Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices 70599 

Parkway, Cincinnati, Ohio 45226, 

telephone 513/533–8320. 

Reference: 

NIOSH [2006]. Approaches to safe 

nanotechnology: an information 

exchange with NIOSH. Cincinnati, OH: 

Department of Health and Human 

Services, Centers for Disease Control 

and Prevention, National Institute for 

Occupational Safety and Health, July 

2006. Web address for this document: 

http://www.cdc.gov/niosh/topics/ 

nanotech/safenano/. 

Dated: December 5, 2007. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E7–24047 Filed 12–11–07; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0472] 

Agency Emergency Processing Under 

the Office of Management and Budget 

Review; Certification to Accompany 

Drug, Biological Product, and Device 

Applications or Submissions 

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 emergency processing under 

the Paperwork Reduction Act of 1995 

(the PRA). The proposed collection of 

information concerns the certification to 

accompany human drug, biological 

product, and device applications or 

submissions. 

DATES: Fax written comments on the 

collection of information by December 

17, 2007. 

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–NEW and title, 

‘‘Certification to Accompany Drug, 

Biological Product, and Device 

Applications or Submissions.’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. 301–827–

4659. 

SUPPLEMENTARY INFORMATION: FDA has 

requested emergency processing of this 

proposed collection of information 

under section 3507(j) of the PRA (44 

U.S.C. 3507(j) and 5 CFR 1320.13). The 

emergency processing was requested in 

order to comply with the provisions of 

Title VIII of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Public Law 110–85), 

which require this certification to be 

submitted to FDA beginning no later 

than December 26, 2007. This 

information will be needed immediately 

to implement these provisions of 

FDAAA, and it is essential to the 

agency’s mission of protecting and 

promoting the public health. Since the 

statutory deadline for collecting the 

information is December 26, 2007, the 

lack of a form would result in confusion 

for the sponsors/applicants as the 

information necessary for FDA to carry 

out its future statutory responsibilities 

would not be obvious without the form. 

While some sponsors/applicants may 

submit information, it most likely 

would neither be complete nor provided 

in a systematic fashion so that it can be 

more easily retrieved. 

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. 

Certification to Accompany Drug, 

Biological Product, and Device 

Applications or Submissions 

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 with applications 

and submissions currently submitted to 

FDA under part 312 (21 CFR part 312) 

and 21 CFR part 314 (human drugs) 

approved under OMB control numbers 

0910–0014 (expires May 31, 2009) and 

0910–0001 (expires May 31, 2008), 

respectively, part 312 and 21 CFR part 

601 (biological products) approved 

under OMB control numbers 0910–0014 

and 0910–0338 (expires June 30, 2010) 

and 21 CFR parts 807 and 814 (devices) 

approved under OMB control numbers 

0910–0120 (expires August 31, 2010) 

and 0910–0231 (expires November 30, 

2010), respectively. 

Title VIII of FDAAA 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) 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. 354, 

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

of the PHS Act (21 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 

above 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. 

mstockstill on PROD1PC66 with NOTICES

70600 Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices 

Investigational New Drug Applications 

FDA’s Center for Drug Evaluation and 

Research (CDER) received 1,837 

investigational new drug applications 

(INDs) and 24,581 new IND 

amendments in fiscal year (FY) 2004. 

CDER anticipates that IND and 

amendment submission rates will 

remain at or near this level in the near 

future. 

FDA’s Center for Biologics Evaluation 

and Research (CBER) received 227 new 

INDs and 6,689 new IND amendments 

in FY 2004. CBER anticipates that IND 

and amendment submission rates will 

remain at or near this level in the near 

future. 

The estimated total number of 

submissions (new INDs and new 

submissions) subject to mandatory 

certification requirements under section 

402(j)(5)(B) of the PHS Act is 26,418 for 

CDER plus 6,916 for CBER, or 33,334 

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 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 

previously mentioned 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 with NCT numbers prior to 

FDA submission. 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 

CDER and CBER received 214 new 

drug applications (NDA)/biologics 

license applications (BLA)/ 

resubmissions and 8,535 NDA/BLA 

amendments in FY 2004. CDER and 

CBER received 259 efficacy 

supplements/resubmissions to 

previously approved NDAs/BLAs, 2,500 

manufacturing submissions, and 1,273 

labeling submissions in FY 2004. CDER 

and CBER anticipate that new drug/ 

biologic and efficacy supplement 

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 premarket approvals (PMA), 3,635 

510(k) submissions, and 9 humanitarian 

device exemptions (HDE) or 3,695 new 

applications in FY 2004. CDRH received 

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

FY 2004. CDRH received 2,705 PMA/ 

510(k)/HDE supplements in FY 2004. 

CDRH anticipates that application, 

amendment, and supplement rates will 

remain at or near this level in the near 

future. 

The estimated total number of new 

submissions (new marketing 

applications, amendments, and 

supplements) subject to the mandatory 

certification requirements under section 

402(j)(5)(B) of the PHS Act is 12,781 for 

CDER and CBER plus 8,667 for CDRH or 

21,448 new submissions per year. 

The total burden estimate includes all 

submissions for possible inclusion in 

the clinical trials data bank (results). 

The minutes per response is the 

estimated number of hours that a 

respondent would spend preparing the 

information to be submitted to FDA 

under 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, and 510(k)s, 

and consideration of the previously 

mentioned information, FDA estimated 

that approximately 45.0 minutes on 

average would be needed per response 

for certifications which accompany 

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

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. 

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. 

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) 227 ---- .25 57 

CDER (amendment) 24,581 ---- .25 6,145 

CBER (amendment) 6,689 ---- .25 1,672 

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

CDRH (new application) ---- 3,695 .75 2,771 

CDER/CBER (amendment) ---- 8,535 .75 6,401 

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

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

CDER/CBER (manufacturing supplement) ---- 2,500 .75 1,875 

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

CDRH (supplement) ---- 2,705 .75 2,029 

TOTAL 24,419 

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

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices 70601 

We believe the estimate, 24,419 hours 

per year, accurately reflects the burden. 

We recognize that individuals or entities 

less familiar with FDA forms and the 

Clinical Trials Data Bank may require 

greater than 15 and 45 minutes 

(depending on the type of application/ 

submission) per response. 

Dated: December 6, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–6023 Filed 12–7–07; 1:06 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to OMB for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Ryan White HIV/ 

AIDS Program Annual Data Report: 

Data Report Form: (OMB No. 0915–

0253)—Revision 

The Ryan White HIV/AIDS Program 

Annual Data Report, formerly called the 

CARE Act Data Report (CADR), was first 

implemented in 2002 by HRSA’s HIV/ 

AIDS Bureau. It has undergone revisions 

to incorporate the legislative changes 

that occurred in 2006. Grantees and 

their subcontracted service providers 

who are funded under Parts A, B, C, and 

D of Title XXVI of the Public Health 

Service Act, as amended by the Ryan 

White HIV/AIDS Treatment 

Modernization Act of 2006, (Ryan White 

HIV/AIDS Program), fill out the report. 

All Parts of the Ryan White HIV/AIDS 

Program specify HRSA’s responsibilities 

in the administration of grant funds, the 

allocation of funds, the evaluation of 

programs for the population served, and 

the improvement of the quantity and 

quality of care. Accurate records of the 

providers receiving Ryan White HIV/ 

AIDS Program Funding, the services 

provided, and the clients served, 

continue to be critical to the 

implementation of the legislation and 

thus are necessary for HRSA to fulfill its 

responsibilities. Ryan White HIV/AIDS 

Program Grantees are required to report 

aggregate data to HRSA annually. The 

Data Report form is filled out by 

grantees and their subcontracted service 

providers. The report has seven 

different sections containing 

demographic information about the 

service providers, as well as the clients 

served, information about the type of 

core and support services provided, as 

well as the number of clients served, 

information about counseling and 

testing services, clinical information 

about the clients served, demographic 

tables for Parts C and D, and 

information about the Health Insurance 

Program. The primary purposes of the 

Data Report are to: (1) Characterize the 

organizations where clients receive 

services; (2) provide information on the 

number and characteristics of clients 

who receive Ryan White HIV/AIDS 

Program Services; and (3) enable HAB to 

describe the type and amount of 

services a client receives. In addition to 

meeting the goal of accountability to the 

Congress, clients, advocacy groups, and 

the general public, information 

collected on the Data Report is critical 

for HRSA, State, and local grantees, and 

individual providers to assess the status 

of existing HIV-related service delivery 

systems. 

The response burden for grantees is 

estimated as: 

Program under which grantee is funded Number of 

grantees 

Number of 

responses 

# of hours per 

response 

Total hour response burden 

Part A Only ...................................................................................... 56 1 40 2,240 

Part B Only ...................................................................................... 59 1 40 2,360 

Part C Only ...................................................................................... 361 1 20 7,220 

Part D Only ...................................................................................... 90 1 20 1,800 

Subtotal ..................................................................................... 566 ............................ ............................ 13,620 

The response burden for service 

providers is estimated as: 

Program under which grantee is funded Number of 

providers 

Number of 

responses 

# of hours per 

response 

Total hour response burden 

Part A Only ...................................................................................... 792 1 26 20,592 

Part B Only ...................................................................................... 653 1 26 16,978 

Part C Only ...................................................................................... 108 1 44 4,752 

Part D Only ...................................................................................... 75 1 42 3,150 

Funded under more than one program ........................................... 703 1 50 35,150 

Subtotal ..................................................................................... 2,331 ............................ ............................ 80,622 

Total for Both Grantees & Providers ................................. 2,897 ............................ ............................ 94,242 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’

Dated: December 6, 2007. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E7–24022 Filed 12–11–07; 8:45 am] 

BILLING CODE 4165–15–P 

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