Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 51285 

demographic questions will be 

included. The form will ask participants 

to report demographic information, 

education, profession, field of study, 

status of certification or licensure, 

workplace role, and employment 

setting. 

Follow-up Form for Training: The 

Follow-up Information Form for 

Training asks about 25 questions of 

about 25% of consenting participants. 

The approved form asks the participants 

to report satisfaction with, usefulness of, 

and quality of the training and training 

materials as well as to assess their level 

of skills in the topic area. The form also 

asks participants to report whether or 

not they have shared information from 

the event at their place of work and 

which, if any, barriers they have 

encountered to applying the information 

gained from the training. This form is 

already approved by OMB and will not 

be revised (OMB #0930–0216). 

The information collected on the 

ATTC forms will assist CSAT in 

documenting the numbers and types of 

participants in ATTC events, describing 

the extent to which participants report 

improvement in their clinical 

competency, and which method is most 

effective in disseminating knowledge to 

various audiences. This type of 

information is crucial to support CSAT 

in complying with GPRA reporting 

requirements and will inform future 

development of knowledge 

dissemination activities. 

The chart below summarizes the 

annualized burden for this project. 

Type of respondent Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Total annual 

burden hours 

Faculty/staff Event Description Form ............................................................... 250 1 .25 62.50 

Meeting and Technical Assistance Participants: 

Post-Event Form ....................................................................................... 5,000 1 .12 600 

Follow-up Form ......................................................................................... Covered under CSAT Government Performance and Results Act 

(GPRA) Customer Satisfaction form (OMB #0930–0197) 

Training Participants: 

Post-Event Form ....................................................................................... 30,000 1 .16 4,800 

Follow-up Form ......................................................................................... 7,500 1 .16 1,200 

Total ................................................................................................... 42,750 6,662.50 

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: September 28, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–24017 Filed 10–5–09; 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; Submission for Office of 

Management and Budget Review; 

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 

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 November 

5, 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 0910–0595. 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, 

JonnaLynn.Capezzuto@fda.hhs.gov. 

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. 

Draft Guidance, 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 emergency 

use authorizations (EUA) 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 (Pub. L. 

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 FDA 

Commissioner may establish conditions 

on the approval of an EUA. Section 

564(e) requires the FDA Commissioner 

(to the extent practicable given the 


jlentini on DSKJ8SOYB1PROD with NOTICES
51286 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 

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 FDA 

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: 

Requirements for information 

dissemination to health care providers 

or authorized dispensers and product 

recipients; adverse event monitoring 

and reporting; data collection and 

analysis; recordkeeping and records 

access; restrictions on product 

advertising, distribution, and 

administration; and 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 FDA 

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 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, 

without reference to a pending or 

approved application; (3) those who 

submit pre-EUA submissions to FDA on 

a candidate EUA product, which 

references a pending or approved 

application; (4) those who submit preEUA submissions to FDA on a candidate 

EUA product, for which there is no 

reference to a 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 

recipients) 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. 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 

experience reporting is approved under 

OMB Control No. 0910–0230 through 

July 31, 2012; investigational new drug 

application regulations are approved 

under OMB Control No. 0910–0014 

through August 31, 2011; and 

investigational device exemption 

reporting is approved under OMB 

Control Number 0910–0078 through 

January 31, 2010). 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 

Requests for Consideration; 

Pending Application on File 5 2 10 15 150 

Requests for Consideration; No 

Application Pending 4 2 8 50 400 

Pre-EUA Submissions; Pending 

Application on File 2 2 4 20 80 

Pre-EUA Submissions; No Application Pending 11 2 22 75 1,650 

Manufacturers of an Unapproved 

EUA Product 3 4 12 2 24 

State and Local Public Health Officials; Unapproved EUA Product 30 4 360 2 240 

Total 2,544 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 51287 

TABLE 2.—ESTIMATED RECORDKEEPING ANNUAL BURDEN1—Continued 

No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

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 3,204 hours. 

The estimated reporting burden for this 

collection is 2,544 hours, and the 

estimated recordkeeping burden is 660 

hours. 

In the Federal Register of April 20, 

2009 (74 FR 17962), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. However, in the period of time 

since the 60-day notice was drafted, 

there was a determination of public 

health emergency involving the 2009 

H1N1 virus and multiple declarations 

supporting the issuance of EUAs. As a 

result of this increased activity and the 

likelihood of a continued increase in the 

number of EUA and pre-EUA 

submissions, on its own initiative, FDA 

is providing estimates based on the 

number of reports that the agency 

received in the past year. 

Dated: September 29, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24048 Filed 10–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0465] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Additive 

Petitions 

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 

food additive petitions regarding animal 

feed. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 7, 2009. 

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: 

Denver Presley Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

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. 

Food Additive Petitions—21 CFR Part 

571 (OMB Control Number 0910– 

0546)—Extension 

Section 409(a) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 348(a)) provides that a food 

additive shall be deemed to be unsafe 

unless its use is permitted by a 

regulation which prescribes the 

condition(s) under which it may safely 

be used, or unless it is exempted by 

regulation for investigational use. 

Section 409(b) of the act specifies the 

information that must be submitted by 

a petition in order to establish the safety 

of a food additive and to secure the 

issuance of a regulation permitting its 

use. 

To implement the provision of section 

409 of the act, procedural regulations 

have been issued under part 571 (21 

CFR part 571). These procedural 

regulations are designed to specify more 

thoroughly the information that must be 

submitted to meet the requirement set 

down in broader terms by the law. The 

regulations add no substantive 

requirements to those indicated in the 

law, but seek to explain the 

requirements and provide a standard 

format for submission of petitions, that 

when implemented, will speed up the 

time for processing. Labeling 

requirements for food additives 

intended for animal consumption are 

also set forth in various regulations 

contained in 21 CFR parts 573, 582, and 

584. The labeling regulations are 

considered by FDA to be crossreferenced to § 571.1, which is the 

subject of this same OMB clearance for 

food additive petitions. 

FDA estimates the burden of this 

collection of information as follows: 


jlentini on DSKJ8SOYB1PROD with NOTICES