40212 Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices 

observations that are communicated to a 

firm through issuance of a form FDA 

483, list of inspectional observations. 

DATES: The program will begin on 

September 15, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Karen Stutsman, Division of 

Compliance Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 240–632–6860. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA issues a form FDA 483, 

Inspectional Observations, upon 

completion of an inspection, to notify 

an inspected establishment’s top 

management of objectionable conditions 

relating to products and/or processes, or 

other violations of the Federal Food, 

Drug, and Cosmetic Act and related acts, 

that were observed during the 

inspection. 

The FDA 483 form includes this 

preprinted instruction: ‘‘This document 

lists observations made by the FDA 

representative(s) during the inspection 

of your facility. They are inspectional 

observations; and do not represent a 

final agency determination regarding 

your compliance. If you have an 

objection regarding an observation, or 

have implemented, or plan to 

implement corrective action in response 

to an observation, you may discuss the 

objection or action with the FDA 

representative(s) during the inspection 

or submit this information to FDA at the 

address [on the form].’’ 

When FDA determines, based on the 

inspection, that the establishment is in 

violation of the Federal Food, Drug, and 

Cosmetic Act or another statute that we 

enforce, we may issue a warning letter. 

Warning letters are issued only for 

significant violations that may lead to 

enforcement action if they are not 

promptly and adequately corrected. The 

decision to issue a warning letter is 

made by senior officials within FDA, 

often including the product center, after 

a thorough review of all of the relevant 

facts. 

It is not uncommon for an inspected 

establishment to respond in writing to 

observations made on an FDA 483 to 

describe completed or ongoing 

corrective actions or to promise future 

corrections. In fact, some inspected 

establishments submit multiple 

responses to FDA, sometimes over many 

months. Delayed and multiple 

responses to an FDA 483 have resulted 

in delays in the issuance of warning 

letters while these responses are 

reviewed and addressed. FDA’s timely 

issuance of a warning letter should help 

to achieve prompt voluntary compliance 

and is therefore in the public interest. 

While FDA considers corrective 

actions, and other factors, in 

determining whether to issue a warning 

letter, ongoing or promised corrective 

actions generally do not preclude the 

issuance of a warning letter. A warning 

letter is an important means of notifying 

regulated industry of violations and 

achieving prompt voluntary correction. 

Warning letters serve to ensure that the 

seriousness and scope of the violations 

are understood by top management of 

the inspected establishment, and that 

the appropriate resources are allocated 

to fully correct the violations and to 

prevent their recurrence. FDA is 

initiating a program to establish a 

timeframe for the submission of such 

post-inspection responses to FDA 483 

inspectional observations for FDA’s 

consideration in deciding whether to 

issue a warning letter. Under the 

program (described in more detail later 

in this document), the agency will not 

ordinarily delay the issuance of a 

warning letter in order to review a 

response to an FDA 483 that is received 

more than 15 business days after the 

FDA 483 was issued. 

The purpose of this program is to 

optimize resource utilization, facilitate 

the timely issuance of warning letters, 

and promote prompt correction of 

violations. FDA will use the information 

from the program to determine whether 

to make the program permanent. FDA 

will conduct an assessment of the 

program after approximately 18 months. 

II. Program Description 

Under the program, before issuing a 

warning letter, FDA will generally allow 

firms 15 business days to provide a 

response to FDA 483 observations. If we 

receive a response to FDA 483 

observations within 15 business days 

after the FDA 483 was issued, we plan 

to conduct a detailed review of the 

response before determining whether to 

issue a warning letter. If we issue a 

warning letter after reviewing a firm’s 

timely response, the warning letter will 

recognize receipt of the response and 

reply as to the apparent adequacy of the 

firm’s corrective actions set forth in the 

response. Additional correspondence 

from FDA may be issued with regard to 

the response, if needed. 

If we receive a response to FDA 483 

observations more than 15 business 

days after the FDA 483 was issued, we 

do not plan to routinely include a 

response on the apparent adequacy of 

the firm’s corrective actions in the 

warning letter. Rather, we plan to 

evaluate the response along with any 

other written material provided as the 

direct response to the warning letter (a 

firm’s response to a warning letter may 

reference any of the firm’s earlier 

responses). 

Note that FDA, at its discretion, may 

issue Warning Letters at any time, 

independent of receiving a response; 

and that firms are expected to 

implement needed corrections to 

conform to the requirements of the 

Federal Food, Drug, and Cosmetic Act 

and associated regulations regardless of 

whether they respond in writing to FDA 

or whether such a response is reviewed 

by FDA. 

After the 18-month time period, FDA 

will evaluate this program and decide 

whether to continue it with or without 

adjustments. 

Dated: August 4, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19107 Filed 8–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID FEMA–2009–0001] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice; 60-day notice and 

request for comments; revision of a 

currently approved information 

collection; OMB No. 1660–0099; FEMA 

Form 646–0, Citizen Corps Individual 

Registration. 

SUMMARY: The Federal Emergency 

Management Agency, as part of its 

continuing effort to reduce paperwork 

and respondent burden, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on a proposed revision of a 

currently approved information 

collection. In accordance with the 

Paperwork Reduction Act of 1995, this 

Notice seeks comments concerning the 

online registration process for Citizen 

Corps Individual Registration. 

DATES: Comments must be submitted on 

or before October 13, 2009. 

ADDRESSES: To avoid duplicate 

submissions to the docket, please use 

only one of the following means to 

submit comments: 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices 40213 

(1) Online. Submit comments at 

www.regulations.gov under docket ID 

FEMA–2009–0001. Follow the 

instructions for submitting comments. 

(2) Mail. Submit written comments to 

Office of Chief Counsel, Regulation and 

Policy Team, DHS/FEMA, 500 C Street, 

SW., Room 835, Wash, DC 20472–3100. 

(3) Facsimile. Submit comments to 

(703) 483–2999. 

(4) E-mail. Submit comments to 

FEMA–POLICY@dhs.gov. Include 

docket ID FEMA–2009–0001 in the 

subject line. 

All submissions received must 

include the agency name and docket ID. 

Regardless of the method used for 

submitting comments or material, all 

submissions will be posted, without 

change, to the Federal eRulemaking 

Portal at http://www.regulations.gov, 

and will include any personal 

information you provide. Therefore, 

submitting this information makes it 

public. You may wish to read the 

Privacy Act notice that is available on 

the Privacy and Use Notice link on the 

Administration Navigation Bar of 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Contact Kerry Hoerth, Community 

Preparedness Division Program 

Specialist, FEMA, 202–786–9775 for 

additional information. You may 

contact the Records Management 

Branch for copies of the proposed 

collection of information at facsimile 

number (202) 646–3347 or e-mail 

address: FEMA–InformationCollections@dhs.gov. 

SUPPLEMENTARY INFORMATION: Citizen 

Corps was launched as a Presidential 

Initiative, Executive Order 13254, in 

2002 with a mission to harness the 

power of every individual through 

education, training, and volunteer 

service to make communities safer, 

stronger, and better prepared for the 

threats of terrorism, crime, public health 

issues, and disasters of all kinds. In 

order to fulfill its mission, the Federal 

Emergency Management Agency 

(FEMA) Community Preparedness 

Division (CPD) requires individuals to 

submit profiles electronically through 

its information collection online process 

and forms. 

Collection of Information 

Title: Citizen Corps Individual 

Registration. 

Type of Information Collection: 

Revision of a currently approved 

information collection. 

OMB Number: OMB No. 1660–0099. 

Form Titles and Numbers: FEMA 

Form 646–0, Citizen Corps Individual 

Registration. 

Abstract: FEMA’s Community 

Preparedness Division (CPD) would like 

to revise a currently approved collection 

for its individual registration to allow 

members of the public to provide 

contact information to receive national 

programmatic updates and 

announcements such as upcoming 

preparedness demonstrations and 

training opportunities and the 

opportunity to get involved in local 

organizations and events. 

Affected Public: Individuals or 

households. 

Estimated Total Annual Burden 

Hours: 1,600 burden hours. 

ANNUAL HOUR BURDEN

TABLE A.12—ESTIMATED ANNUALIZED BURDEN HOURS AND COSTS

Type of respondent Form name/ 

form No. 

Number of respondents 

Number of responses per 

respondent 

Avg. burden 

per response 

(in hours) 

Total annual 

burden (in 

hours) 

Avg. hourly 

wage rate* 

Total annual 

respondent 

cost 

Individuals or households ......................... FEMA Form 20,000 1 5 minutes 

(.08 hours) 

1,600 27.38 43,808.00 

Total ...................... ........................ 20,000 ........................ ........................ 1,600 ........................ 43,808.00 

* Note: The ‘‘Avg. Hourly Wage Rate’’ for each respondent includes a 1.4 multiplier to reflect a fully-loaded wage rate. 

Estimated Cost: None. 

Comments 

Comments may be submitted as 

indicated in the ADDRESSES caption 

above. Comments are solicited to (a) 

evaluate whether the proposed data 

collection is necessary for the proper 

performance of the agency, including 

whether the information shall have 

practical utility; (b) evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) minimize the burden 

of the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Larry Gray, 

Director, Records Management Division, 

Office of Management, Federal Emergency 

Management Agency, Department of 

Homeland Security. 

[FR Doc. E9–19154 Filed 8–10–09; 8:45 am] 

BILLING CODE 9111–05–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID: FEMA–2009–0001] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice; 60-day notice and 

request for comments; revision of a 

currently approved information 

collection; OMB No. 1660–0098; FEMA 

Form 646, Citizen Corps Council 

Registration. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA), as part of 

its continuing effort to reduce 

paperwork and respondent burden, 

invites the general public and other 

Federal agencies to take this 

opportunity to comment on a proposed 

revision of a currently approved 

information collection. In accordance 

with the Paperwork Reduction Act of 

1995, this Notice seeks comments 

concerning the online database of 

Citizen Corps Councils and Community 

Emergency Response Team (CERT) so 

that they can submit profiles via the 

national Web site. Approved registration 

of a Council or CERT program allows 

them to be recognized as official entities 


sroberts on DSKD5P82C1PROD with NOTICES