Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20679 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR 314.81(b)(2)(ii)(b) Number of 

respondents 

Number of 

reponses per 

respondent 

Total annual 

respondents 

Average 

burden per 

response 

(in hours) 

Total hours 

The submission of a copy of that portion of each annual 

report containing authorized generic drug information .... 60 6.7 400 3/60 20 

Total .............................................................................. ........................ ........................ ........................ ........................ 520 

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

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8820 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0157] 

Agency Information Collection 

Activities; Proposed Collection; 

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 an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the proposed collection of information 

concerning requests by sponsors of 

investigational new drugs and 

applicants for new drug approvals or 

biologics licenses for fast track 

designation as provided in the guidance 

for industry on fast track drug 

development programs. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 13, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), 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 Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing 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. 

Guidance for Industry: Fast Track Drug 

Development Programs: Designation, 

Development, and Application 

Review—(OMB Control Number 0910– 

0389)—Extension 

Section 112(a) of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) by adding 

section 506 (21 U.S.C. 356). The section 

authorizes FDA to take appropriate 

action to facilitate the development and 

expedite the review of new drugs, 

including biological products, intended 

to treat a serious or life-threatening 

condition and that demonstrate a 

potential to address an unmet medical 

need. Under section 112(b) of FDAMA, 

FDA issued guidance to industry on fast 

track policies and procedures outlined 

in section 506 of the FD&C Act. The 

guidance discusses collections of 

information that are specified under 

section 506 of the FD&C Act, other 

sections of the Public Health Service 

Act (the PHS Act), or implementing 

regulations. The guidance describes 

three general areas involving collection 

of information: (1) Fast track 

designation requests; (2) premeeting 

packages; and (3) requests to submit 

portions of an application. Of these, fast 

track designation requests and 

premeeting packages, in support of 

receiving a fast track program benefit, 

provide for additional collections of 

information not covered elsewhere in 

statute or regulation. Information in 

support of fast track designation or fast 

track program benefits that has 

previously been submitted to the 

Agency, may, in some cases, be 

incorporated into the request by 

referring to the information rather than 

resubmitting it. 

Under section 506(a)(1) of the FD&C 

Act, an applicant who seeks fast track 

designation is required to submit a 

request to the Agency showing that the 

product: (1) Is intended for a serious or 

life-threatening condition and (2) has 

the potential to address an unmet 

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20680 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

medical need. Mostly, the Agency 

expects that information to support a 

designation request will have been 

gathered under existing provisions of 

the FD&C Act, the PHS Act, or the 

implementing regulations. If such 

information has already been submitted 

to the Agency, the information may be 

summarized in the fast track designation 

request. The guidance recommends that 

a designation request include, where 

applicable, additional information not 

specified elsewhere by statute or 

regulation. For example, additional 

information may be needed to show that 

a product has the potential to address an 

unmet medical need where an approved 

therapy exists for the serious or lifethreatening condition to be treated. 

Such information may include clinical 

data, published reports, summaries of 

data and reports, and a list of references. 

The amount of information and 

discussion in a designation request need 

not be voluminous, but it should be 

sufficient to permit a reviewer to assess 

whether the criteria for fast track 

designation have been met. 

After the Agency makes a fast track 

designation, a sponsor or applicant may 

submit a premeeting package which 

may include additional information 

supporting a request to participate in 

certain fast track programs. The 

premeeting package serves as 

background information for the meeting 

and should support the intended 

objectives of the meeting. As with the 

request for fast track designation, the 

Agency expects that most sponsors or 

applicants will have gathered such 

information to meet existing 

requirements under the FD&C Act, the 

PHS Act, or implementing regulations. 

These may include descriptions of 

clinical safety and efficacy trials not 

conducted under an investigational new 

drug application (IND) (i.e., foreign 

studies), and information to support a 

request for accelerated approval. If such 

information has already been submitted 

to FDA, the information may be 

summarized in the premeeting package. 

Consequently, FDA anticipates that the 

additional collection of information 

attributed solely to the guidance will be 

minimal. 

Under section 506(c) of the FD&C Act, 

a sponsor must submit sufficient 

clinical data for the Agency to 

determine, after preliminary evaluation, 

that a fast track product may be 

effective. Section 506(c) also requires 

that an applicant provide a schedule for 

the submission of information necessary 

to make the application complete before 

FDA can commence its review. The 

guidance does not provide for any new 

collection of information regarding the 

submission of portions of an application 

that are not required under section 

506(c) of the FD&C Act or any other 

provision of the FD&C Act. All forms 

referred to in the guidance have a 

current OMB approval: FDA Forms 1571 

(OMB control number 0910–0014); 356h 

(OMB control number 0910–0338); and 

3397 (OMB control number 0910–0297). 

Respondents to this information 

collection are sponsors and applicants 

who seek fast track designation under 

section 506 of the FD&C Act. The 

Agency estimates the total annual 

number of respondents submitting 

requests for fast track designation to the 

Center for Biologics Evaluation and 

Research and the Center for Drug 

Evaluation and Research is 

approximately 97, and the number of 

requests received is approximately 118 

annually. FDA estimates that the 

number of hours needed to prepare a 

request for fast track designation is 

approximately 60 hours per request. 

Not all requests for fast track 

designation may meet the statutory 

standard. Of the requests for fast track 

designation made per year, the Agency 

granted 77 from 64 respondents, and for 

each of these granted requests a 

premeeting package was submitted to 

the Agency. FDA estimates that the 

preparation hours are approximately 

100 hours per premeeting package. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Reporting activity Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours 

per response Total hours 

Designation Request ............................................................ 97 1.22 118 60 7,080 

Premeeting Packages .......................................................... 64 1.20 77 100 7,700 

Total .............................................................................. 14,780 

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

Dated: April 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8818 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0627] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Application for 

Food and Drug Administration 

Approval To Market a New Drug 

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 May 13, 

2011. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0001. Also 

include the FDA docket number found 

mstockstill on DSKH9S0YB1PROD with NOTICES