11114 Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: OPRE Reports 

Clearance Officer. All requests should 

be identified by the title of the 

information collection. E-mail address: 

OPREinfocollection@acf.hhs.qov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if 0MB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: March 9, 2009. 

Brendan C. Kelly, 

OPRE Reports Clearance Officer. 

[FR Doc. E9–5511 Filed 3–13–09; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0556] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Formal Meetings With 

Sponsors and Applicants for 

Prescription Drug User Fee Act 

Products 

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 April 15, 

2009. 

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 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0429. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

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. 

Guidance for Industry on Formal 

Meetings With Sponsors and 

Applicants for PDUFA Products (OMB 

Control Number 0910–0429)—Extension 

This information collection approval 

request is for an FDA guidance on the 

procedures for formal meetings between 

FDA and sponsors or applicants 

regarding the development and review 

of Prescription Drug User Fee Act 

(PDUFA) products. The guidance 

describes procedures for requesting, 

scheduling, conducting, and 

documenting such formal meetings. The 

guidance provides information on how 

the agency will interpret and apply 

section 119(a) of the Food and Drug 

Administration Modernization Act (the 

Modernization Act), specific PDUFA 

goals for the management of meetings 

associated with the review of human 

drug applications for PDUFA products, 

and provisions of existing regulations 

describing certain meetings (§§ 312.47 

and 312.82 (21 CFR 312.47 and 312.82)). 

The guidance describes two 

collections of information: The 

submission of a meeting request 

containing certain information and the 

submission of an information package in 

advance of the formal meeting. Agency 

regulations at § 312.47(b)(1)(ii), 

(b)(1)(iv), and (b)(2) describe 

information that should be submitted in 

support of a request for an End-of-Phase 

2 meeting and a Pre-New Drug 

Application meeting. The information 

collection provisions under § 312.47 

have been approved by OMB (OMB 

control no. 0910–0014). However, the 

guidance provides additional 

recommendations for submitting 

information to FDA in support of a 

meeting request. As a result, FDA is 

submitting additional estimates for 

OMB approval. 

I. Request for a Meeting 

Under the guidance, a sponsor or 

applicant interested in meeting with the 

Center for Drug Evaluation and Research 

(CDER) or the Center for Biologics 

Evaluation and Research (CBER) should 

submit a meeting request to the 

appropriate FDA component as an 

amendment to the underlying 

application. FDA regulations (§§ 312.23, 

314.50, and 601.2 (21 CFR 312.23, 

314.50, and 601.2)) state that 

information provided to the agency as 

part of an investigational new drug 

application (IND), new drug application 

(NDA), or biological license application 

(BLA) must be submitted with an 

appropriate cover form. Form FDA 1571 

must accompany submissions under 

INDs and Form FDA 356h must 

accompany submissions under NDAs 

and BLAs. Both forms have valid OMB 

control numbers as follows: FDA Form 

1571 (OMB control no. 0910–0014) and 

FDA Form 356h (OMB control no. 

0910–0338). 

In the guidance document, CDER and 

CBER ask that a request for a formal 

meeting be submitted as an amendment 

to the application for the underlying 

product under the requirements of 

§§ 312.23, 314.50, and 601.2; therefore, 

requests should be submitted to the 

agency with the appropriate form 

attached, either Form FDA 1571 or Form 

FDA 356h. The agency recommends that 

a request be submitted in this manner 

for two reasons: (1) To ensure that each 

request is kept in the administrative file 

with the entire underlying application 

and (2) to ensure that pertinent 

information about the request is entered 

into the appropriate tracking databases. 

Use of the information in the agency’s 

tracking databases enables the agency to 

monitor progress on the activities 

attendant to scheduling and holding a 

formal meeting and to ensure that 

appropriate steps will be taken in a 

timely manner. 

Under the guidance, the agency 

requests that sponsors and applicants 

include in meeting requests certain 

information about the proposed meeting 

as follows: 

• Information identifying and 

describing the product; 

• The type of meeting being 

requested; 

• A brief statement of the purpose of 

the meeting; 

• A list of objectives and expected 

outcomes from the meeting; 

• A preliminary proposed agenda; 

• A draft list of questions to be raised 

at the meeting; 

• A list of individuals who will 

represent the sponsor or applicant at the 

meeting; 

Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices 11115 

• A list of agency staff requested to be 

in attendance; 

• The approximate date that the 

information package will be sent to the 

agency; and 

• Suggested dates and times for the 

meeting. 

This information will be used by the 

agency to: (1) Determine the utility of 

the meeting, (2) identify agency staff 

necessary to discuss proposed agenda 

items, and (3) schedule the meeting. 

II. Information Package 

A sponsor or applicant submitting an 

information package to the agency in 

advance of a formal meeting should 

provide summary information relevant 

to the product and supplementary 

information pertaining to any issue 

raised by the sponsor, applicant, or 

agency. The agency recommends that 

information packages generally include: 

• Identifying information about the 

underlying product; 

• A brief statement of the purpose of 

the meeting; 

• A list of objectives and expected 

outcomes of the meeting; 

• A proposed agenda for the meeting; 

• A list of specific questions to be 

addressed at the meeting; 

• A summary of clinical data that will 

be discussed (as appropriate); 

• A summary of preclinical data that 

will be discussed (as appropriate); and 

• Chemistry, manufacturing, and 

controls information that may be 

discussed (as appropriate). 

The purpose of the information 

package is to provide agency staff the 

opportunity to adequately prepare for 

the meeting, including the review of 

relevant data concerning the product. 

Although FDA reviews similar 

information in the meeting request, the 

information package should provide 

updated data that reflect the most 

current and accurate information 

available to the sponsor or applicant. 

The agency finds that reviewing such 

information is critical to achieving a 

productive meeting. 

The collection of information 

described in the guidance reflects the 

current and past practice of sponsors 

and applicants to submit meeting 

requests as amendments to INDs, NDAs, 

and BLAs and to submit background 

information prior to a scheduled 

meeting. Agency regulations currently 

permit such requests and recommend 

the submission of an information 

package before an End of Phase 2 

meeting (§ 312.47(b)(1)(ii) and (b)(1)(iv)) 

and a Pre-NDA meeting (§ 312.47(b)(2)). 

Description of Respondents: A 

sponsor or applicant for a drug or 

biological product who requests a 

formal meeting with the agency 

regarding the development and review 

of a PDUFA product. 

Burden Estimate: An estimate of the 

annual reporting burden for the 

submission of meeting requests and 

information packages under the 

guidance is provided in table 1 of this 

document. 

III. Request for a Formal Meeting 

Based on data collected from the 

review divisions and offices within 

CDER and CBER, FDA estimates that 

approximately 907 sponsors and 

applicants (respondents) request 

approximately 2,210 formal meetings 

with CDER annually and approximately 

144 respondents request approximately 

287 formal meetings with CBER 

annually regarding the development and 

review of a PDUFA product. The hours 

per response, which is the estimated 

number of hours that a respondent 

would spend preparing the information 

to be submitted with a meeting request 

in accordance with the guidance, is 

estimated to be approximately 10 hours. 

Based on FDA’s experience, the agency 

expects it will take respondents this 

amount of time to gather and copy brief 

statements about the product and a 

description of the purpose and details of 

the meeting. 

IV. Information Package 

Based on data collected from the 

review divisions and offices within 

CDER and CBER, FDA estimates that 

approximately 774 respondents 

submitted approximately 1,705 

information packages to CDER annually 

and approximately 120 respondents 

submitted approximately 198 

information packages to CBER annually 

prior to a formal meeting regarding the 

development and review of a PDUFA 

product. The hours per response, which 

is the estimated number of hours that a 

respondent would spend preparing the 

information package in accordance with 

the guidance, is estimated to be 

approximately 18 hours. Based on 

FDA’s experience, the agency expects it 

will take respondents this amount of 

time to gather and copy brief statements 

about the product, a description of the 

details for the anticipated meeting, and 

data and information that generally 

would already have been compiled for 

submission to the agency. 

As stated earlier, the guidance 

provides: (1) Information on how the 

agency will interpret and apply section 

119(a) of the Modernization Act, (2) 

specific PDUFA goals for the 

management of meetings associated 

with the review of human drug 

applications for PDUFA products, and 

(3) provisions of existing regulations 

describing certain meetings (§§ 312.47 

and 312.82). The information collection 

provisions in § 312.47 concerning Endof-Phase 2 meetings and Pre-NDA 

meetings have been approved by OMB 

(OMB control no. 0910–0014). However, 

the guidance provides additional 

recommendations for submitting 

information to FDA in support of a 

meeting request. As a result, FDA is 

submitting these additional estimates 

for OMB approval. 

In the Federal Register of November 

13, 2008 (73 FR 67184), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Meeting Requests and Information 

Packages 

No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Meeting Requests 

CDER 907 2.44 2,210 10 22,100 

CBER 144 1.99 287 10 2,870 

Total 24,970 

Information Packages 

11116 Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Meeting Requests and Information 

Packages 

No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

CDER 774 2.20 1,705 18 30,690 

CBER 120 1.65 198 18 3,564 

Total 34,254 

Grand Total 59,224 

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

Dated: March 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5536 Filed 3–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0635] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Emergency 

Shortages Data Collection System 

(formerly ‘‘Emergency Medical Device 

Shortages Program Survey’’) 

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 April 15, 

2009. 

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 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0491. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

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. 

Emergency Shortages Data Collection 

System (formerly ‘‘Emergency Medical 

Device Shortages Program Survey’’)— 

(Federal Food, Drug, and Cosmetic Act, 

Section 903 (d)(2) (OMB Control 

Number 0910–0491)—Extension 

Under section 903(d)(2) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 393(d)(2)), the FDA 

Commissioner is authorized to 

implement general powers (including 

conducting research) to carry out 

effectively the mission of FDA. 

Subsequent to the events of September 

11, 2001, and as part of broader counterterrorism and emergency preparedness 

activities, FDA’s Center for Devices and 

Radiological Health (CDRH) began 

developing operational plans and 

interventions that would enable the 

Center to anticipate and respond to 

medical device shortages that might 

arise in the context of federally-declared 

disasters/emergencies or regulatory 

actions. In particular, CDRH identified 

the need to acquire and maintain 

detailed data on domestic inventory, 

manufacturing capabilities, distribution 

plans and raw material constraints for 

medical devices that would be in high 

demand, and/or would be vulnerable to 

shortages in specific disaster/emergency 

situations, or following specific 

regulatory actions. Such data could 

support prospective risk assessment, 

help inform risk mitigation strategies, 

and support real-time decision making 

by the Department of Health and Human 

Services during actual emergencies or 

emergency preparedness exercises. 

‘‘The Emergency Medical Device 

Shortage Program Survey’’ was 

developed in 2002 to support the 

acquisition of such data from medical 

device manufacturers. In 2004, CDRH 

changed the process for the data 

collection, and the electronic database 

in which the data were stored and was 

formally renamed the ‘‘Emergency 

Shortages Data Collection System’’ 

(ESDCS). Recognizing that some of the 

data collected may be commercially 

confidential, access to ESDCS is 

restricted to members of the FDA 

Emergency Shortage Team (EST) and 

senior management with a need-toknow. At this time, the need-to-know 

senior management personnel are 

limited to 5 senior managers. Further, 

the data are used by this defined group 

only for decision making and planning 

in the context of a federally-declared 

disaster/emergency, an official 

emergency preparedness exercise, or a 

potential public health risk posed by 

nondisaster-related device shortage. 

The data procurement process 

consists of an initial scripted telephone 

call to a regulatory officer at a registered 

manufacturer of one or more key 

medical devices being tracked in the 

emergency shortages data collection 

system. In this initial call, the intent and 

goals of the data collection effort are 

described, and the specific data request 

is made. After the initial call, one or 

more additional follow-up calls and/or 

electronic mail correspondence may be 

required to verify/validate data sent 

from the manufacturer, confirm receipt 

and/or request additional detail. 

Although the regulatory officer is the 

agent who is initially contacted, they 

may designate an alternate 

representative within their organization 

to correspond subsequently with the 

CDRH EST member who is collecting or 

verifying/validating the data. 

Because of the dynamic nature of the 

medical device industry, particularly 

with respect to specific product lines, 

manufacturing capabilities and raw 

material/subcomponent sourcing, it is 

necessary to update the data in the 

ESDCS at regular intervals. This is done 

on a weekly basis, but efforts are made 

to limit the frequency of outreach to a 

specific manufacturer to no more than 

every 4 months. 

The ESDCS will only include those 

medical devices for which there will 

likely be high demand during a specific