17962 Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices 

CY 2011 ANNUAL REPORTING BURDEN—Continued 

Data 

collection 

activity 

Number 

of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average 

hours per 

response 

Total 

hour 

burden 

12 months .................................................................. 879 1 879 0.92 809 

Sub Total ............................................................ 3,957 .......................... 3,957 .......................... 3,487 

Record Management by FY2008 and anticipated FY2009 and FY2010 Grantee Staff 

Events Tracking ......................................................... 18 800 14,400 0.03 432 

Person Tracking ......................................................... 18 80 1,440 0.1 94 

Service Use ................................................................ 18 50 900 0.17 153 

Arrest History ............................................................. 18 50 900 0.17 153 

Sub Total ............................................................ 72 .......................... 17,640 .......................... 832 

FY2008 and FY2009 Grantees 

Interview and Tracking data submission ................... 18 12 48 0.17 8 

Overall Total ....................................................... 4047 .......................... 21,645 .......................... 4,327 

CY 2012 ANNUAL REPORTING BURDEN

Data 

collection 

activity 

Number 

of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average 

hours per 

response 

Total 

hour 

burden 

Client Interviews for anticipated FY2009 and 2010: Revised Instrument 

Baseline (at enrollment) ............................................. 1,200 1 1,200 0.83 996 

6 months .................................................................... 1,080 1 1,080 0.92 994 

12 months .................................................................. 1,084 1 1,084 0.92 998 

Sub Total ............................................................ 3,364 .......................... 3,364 .......................... 2,987 

Record Management by anticipated FY2009 and FY2010 Grantee Staff 

Events Tracking ......................................................... 12 800 9,600 0.03 288 

Person Tracking ......................................................... 12 70 840 0.1 55 

Service Use ................................................................ 12 25 300 0.17 51 

Arrest History ............................................................. 12 25 300 0.17 51 

Sub Total ............................................................ 48 .......................... 11,040 .......................... 445 

FY2008 and FY2009 Grantees 

Interview and Tracking data submission ................... 18 12 48 0.17 8 

Overall Total ....................................................... 3,424 .......................... 14,452 .......................... 3,440 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: April 13, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–8984 Filed 4–17–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0163] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Draft Guidance, 

Emergency Use Authorization of 

Medical Products 

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 extension of the collection 

of information related to emergency use 

authorizations (EUAs) by the agency. 

DATES: Submit written or electronic 

comments on the collection of 

information by June 19, 2009. 


rmajette on PRODPC74 with NOTICES
Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices 17963 

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: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

Reporting and Recordkeeping for 

Emergency Use Authorization of 

Medical Products (OMB Control 

Number 0910–0595—Extension) 

The draft guidance describes the 

agency’s general recommendations and 

procedures for issuance of EUAs under 

section 564 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

360bbb–3), which was amended by the 

Project BioShield Act of 2004 (Public 

Law 108–276). The act permits the FDA 

Commissioner (the Commissioner) to 

authorize the use of unapproved 

medical products or unapproved uses of 

approved medical products during an 

emergency declared under section 564 

of the act. The data to support issuance 

of an EUA must demonstrate that, based 

on the totality of the scientific evidence 

available to the Commissioner, 

including data from adequate and wellcontrolled clinical trials (if available), it 

is reasonable to believe that the product 

may be effective in diagnosing, treating, 

or preventing a serious or lifethreatening disease or condition (21 

U.S.C. 360bbb–3(c)). Although the exact 

type and amount of data needed to 

support an EUA may vary depending on 

the nature of the declared emergency 

and the nature of the candidate product, 

FDA recommends that a request for 

consideration for an EUA include 

scientific evidence evaluating the 

product’s safety and effectiveness, 

including the adverse event profile for 

diagnosis, treatment, or prevention of 

the serious or life-threatening disease or 

condition, as well as data and other 

information on safety, effectiveness, 

risks and benefits, and (to the extent 

available) alternatives. 

Under section 564 of the act, the 

Commissioner may establish conditions 

on the approval of an EUA. Section 

564(e) of the act requires the 

Commissioner (to the extent practicable 

given the circumstances of the 

emergency) to establish certain 

conditions on an authorization that the 

Commissioner finds necessary or 

appropriate to protect the public health 

and permits the Commissioner to 

establish other conditions that he finds 

necessary or appropriate to protect the 

public health. Conditions authorized by 

section 564(e) of the act include, for 

example: (1) Requirements for 

information dissemination to health 

care providers or authorized dispensers 

and product recipients; (2) adverse 

event monitoring and reporting; (3) data 

collection and analysis; (4) 

recordkeeping and records access; (5) 

restrictions on product advertising, 

distribution, and administration; and (6) 

limitations on good manufacturing 

practices requirements. Some 

conditions, the statute specifies, are 

mandatory to the extent practicable for 

authorizations of unapproved products 

and discretionary for authorizations of 

unapproved uses of approved products. 

Moreover, some conditions may apply 

to manufacturers of an EUA product, 

while other conditions may apply to any 

person who carries out any activity for 

which the authorization is issued. 

Section 564 of the act also gives the 

Commissioner authority to establish 

other conditions on an authorization 

that he finds to be necessary or 

appropriate to protect the public health. 

For purposes of estimating the burden 

of reporting, FDA has established six 

categories of respondents: (1) Those 

who file a Request for Consideration for 

an EUA after a determination of actual 

or potential emergency and, in lieu of 

submitting the data, provide reference to 

a pending or approved application; (2) 

those who file a Request for 

Consideration for an EUA and the data 

after a determination of actual or 

potential emergency, without reference 

to a pending or approved application; 

(3) those who submit data to FDA on a 

candidate EUA product, which is 

subject to a pending or approved 

application, prior to a determination of 

actual or potential emergency; (4) those 

who submit data to FDA prior to a 

determination of actual or potential 

emergency about a candidate EUA 

product for which there is no pending 

or approved application; (5) 

manufacturers of an unapproved EUA 

product who must report to FDA 

regarding such activity; and (6) state and 

local public health officials who carry 

out an activity related to an unapproved 

EUA product (e.g., administering the 

product to civilians) and who must 

report to FDA regarding such activity. 

For purposes of estimating the burden 

of recordkeeping, FDA has calculated 

the anticipated burden on 

manufacturers of unapproved products 

authorized for emergency use. The 

Agency anticipates that the federal 

government will perform some of the 

additional recordkeeping necessary for 

unapproved products (e.g., related to the 

administration of unapproved EUA 

products to military personnel). FDA 

also anticipates that some state and 

local public health officials may be 

required to perform additional 

recordkeeping (e.g., related to the 

administration of unapproved EUA 

products to civilians) and calculated a 

recordkeeping burden for those 

activities. 

No burden was attributed to reporting 

or recordkeeping for unapproved uses of 

approved products, since those products 

already are subject to approved 

collections of information (Adverse 

Experience Reporting for biological 

products is approved under OMB 

Control No. 0910–0308 through 

September 30, 2011; Adverse Drug 


rmajette on PRODPC74 with NOTICES
17964 Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices 

Experience Reporting is approved under 

OMB Control No. 0910–0230 through 

April 30, 2009; and IND regulations are 

approved under OMB Control No. 0910– 

0014 through May 31, 2009) and any 

additional burden imposed by this 

proposed collection would be minimal. 

Thus, FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Request for Consideration; Pending 

Application on File 1 1 1 15 15 

Request for Consideration; No Application Pending 1 1 1 50 50 

Pre-Emergency Submissions; Pending Application on File 10 1 10 20 200 

Pre-Emergency Submissions; No Application Pending 3 1 3 75 225 

Manufacturers of an Unapproved 

EUA Product 3 4 12 2 24 

State and Local Public Health Officials; Unapproved EUA Product 30 4 120 2 240 

Total 754 

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

TABLE 2.—ESTIMATED RECORDKEEPING ANNUAL BURDEN1

No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

Manufacturers of an Unapproved 

EUA Product 3 4 12 25 300 

State and Local Public Health Officials; Unapproved EUA Product 30 4 120 3 360 

Total 660 

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

The annual burden estimate for this 

information collection is 1,414 hours. 

The estimated reporting burden for this 

collection is 754 hours and the 

estimated recordkeeping burden is 660 

hours. 

Dated: April 10, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8922 Filed 4–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Evaluation of Networking 

Suicide Prevention Hotlines (OMB No. 

0930–0274)—Revision 

This project revision includes the 

continuation of two previously 

approved data collection activities 

[Evaluation of Networking Suicide 

Prevention Hotlines Follow-Up 

Assessment (OMB No. 0930–0274) and 

Call Monitoring of National Suicide 

Prevention Lifeline Form (OMB No. 

0930–0275)], and a revision to expand 

the scope of the ongoing evaluation in 

an effort to advance the understanding 

of crisis hotline utilization and its 

impact. The Substance Abuse and 

Mental Health Services 

Administration’s (SAMHSA), Center for 

Mental Health Services (CMHS) funds a 

National Suicide Prevention Lifeline 

Network (NSPL), consisting of two tollfree telephone numbers, that route calls 

from anywhere in the United States to 

a network of local crisis centers. In turn, 

the local centers link callers to local 

emergency, mental health, and social 

service resources. 

The overarching purpose of the 

proposed Evaluation of the Networking 

Suicide Prevention Hotlines—Revision 

is to (1) continue to monitor and ensure 

quality of calls and gather follow-up 

information from the callers themselves, 

(2) expand the number of centers 

participating in order to assess whether 

the two national suicide prevention 

hotline numbers (i.e., 1–800–273–TALK 

and 1–800–SUICIDE) reach similar or 

complimentary populations of at risk 

callers, and, (3) to evaluate additional 

but related activities (e.g., motivational 

interviewing and safety planning) 

recently funded through a new 

cooperative agreement between 


rmajette on PRODPC74 with NOTICES