatory certification 

requirements under 42 U.S.C. 

282(j)(5)(B), section 402(j)(5)(B) of the 

PHS Act, is 27,570 for CDER plus 1,910 

for CBER, or 29,480 submissions per 

year. The minutes per response is the 

estimated number of minutes that a 

respondent would spend preparing the 

information to be submitted to FDA 

under 42 U.S.C. 282(j)(5)(B), section 

402(j)(5)(B) of the PHS Act, including 

the time it takes to type the necessary 

information. 

Based on its experience reviewing 

INDs and consideration of the previous 

information, FDA estimated that 

approximately 15.0 minutes on average 

would be needed per response for 

certifications which accompany IND 

applications and submissions. It is 

assumed that most submissions to 

investigational applications will 

reference only a few protocols for which 

the sponsor/applicant/submitter has 

obtained a National Clinical Trial (NCT) 

number from ClinicalTrials.gov prior to 

making the submission to FDA. It is also 

assumed that the sponsor/applicant/ 

submitter has electronic capabilities 

allowing them to retrieve the 

information necessary to complete the 

form in an efficient manner. 

Marketing Applications/Submissions 

In 2004, CDER and CBER received 214 

new drug applications (NDA)/biologics 

license applications (BLA)/ 

resubmissions and 4,451 NDA/BLA 

amendments for which certifications are 

needed. CDER and CBER received 259 

efficacy supplements/resubmissions to 

previously approved NDAs/BLAs, and 

1,273 labeling submissions in FY 2004. 

CDER received 7,753 annual reports and 

CBER received 629 annual reports in FY 

2004. CDER and CBER anticipate that 

new drug/biologic, efficacy supplement, 

and annual report submission rates will 

remain at or near this level in the near 

future. 

FDA’s Center for Devices and 

Radiological Health (CDRH) received 51 

new applications for premarket 

approvals (PMA), 364 510(k) 

submissions containing clinical 

information, and 9 applications for 

humanitarian device exemptions (HDE), 

for a total of 424 new applications/ 

submissions in FY 2004. CDRH received 

2,267 PMA/510(k)/HDE amendments in 

FY 2004. CDRH received 2,526 PMA/ 

510(k)/HDE supplements in FY 2004. 

CDRH received 433 annual reports in 

FY 2004. CDRH anticipates that 

application, amendment, supplement, 

and annual report submission rates will 

remain at or near this level in the near 

future. 

FDA’s Office of Generic Drugs (OGD) 

received 563 abbreviated new drug 

applications (ANDAs) in FY 2004. OGD 

received 477 bioequivalence 

amendments/supplements and 723 

labeling supplements in FY 2004. OGD 

received 5,173 annual reports in FY 

2004. OGD anticipates that application, 

amendment, supplement, and annual 

report submission rates will remain at or 

near this level in the near future. 

The estimated total number of new 

submissions (new marketing 

applications/submissions, amendments, 

supplements, and annual reports) 

subject to the mandatory certification 

requirements under 42 U.S.C. 

282(j)(5)(B), section 402(j)(5)(B) of the 

PHS Act, is 14,579 for CDER and CBER, 

5,650 for CDRH, plus 6,936 for OGD or 

27,165 new submissions per year. The 

minutes per response is the estimated 

number of minutes that a respondent 

would spend preparing the information 

to be submitted to FDA under 42 U.S.C. 

282(j)(5)(B), section 402(j)(5)(B) of the 

PHS Act, including the time it takes to 

type the necessary information and 

compile a list of relevant NCT numbers. 

Based on its experience reviewing 

NDAs, BLAs, PMAs, HDEs, 510(k)s, and 

ANDAs and consideration of the 

previous information, FDA estimated 


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50026 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 

that approximately 45.0 minutes on 

average would be needed per response 

for certifications which accompany 

NDA, BLA, PMA, HDE, 510(k), and 

ANDA applications and submissions. It 

is assumed that the sponsor/applicant/ 

submitter has electronic capabilities 

allowing them to retrieve the 

information necessary to complete the 

form in an efficient manner. 

In the Federal Register of March 5, 

2008 (73 FR 11926), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. FDA received a number of 

comments concerning such issues as 

FDA’s legal interpretation of the 

statutory language, clarification of the 

instructions to the form, concerns with 

FDA’s estimates of the amount of time 

required to fill out the form, and 

suggestions for technical formatting 

changes to the form. 

(Comment 1) A number of 

respondents maintained that, because 

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

not apply to INDs submitted to FDA 

under section 505(i) of the FD&C Act, a 

certification form need not accompany 

INDs submitted to FDA. As previously 

stated, section 402(j)(5)(B) of the PHS 

Act, requires that, at the time of 

submission of an application under 

sections 505, 515, or 520(m) of the 

FD&C Act (21 U.S.C. 355, 360e, or 

360j(m)), or under section 351 of the 

PHS Act (42 U.S.C. 262), or submission 

of a report under section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)), such 

application or submission must be 

accompanied by a certification that all 

applicable requirements of section 

402(j) of the PHS Act have been met. 

The comments challenge the agency’s 

interpretation of Section 402(j)(5)(B) of 

the PHS Act on several fronts. The 

respondents maintain that IND 

submissions are not ‘‘applications’’ in 

the terminology of the FD&C Act. Some 

comments rely upon language found in 

HR 2900, an earlier version of the 

legislation that was eventually enacted 

as FDAAA, to support their assertion 

that Congress both understood the 

distinction between ‘‘applications’’ on 

the one hand, and ‘‘submissions’’ and 

‘‘exemptions’’ on the other, and that 

Congress explicitly omitted exemptions 

from the scope of the certification 

requirement. The language in HR 2900 

would have required the FDA to verify 

that the requirements of section 402(j) 

were met for each applicable clinical 

trial submitted when considering a drug 

for an exemption under section 505(i). 

Section 402(j) no longer includes this 

verification requirement, and the 

explicit reference to section 505(i) in HR 

2900 was omitted from section 

402(j)(5)(B) of the PHS Act. Commenters 

further stated that submitting a 

certification of compliance when 

submitting an IND is illogical because 

an IND must be submitted to FDA prior 

to enrolling subjects in the clinical 

trials, yet registration in the clinical 

trials data bank is not generally required 

until 21 days after the first subject is 

enrolled in the clinical trial. In addition, 

some of the comments noted that the 

conforming amendment to section 505(i) 

of the FD&C Act relates only to 

informed consent documentation and 

includes no reference to the certification 

requirement. 

(Response) FDA does not agree with 

these conclusions. FDA agrees that the 

word ‘‘application’’ is not used in 

section 505(i) of the FD&C Act in 

reference to an IND. However, section 

505(i)(1) directed the Secretary of 

Health and Human Services to issue 

regulations exempting from the 

requirements of section 505 of the FD&C 

Act drugs intended solely for 

investigational use. The regulations 

issued by FDA under this authority 

define an IND as ‘‘an investigational 

new drug application.’’ 21 CFR 312.3 

(emphasis added). Furthermore, these 

regulations repeatedly use the term 

‘‘application’’ in reference to an IND. 

Therefore, FDA considers an IND to be 

an application under section 505 of the 

FD&C Act . Congress is familiar with 

FDA regulations and could have 

specifically exempted INDs from the 

certification process by directly 

excluding 505(i) from the scope of 

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

FDA disagrees with the commenters’

conclusions that the precursor language 

in HR 2900 demonstrates that Congress 

intended to exclude INDs from the 

certification requirement and that 

Congress understood the difference 

between marketing applications and 

IND submissions and exemptions. FDA 

has concluded that the reference to 

section 505 of the FD&C Act was simply 

a streamlined reference to all 

applications and submissions possible 

under section 505 of the FD&C Act. The 

scope of Title VIII of FDAAA, the 

numerous requirements for updating the 

clinical trials registry information, the 

inclusion of a new clinical trials results 

data bank, and the new enforcement 

provisions (including making failure to 

file a certification a prohibited act) 

indicate that Congress intended that the 

clinical trials data bank include 

information about clinical trials 

throughout the product development 

life cycle. Clearly, the IND phase is an 

extremely important phase of this 

process. The certification required by 

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

one means of ensuring that the clinical 

trial registry information is submitted 

when required. This information is 

required to be submitted to the registry 

data bank well before an NDA is ever 

filed with FDA. If the certification did 

not accompany INDs, there would be no 

means of ensuring that information is 

submitted to the registry data bank 

during the investigational stage, which 

would be inconsistent with the statute’s 

intent to have such information 

available. 

Further, submission of the 

certification with INDs helps to ensure 

that the clinical trial information is 

submitted to the registry data bank for 

trials that are never submitted in an 

NDA or a BLA. Many trials are never 

submitted in an NDA or a BLA. 

Requiring that the certification 

accompany INDs helps ensure that 

applicable clinical trials that are not 

included in an NDA or BLA are 

registered as required. The fact that an 

original IND application is filed with 

FDA before the responsible party is 

required to register a trial does not 

require the conclusion that certifications 

were intended to be inapplicable to 

INDs. Throughout the life of an IND, 

there are numerous opportunities for 

filing IND amendments, many of which 

will be filed after the trial is required to 

be registered. Submission of the 

certification with these IND 

amendments helps to ensure that the 

requirements of section 402(j) of the 

PHS Act are met. 

The lack of a conforming amendment 

for INDs is not an indicator that 

certifications are not required to be 

submitted with INDs. There is also no 

conforming amendment for BLAs, but it 

is clear from the wording of section 

402(j)(5)(B) of the PHS Act that the 

certification is required to be submitted 

with applications under section 351 of 

the PHS Act. The statute must be 

considered in its entirety; in light of the 

other provisions of the statute discussed 

in the previous paragraph, and the 

language of section 402(j)(5)(B), FDA 

has concluded that the absence of those 

two conforming amendments does not 

detract from the statutory language 

requiring submission of a certification 

when submitting an application under 

section 505 of the FD&C Act (or when 

submitting a BLA under section 351 of 

the PHS Act). Accordingly, FDA 

concludes that the certification form 

should accompany INDs. 

(Comment 2) A number of comments 

challenged FDA’s conclusion that the 

term ‘‘application’’ refers to 

supplements, annual reports, or adverse 

event reports. 


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Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 50027 

(Response) The term ‘‘application’’ is 

used in the context of many filings 

made with FDA, particularly with 

products handled by CDER and CBER. 

Supplements, annual reports, and other 

submissions are all characterized as 

‘‘applications’’ by FDA and are 

identified as such throughout parts 312 

and 314 of FDA’s regulations. For 

example, the form with which sponsors 

submit most IND, NDA, and BLArelated submissions is the Form FDA 

356h, which is titled ‘‘Application to 

Market a New Drug, Biologic, or an 

Antibiotic Drug for Human Use,’’

includes check boxes for submitting, 

among other things, annual reports, 

efficacy supplement, labeling 

supplement and chemistry 

manufacturing and controls 

supplement. As stated previously, FDA 

assumes that Congress was familiar with 

FDA regulations when it drafted section 

402(j) of the PHS Act. 

FDA appreciates that there are many 

routine filings that fall under this 

broader definition of application; 

however, the relevant statutory language 

is itself written very broadly. FDA 

recognizes the burden associated with 

submitting certifications with all of 

these filings, and FDA continues to 

work to identify filings which may not 

need to be accompanied by a 

certification. In April 2008, FDA issued 

a draft guidance describing FDA’s 

current thinking on the types of 

information and documents that need 

not be accompanied by a certification. 

(See, 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, April 2008, 

available at http://www.fda.gov/oc/ 

initiatives/fdaaa/ 

guidancelcertifications.html). 

FDA will address any suggestions 

made by the respondents that are 

relevant to the issues contained in the 

draft guidance when FDA finalizes that 

draft guidance. 

(Comment 3) A number of comments 

concerned the burden estimate and 

stated that FDA underestimated the 

amount of time needed to prepare the 

form. Related to these comments were 

comments that requested the form be 

PDF fillable; that it be able to be 

electronically saved in order to be used 

repeatedly; and/or that the form be 

combined with other existing forms. 

(Response) In evaluating the burden, 

FDA considered the fact that multiple 

certifications relating to a single IND or 

NDA may be filed with FDA. FDA 

anticipated that many submitters would 

pre-fill and save electronic versions of 

the forms necessary for existing 

applications. When an NCT number 

becomes available or a new one is 

issued related to a particular 

application, it then can simply be added 

to the previously completed form. 

Although the draft certification form 

was not PDF fillable and was not able 

to be saved electronically, the form 

currently is PDF fillable and is able to 

be saved electronically, which means it 

can be amended by submitters as 

necessary. FDA further determined that, 

over time, familiarity with the form and 

the requirements of section 402(j) of the 

PHS Act would significantly reduce the 

amount of time needed to prepare the 

form for filing. 

With regard to the suggestion that the 

certification be incorporated into 

existing forms, section 402(j)(5) of the 

PHS Act requires that the certification 

‘‘accompany’’ an application or 

submission, and we infer from this 

wording that the certification is not 

intended to be part of that application 

or submission. Because the existing 

forms are considered to be part of the 

application or submission, it is not 

appropriate to add the certification to 

those forms. FDA notes, however, that it 

is possible that, as FDA’s information 

technology systems continue to evolve, 

more forms and submissions will be 

filed electronically, and there will be a 

means to transfer information from an 

application onto the certification form. 

(Comment 4) One comment requested 

that the form be modified to remove the 

second sentence above the signature 

block. The second sentence currently 

reads: ‘‘Warning: A willfully and 

knowingly false statement is a criminal 

offense, U.S. Code, title 18, section 

1001.’’ The rationale for requesting 

removal of the sentence was that 

‘‘FDAAA does not authorize FDA to 

bring a perjury action for failure to 

certify accurately.’’

(Response) The sentence requested to 

be removed does not entail a perjury 

charge. In the draft certification form 

circulated for comment in December 

2007, FDA did include a sentence that 

indicated a charge of perjury could be 

brought. After further consideration of 

the statute and the certification form, 

FDA concluded that this sentence 

should be removed. However, the 

knowing and willful inclusion of a 

materially false statement in any 

government document is subject to 18 

U.S.C. 1001, which allows a criminal 

charge to be brought for violations of 

that section. Accordingly, this reference 

to 18 U.S.C. 1001 will not be removed 

from the form. 

(Comment 5) A number of 

respondents commented that the 

certification should apply only to 

clinical trials sponsored by the 

applicant and the form should not 

require certification with regard to trials 

over which the manufacturer/sponsor 

had no control. 

(Response) The certification 

provision, section 402(j)(5)(B) of the 

PHS Act, does not make a distinction 

between trials conducted by the sponsor 

and trials relied upon in the application 

but conducted by entities other than the 

sponsor. FDA is aware that sponsors or 

applicants will be required to certify as 

to trials they did not conduct or register 

in the clinical trials data bank. FDA has 

addressed this concern by requiring the 

submitter to declare that the information 

submitted is accurate, true, and 

complete ‘‘to the best of her/his 

knowledge.’’

(Comment 6) Respondents made a 

number of miscellaneous suggestions 

related to the certification form such as 

changing the FDA Form 3674 to 

eliminate sections 9.A and 9.B.; 

clarifying the certification form’s 

instructions; and updating the eCTD 

(electronic common technical 

document) specifications to account for 

the certification form. 

(Response) At the current time, the 

form will remain the same. The boxes 

9.A and 9.B in the certification form 

will not be removed. These boxes 

provide information allowing FDA to 

determine if there are clinical trials 

referenced in the application 

/submission to which the requirements 

of section 402(j) of the PHS Act apply 

without having to review each clinical 

trial included in the application or 

submission. However, we have updated 

the instructions to provide additional 

clarity for sponsors in filling out the 

information required. Lastly, as the 

eCTD specifications are updated, FDA 

intends to consider adding an 

appropriate leaf module for the 

certification form. 

Estimated Annual Reporting Burden 

Table 1 of this document provides an 

estimate of the annual reporting burden 

for the submission of information to 

satisfy the requirements of section 

402(j)(5)(B) of the PHS Act. The annual 

reporting burden reflects changes made 

based on certain applications/ 

submissions either removed from the 

burden calculations made in the original 

estimates or new applications/ 

submissions added to the burden 

calculations. Those applications/ 

submissions removed include those we 

currently have determined do not 


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50028 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 

typically require that a certification 

form accompany the application/ 

submission, as described in our April 

2008 Draft Guidance. Added to the 

burden were generic applications/ 

submissions, which were originally not 

included in the burden calculations, but 

have since been determined to require a 

certification form accompany the 

application/submission. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Investigational 

Applications 

Marketing 

Applications 

Hours per 

Response Total Hours 

CDER (new application) 1,837 ---- .25 459 

CBER (new application) 206 ---- .25 52 

CDER (amendment) 20,969 ---- .25 5,242 

CBER (amendment) 826 ---- .25 207 

CDER (annual report) 4,764 .25 1,191 

CBER (annual report) 878 .25 220 

CDER/CBER (new application/resubmission) ---- 214 .75 161 

CDRH (new application) ---- 424 .75 318 

CDER/CBER (amendment) ---- 4,451 .75 3,338 

CDRH (amendment) ---- 2,267 .75 1,700 

CDER/CBER (efficacy supplement/resubmission) ---- 259 .75 194 

CDER (annual report) ---- 7,753 .75 5,815 

CBER (annual report) ---- 629 .75 472 

CDER/CBER (labeling supplement) ---- 1,273 .75 955 

CDRH (supplement) ---- 2,526 .75 1,895 

CDRH (annual report) 433 .75 325 

OGD (original) 563 .75 422 

OGD ( BE amendment/supplement) 477 .75 358 

OGD (labeling supplement) 723 .75 542 

OGD (annual report) 5,173 .75 3,880 

TOTAL 27,746 

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

We believe the estimate of 27,746 

hours per year accurately reflects the 

burden. We recognize that individuals 

or entities less familiar with FDA forms 

and the clinical trials data bank 

(ClinicalTrials.gov) may require greater 

than 15 and 45 minutes (depending on 

the type of application/submission) per 

response. 

Dated: August 19, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19625 Filed 8–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0259] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry: Fast Track Drug 

Development Programs: Designation, 

Development, and Application Review 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

24, 2008. 

ADDRESSES: 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: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0389. Also 

include the FDA docket number found 


ebenthall on PRODPC60 with NOTICES