Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 52765 

Xenobiotic and Nutrient Disposition and 

Action Study Section. 

Date: October 6, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Patricia Greenwel, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2172, 

MSC 7818, Bethesda, MD 20892. 301–435– 

1169. greenwep@csr.nih.gov. 

Name of Committee: Cardiovascular and 

Respiratory Sciences Integrated Review 

Group, Myocardial Ischemia and Metabolism 

Study Section. 

Date: October 6–7, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Westin St. Francis, 335 Powell 

Street, San Francisco, CA 94102. 

Contact Person: Joseph Thomas Peterson, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4118, 

MSC 7814, Bethesda, MD 20892. 301–443– 

8130. petersonjt@csr.nih.gov. 

Name of Committee: Bioengineering 

Sciences & Technologies Integrated Review 

Group, Gene and Drug Delivery Systems 

Study Section. 

Date: October 6–7, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Nikko San Francisco, 222 

Mason Street, San Francisco, CA 94102. 

Contact Person: Amy L Rubinstein, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5152, 

MSC 7844, Bethesda, MD 20892. 301–408– 

9754. rubinsteinal@csr.nih.gov. 

Name of Committee: Cell Biology 

Integrated Review Group, Molecular and 

Integrative Signal Transduction Study 

Section. 

Date: October 6–7, 2010. 

Time: 8 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sir Francis Drake Hotel, 450 Powell 

Street at Sutter, San Francisco, CA 94102. 

Contact Person: Raya Mandler, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5134, 

MSC 7840, Bethesda, MD 20892. (301) 402– 

8228. rayam@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Small 

Business: Neuroscience Education. 

Date: October 6–7, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting.) 

Contact Person: Jonathan Arias, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5170, 

MSC 7840, Bethesda, MD 20892. 301–435– 

2406. ariasj@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: August 23, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–21357 Filed 8–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Molecular Genetics B 

Study Section, October 3, 2010, 7 p.m. 

to October 4, 2010, 8 a.m., The Fairmont 

Hotel, 950 Mason Street, San Francisco, 

CA 94108 which was published in the 

Federal Register on August 19, 2010, 75 

FR 51277–51278. 

The meeting will be held October 4, 

2010, 7 p.m. to October 5, 2010, 6 p.m. 

The meeting location remains the same. 

The meeting is closed to the public. 

Dated: August 19, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–21352 Filed 8–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0437] 

Development and Distribution of 

Patient Medication Information for 

Prescription Drugs; Public Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; 

request for comment. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

2-day public hearing to obtain input on 

a new framework for development and 

distribution of patient medication 

information (PMI) to be provided to 

patients who are prescribed drug 

products. Under the current system, 

patients may receive several different 

types of information, developed by 

different sources that may be 

duplicative, incomplete, or difficult to 

read and understand. FDA has 

determined that the current system is 

not adequate to ensure that patients 

receive the essential medication 

information that is needed to use the 

drug safely. Based on recommendations 

from FDA’s Risk Communication 

Advisory Committee (RCAC) and other 

stakeholder input, FDA sees merit in 

adopting use of a single document that 

is standardized with respect to content 

and format. The purpose of this hearing 

is to solicit public input on processes 

and procedures for standardizing PMI 

using a quality system approach for 

monitoring development and 

distribution of PMI. 

DATES: The public hearing will be held 

on September 27 and 28, 2010, from 

8:30 a.m. to 4:30 p.m. Registration 

requests and requests to present at the 

public hearing should be received by 

September 13, 2010 (see section III of 

this document for details). Electronic or 

written comments will be accepted after 

the public hearing until October 29, 

2010 (see section V of this document for 

details). 

ADDRESSES: The public hearing will be 

held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

rm. 1503, Silver Spring, MD 20993. To 

register for the public hearing, email 

your registration information to 

PMIpublicmeeting@fda.hhs.gov. See 

section III of this document for 

registration details. Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denise Hinton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6348, 

Silver Spring, MD 20993, 301–796– 

1090, FAX: 301–847–3529, email: 

PMIpublicmeeting@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Ensuring that patients who are 

prescribed medical products have 

access to quality information about 

those products is an important 

component of medical product safety. 

Currently, patients receive multiple 

types of written prescription drug 

information in varying formats, which 

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52766 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 

1FDA has verified the Web site address, but FDA 

is not responsible for any subsequent changes to the 

Web site after this document publishes in the 

Federal Register. 

complicates information accessibility 

and comprehension. The types of 

written prescription drug information 

include: 

• Consumer Medication Information 

(CMI) is written information about 

prescription drugs developed by 

organizations or individuals other than 

a drug manufacturer that is intended for 

distribution to consumers at the time of 

drug dispensing. The information is not 

FDA reviewed or approved and is 

voluntarily distributed by pharmacies to 

consumers (Ref. 1). 

• A Patient Package Insert (PPI) is 

patient labeling that is part of the FDAapproved prescription drug labeling. 

PPIs are developed by the manufacturer, 

approved by FDA, and are required to 

be dispensed with specific products or 

classes of products (i.e., oral 

contraceptives and estrogen-containing 

products). Other PPIs are submitted to 

FDA voluntarily by the manufacturer 

and approved by FDA, but their 

distribution is not mandated. 

• A Medication Guide is also patient 

labeling that is part of the FDAapproved prescription drug labeling. 

Medication Guides are required for 

certain drugs ‘‘that pose a serious and 

significant public health concern’’ (see 

21 CFR part 208). Medication Guides are 

developed by the manufacturer, 

approved by FDA, and are required to 

be given to patients each time the 

medication is dispensed. 

By objective measures, current 

systems for providing high quality, 

easily accessible prescription 

medication information to patients have 

failed. For example, an evaluation of 

CMI in 2008 showed that while 94 

percent of consumers receive CMI with 

new prescriptions, only 75 percent of 

CMI received met even minimum 

criteria for usefulness (Ref 2.). FDA 

presented these concerns to the RCAC at 

a February 26 and 27, 2009 meeting. 

That committee recommended that FDA 

adopt a standard, single document for 

communicating essential information 

about prescription drugs to replace CMI, 

PPIs, and Medication Guides. FDA is 

engaged in a collaborative effort to 

explore this recommendation. 

The major challenges in providing 

patients with quality prescription drug 

information are as follows: (1) 

Development of uniform, evidencebased content and format standards for 

PMI, including that the PMI contains 

the essential information about the drug, 

and is accurate, balanced, 

comprehensible, and accessible; (2) 

identification and assessment of 

mechanisms to ensure that PMI meets 

these standards; and (3) identification 

and assessment of mechanisms to 

ensure that the PMI reaches its target 

audience. This public hearing is 

intended to focus primarily on issues 2 

and 3, and related issues, while the first 

issue is being addressed separately, as 

discussed in the following paragraphs. 

There are two key limitations that 

underpin FDA’s expectations for how 

improvements in providing patient 

information might be structured. First, 

although one approach could include 

FDA review and approval of all PMI 

prior to distribution, FDA recognizes 

that this may not be feasible given 

FDA’s resource constraints and the 

potential volume of products that will 

require PMI (perhaps as many 22,000 if 

counting all innovator and generic 

products). Second, based on FDA’s 

compliance and enforcement experience 

in a variety of program areas, including 

professional labeling, manufacturing, 

and clinical trials, FDA recognizes that 

relying primarily or exclusively on 

retrospective Agency evaluations and 

inspections may not be an optimal 

approach to providing assurance that 

PMI meets format and content standards 

prior to distribution to patients. For 

these reasons, FDA is interested in 

exploring an approach centered on 

effective processes for PMI development 

and distribution and process controls 

for a PMI implementation program. 

With a system in place that assures high 

quality PMI, FDA believes that 

development of PMI by the 

manufacturer would be more efficient 

and fulfill the information needs of 

patients. 

Such an approach for PMI would 

provide manufacturers with a quality 

framework for developing, distributing, 

and amending PMI and would facilitate 

continual improvement of PMI. FDA 

envisions that this approach would 

provide assurance that manufacturers 

have implemented the following: (1) 

Effective procedures for developing PMI 

that reflect quality standards for PMI 

content and format, for ensuring 

appropriate distribution, and for 

ensuring PMI revision if necessary; (2) 

mechanisms to monitor whether these 

procedures are being followed; and (3) 

mechanisms to implement process 

changes as needed. 

Because it will take a substantial 

amount of time to transition from the 

existing system to the use of a standard, 

single document for PMI, FDA is also 

seeking public input on a potential 

structure and challenges and solutions 

for a step-wise transition to a new PMI 

paradigm. 

As described in the explanation of 

major challenges earlier in this 

document, FDA is also continuing its 

efforts and seeking additional 

information to identify and assess the 

development of format and content 

standards for PMI as a standard, single 

document. With input from the 

following sources FDA has developed 

three draft PMI prototypes to be used in 

consumer testing: 

(1) FDA’s RCAC meeting (Ref. 3); 

(2) a public workshop held on 

September 24 and 25, 2009 (available at 

http://www.fda.gov/Drugs/NewsEvents/ 

ucm168106.htm); and 

(3) an expert panel meeting convened 

by the Brookings Institute on July 21, 

2010 (available at http:// 

www.brookings.edu/events/2010/ 

0721_CMI.aspx),1

Based on public comment (75 FR 23775, 

May 4, 2010) and expert panel input, 

FDA is also finalizing the design of the 

consumer testing study for the 

prototypes (available on the Internet at 

http://edocket.access.gpo.gov/2010/pdf/ 

2010-10359.pdf). Consumer testing will 

begin when the final study design is 

approved by the Office of Management 

and Budget. The results of this study 

will inform FDA of the usefulness and 

parameters of various format options for 

patient information documents. FDA is 

interested in any formal research 

conducted on this topic and encourages 

submission to this docket. See section 

III of this document for details on how 

to register and or participate in the 

meeting. See section V of this document 

for details on how to post comments to 

the docket. 

II. Scope of the Hearing 

FDA is particularly interested in 

seeking input on the following issues: 

(1) How can we best ensure PMI 

quality and compliance with content 

and format criteria? 

• What are the elements that should be 

addressed with a quality system 

approach, or other type of system, to 

ensure PMI quality? 

• What functions and procedures 

should be the responsibility of 

manufacturers (e.g., PMI development, 

consumer testing, marketplace 

surveillance)? 

• What functions and procedures 

should be FDA’s responsibility (e.g., 

surveillance, audit, enforcement)? 

• Are there a subset of products that 

should receive more regulatory scrutiny 

than would be provided by an approach 

that relies heavily on manufacturers 

implementing and monitoring the 

adequacy of procedures for generating 

PMI content (i.e., types of products for 

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Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 52767 

which PMI should be prospectively 

reviewed and approved by FDA before 

use)? If so, what categories of drugs 

might be included in this subset? What 

other approaches to ensuring quality 

should be considered for drugs in this 

subset? 

• At what time-point should 

evaluation of the PMI be initiated and 

how often should it be repeated? 

(2) What are the components of an 

effective framework for ensuring patient 

access to PMI? 

• Who should be responsible for 

processes to ensure distribution of PMI? 

• What types of processes are needed 

to ensure distribution of PMI? For 

example, should there be a process or 

system to monitor patient receipt of 

PMI? 

• How can we ensure adequate 

distribution of PMI while minimizing 

disruption to health care delivery 

processes (e.g., medical practice, 

pharmacy practice)? 

• Are there situations where the 

distribution of PMI would not be 

appropriate (e.g., for medications 

administered by a health care 

professional in an inpatient or 

outpatient setting, dialysis unit, 

oncology setting, or operating room)? 

• Should there be a centralized 

repository for all PMI? If so, how might 

a repository be implemented and 

maintained to ensure the integrity and 

sustainability of the repository? Are 

there relevant, existing systems that 

could serve as a business model for a 

central PMI repository? 

(3) What approaches should be 

considered to ensure that FDA can 

rapidly move from the current system to 

a new PMI paradigm? 

• How might the existing framework 

be phased if a new framework is phased 

in? 

• How should a new PMI system be 

applied to generic drugs? 

(4) What accommodations might be 

needed to ensure that PMI is accessible 

to special populations (e.g., elderly, 

children, those with low literacy, the 

visually impaired)? 

III. How to Register and/or Participate 

in the Public Hearing 

FDA is seeking input from a broad 

group of stakeholders, including 

interested prescribers, pharmacists, 

other health care professionals, 

consumers, pharmacies, CMI 

developers, publishers, industry, and 

any other interested parties. FDA’s 

Conference Center at the White Oak 

Campus is a Federal facility with 

security procedures and limited seating. 

Attendance is free and will be on a firstcome, first-served basis. To register for 

the public hearing, email your 

registration to 

PMIpublicmeeting@fda.hhs.gov. 

Registration information should include 

registrant name, company or 

organization, address, phone number, 

and email address. Because seating is 

limited, FDA may limit the numbers of 

participants from each organization. 

Registrants will receive confirmation 

once they have been accepted for 

participation in the workshop. Onsite 

registration on the day of the hearing 

will be based on space availability on 

the day of the event starting at 7:30 a.m. 

If registration reaches maximum 

capacity, FDA will post a notice closing 

meeting registration for the hearing at 

http://www.fda.gov/Drugs/NewsEvents/ 

ucm219716.htm. 

Individuals who wish to present at 

the public hearing must register on or 

before September 13, 2010, through the 

email PMIpublicmeeting@fda.hhs.gov, 

and state this intention on their notice 

of participation. An abstract of the 

presentation along with slides are due 

on September 17, 2010. You must 

provide complete contact information, 

including name, title, affiliation, 

address, email, and phone number. In 

section II of this document, FDA has 

included questions for comment. You 

should identify by number each 

question you wish to address in your 

presentation, so that FDA can consider 

that in organizing the presentations. 

FDA will do its best to accommodate 

requests to speak, and will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. An agenda will be available 

approximately 1 week before the 

hearing at http://www.fda.gov/Drugs/ 

NewsEvents/ucm219716.htm. 

If you need special accommodations 

because of disability, please contact 

Denise Hinton (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the hearing. 

A live webcast of this hearing will be 

viewable at https:// 

collaboration.fda.gov/p15d109272010/ 

on September 27 and https:// 

collaboration.fda.gov/p15d209272010/ 

on September 28. If you have never 

attended an Adobe® Acrobat® 

ConnectTM Pro meeting before, test your 

connection at https:// 

collaboration.fda.gov/common/help/en/ 

support/meeting_test.htm. For a quick 

overview, go to http://www.adobe.com/ 

go/connectpro_overview. 

IV. Notice of Hearing Under Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with part 15 

(21 CFR part 15). The hearing will be 

conducted by a presiding officer, who 

will be accompanied by senior 

management from the Office of the 

Commissioner, the Center for Drug 

Evaluation and Research, and the Center 

for Biologics and Research. 

Under § 15.30(f), the hearing is 

informal and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. Public hearings under part 

15 are subject to FDA’s policy and 

procedures for electronic media 

coverage of FDA’s public administrative 

proceedings (part 10, subpart C (21 CFR 

part 10, subpart C)). Under § 10.205, 

representatives of the electronic media 

may be permitted, subject to certain 

limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b) (see section VI of this 

document). To the extent that the 

conditions for the hearing, as described 

in this notice, conflict with any 

provisions set out in part 15, this notice 

acts as a waiver of those provisions as 

specified in § 15.30(h). 

V. Comments 

Regardless of attendance at the public 

hearing, interested persons may submit 

to the Division of Dockets Management 

(see ADDRESSES) either electronic or 

written comments. It is only necessary 

to send one set of comments. It is no 

longer necessary to send two copies of 

mailed comments. Identify comments 

with the docket number found in 

brackets in the heading of this 

document. To ensure consideration, 

submit comments by October 29, 2010. 

Received comments may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

VI. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

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52768 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 

2FDA has verified the Web site address, but FDA 

is not responsible for any subsequent changes to the 

Web site after this document publishes in the 

Federal Register. 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

VII. References 

1. ‘‘Useful Written Consumer 

Medication Information (CMI)’’ 

published in July 2006, available on the 

Internet at http://www.fda.gov/ 

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

ucm080602.pdf. 

2. Kimberlin CL, Winterstein AG. 

‘‘Expert and Consumer Evaluation of 

Consumer Medication Information— 

2008.’’ Final Report to FDA. November 

2008 available on the Internet at http:// 

www.fda.gov/downloads/AboutFDA/ 

CentersOffices/CDER/ReportsBudgets/ 

UCM163783.pdf. 

3. FDA’s Risk Communication 

Advisory Committee meeting, held on 

February 26 and 27, 2009 (73 FR 74505, 

December 8, 2008), available on the 

Internet at http://www.fda.gov/ 

downloads/AdvisoryCommittees/ 

CommitteesMeetingMaterials/ 

RiskCommunication

AdvisoryCommittee/UCM152593.pdf. 

4. ‘‘Providing Effective Information to 

Consumers about Prescription Drug 

Risks and Benefits—The Issues Paper’’ 

from the 2009 public workshop 

available on the Internet at http:// 

www.fda.gov/downloads/Drugs/ 

NewsEvents/UCM182799.pdf. 

5. ‘‘Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental Study 

of Patient Information Prototypes,’’ 

available on the Internet at2 http:// 

edocket.access.gpo.gov/2010/pdf/2010- 

10359.pdf 

Dated: August 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21326 Filed 8–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0002] 

Withdrawal of Approval of New Animal 

Drug Applications; Dichlorophene and 

Toluene Capsules 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of two new animal drug 

applications (NADAs) for use of 

dichlorophene and toluene deworming 

capsules for cats and dogs. In a final 

rule published elsewhere in this issue of 

the Federal Register, FDA is amending 

the regulations to remove portions 

reflecting approval of these NADAs. 

DATES: Withdrawal of approval is 

effective September 7, 2010. 

FOR FURTHER INFORMATION CONTACT: John 

Bartkowiak, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9079; 

email: john.bartkowiak@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pegasus 

Laboratories, Inc., 8809 Ely Rd., 

Pensacola, FL 32514 has requested that 

FDA withdraw approval of NADA 101– 

497 for TINY TIGER (dichlorophene/ 

toluene) Worming Capsules, NADA 

101–498 for LK (dichlorophene/toluene) 

Worming Capsules because they are no 

longer manufactured or marketed. 

Therefore, under authority delegated 

to the Commissioner of Food and Drugs 

and redelegated to the Center for 

Veterinary Medicine, and in accordance 

with § 514.116 Notice of withdrawal of 

approval of application (21 CFR 

514.116), notice is given that approval 

of NADAs 101–497 and 101–498, and 

all supplements and amendments 

thereto, is hereby withdrawn, effective 

September 7, 2010. 

In a final rule published elsewhere in 

this issue of the Federal Register, FDA 

is amending the animal drug regulations 

to reflect the withdrawal of approval of 

these NADAs. 

Dated: August 23, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–21295 Filed 8–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2010–0071] 

National Protection and Programs 

Directorate; Agency Information 

Collection Activities: Office of 

Infrastructure Protection; Chemical 

Security Awareness Training Program 

AGENCY: National Protection and 

Programs Directorate, DHS. 

ACTION: 60-Day notice and request for 

comments. 

Extension of a Currently Approved 

Information Collection: 1670–0009. 

SUMMARY: The Department of Homeland 

Security, National Protection and 

Programs Directorate, Office of 

Infrastructure Protection, SectorSpecific Agency Executive Management 

Office (NPPD/SSA EMO), submits the 

following Information Collection 

Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995 (Pub. L. 104–13, 44 U.S.C. Chapter 

35). 

DATES: Comments are encouraged and 

will be accepted until October 26, 2010. 

This process is conducted in accordance 

with 5 CFR 1320.1. 

ADDRESSES: Written comments and 

questions about this Information 

Collection Request should be forwarded 

to the Department of Homeland 

Security, NPPD/SSA EMO, Chemical 

Sector-Specific Agency, 245 Murray 

Lane, SW., Mail Stop 0608, Washington, 

DC 20528–0608. E-mailed requests 

should go to Amy Graydon at 

chemicalsector@dhs.gov. Written 

comments should reach the contact 

person listed no later than October 26, 

2010. Comments must be identified by 

DHS–2010–0071 and may be submitted 

by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. 

• E-mail: chemicalsector@dhs.gov. 

Include the docket number in the 

subject line of the message. 

Instructions: All submissions received 

must include the words ‘‘Department of 

Homeland Security’’ and the docket 

number for this action. Comments 

received will be posted without 

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

including any personal information 

provided. 

SUPPLEMENTARY INFORMATION: The 

Chemical Sector-Specific Agency, 

within the DHS NPPD/SSA EMO, 

provides an on-line voluntary training 

program to improve security in the 

chemical industry sector. Information is 

automatically collected in a computer 

database as a result of individuals 

engaging in the training. Explicit 

reporting or recordkeeping is not 

required. The training is designed for 

the general chemical facility employee. 

U.S. chemical industry direct 

employment is about 850,000 (2009 per 

the American Chemistry Council); 

approximately 400,000 employees are 

estimated as potential participants. 

Estimated duration in the first year to 

complete the registration, training, and 

survey is 60 minutes, and less if 

individuals take refresher training in 

succeeding years. Minimal participation 

data is collected as trainees complete 

the online exercises. Upon completion, 

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