55482 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 

DATES: Meeting Date: October 17, 2006 

from 9 a.m. to 3:30 p.m., e.d.t. 

Deadline for Meeting Registration, 

Presentations, and Written Comments: 

October 10, 2006, 12 noon, e.d.t. 

ADDRESSES: Meeting Location: Marriott 

Metro Center Hotel, 775 12th Street, 

NW., Washington, DC 20005, (202) 737–

2200. 

Meeting Registration, Presentations, 

and Written Comments: Lynne Johnson, 

Health Insurance Specialist, Division of 

Partnership Development, Office of 

External Affairs, Centers for Medicare & 

Medicaid Services, 7500 Security 

Boulevard, Mail stop S1–05–06, 

Baltimore, MD 21244–1850 or contact 

Ms. Johnson via e-mail at 

Lynne.Johnson@cms.hhs.gov. 

Meeting Registration: The meeting is 

open to the public, but attendance is 

limited to the space available. Persons 

wishing to attend this meeting must 

register by contacting Lynne Johnson at 

the address listed in the ADDRESSES

section of this notice or by telephone at 

(410) 786–0090, by 12 noon, e.d.t., on 

October 10, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Lynne Johnson, (410) 786–0090. Please 

refer to the CMS Advisory Committees’

Information Line (1–877–449–5659 toll 

free)/(410–786–9379 local) or the 

Internet (http://www.cms.hhs.gov/ 

FACA/04_APME.asp) for additional 

information and updates on committee 

activities. Press inquiries are handled 

through the CMS Press Office at (202) 

690–6145. 

SUPPLEMENTARY INFORMATION: Section 

222 of the Public Health Service Act (42 

U.S.C. 217a), as amended, grants to the 

Secretary the authority to establish an 

advisory panel if the Secretary finds the 

panel necessary and in the public 

interest. The Secretary signed the 

charter establishing this Panel on 

January 21, 1999 and approved the 

renewal of the charter on January 14, 

2005. The establishment of the charter 

and renewal of the charter were 

announced in the February 17, 1999 

Federal Register (64 FR 7899), and the 

January 28, 2005 Federal Register (70 

FR 4129), respectively. The Panel 

advises and makes recommendations to 

the Secretary and the Administrator of 

the Centers for Medicare & Medicaid 

Services (CMS) on opportunities to 

enhance the effectiveness of consumer 

education strategies concerning the 

Medicare program. 

The goals of the Panel are as follows: 

• To develop and implement a 

national Medicare education program 

that describes the options for selecting 

a health plan under Medicare. 

• To enhance the Federal 

government’s effectiveness in informing 

the Medicare consumer, including the 

appropriate use of public-private 

partnerships. 

• To expand outreach to vulnerable 

and underserved communities, 

including racial and ethnic minorities, 

in the context of a national Medicare 

education program. 

• To assemble an information base of 

best practices for helping consumers 

evaluate health plan options and build 

a community infrastructure for 

information, counseling, and assistance. 

The current members of the Panel are: 

Anita B. Boles, Executive Director, 

Partnership for Clear Health 

Communications; Gwendolyn T. 

Bronson, SHINE/SHIP Counselor, 

Massachusetts SHINE Program; Dr. 

Yanira Cruz, President and Chief 

Executive Officer, National Hispanic 

Council on Aging; Clayton Fong, 

President and Chief Executive Officer, 

National Asian Pacific Center on Aging; 

Nan Kirsten-Forte, Executive Vice 

President, Consumer Services, WebMD; 

Dr. Jessie C. Gruman, President and 

Chief Executive Officer, Center for the 

Advancement of Health; Betty L. 

Kennard, Vice President, Government 

Programs and Compliance, Health First 

Health Plans; Dr. David Lansky, 

Director, Health Program, Markle 

Foundation; Dr. Daniel Lyons, Senior 

Vice President, Government Programs, 

Independence Blue Cross; Dr. Frank B. 

McArdle, Manager, Hewitt Research 

Office, Hewitt Associates; Traci 

McClellan, J.D., Executive Director, 

National Indian Council on Aging; Dr. 

Keith Mueller, Professor and Section 

Head, Health Services Research and 

Rural Health Policy, University of 

Nebraska; Lee Partridge, Senior Health 

Policy Advisor, National Partnership for 

Women and Families; Myisha M. 

Patterson, National Health Coordinator, 

National Association for the 

Advancement of Colored People; Susan 

O. Raetzman, Associate Director, Public 

Policy Institute, American Association 

of Retired Persons; Rebecca Snead, 

Administrative Manager, National 

Alliance of State Pharmacy Association; 

William A. Steel, President, The 

National Grange; Marvin Tuttle, Jr., 

CAE, Executive Director and Chief 

Executive Officer, Financial Planning 

Association; Catherine Valenti, 

Chairperson and Chief Executive 

Officer, Caring Voice Coalition; and 

Grant Wedner, Manager, Business 

Development Team, Cosmix 

Corporation. 

The agenda for the October 17, 2006 

meeting will include the following: 

• Recap of the previous (May 25, 

2006) meeting. 

• Centers for Medicare & Medicaid 

Services Update. 

• Medicare Preventive Benefits. 

• Medicare Prescription Drug Benefit 

Update. 

• Public Comment. 

• Listening Session with CMS 

Leadership. 

• Next Steps. 

Individuals or organizations that wish 

to make a 5-minute oral presentation on 

an agenda topic should submit a written 

copy of the oral presentation to Lynne 

Johnson at the address listed in the 

ADDRESSES section of this notice no later 

than 12 noon, e.d.t., on October 10, 

2006. The number of oral presentations 

may be limited by the time available. 

Individuals not wishing to make a 

presentation may submit written 

comments to Ms. Johnson at the address 

listed in the ADDRESSES section of this 

notice by 12 noon, e.d.t., on October 10, 

2006. 

Special Accommodation: Individuals 

requiring sign language interpretation or 

other special accommodations should 

contact Ms. Johnson at the address 

listed in the ADDRESSES section of this 

notice at least 15 days before the 

meeting. 

Authority: Sec. 222 of the Public Health 

Service Act (42 U.S.C. 217a) and sec. 10(a) 

of Public Law 92–463 (5 U.S.C. App. 2, sec. 

10(a) and 41 CFR 102–3). 

(Catalog of Federal Domestic Assistance 

Program No. 93.733, Medicare—Hospital 

Insurance Program; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 7, 2006. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 06–7884 Filed 9–21–06; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0180] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Records and 

Reports Concerning Experience With 

Approved New Animal Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 55483 

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 October 23, 

2006. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1472. 

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. 

Records and Reports Concerning 

Experience With Approved New 

Animal Drugs—21 CFR 518.80—(OMB 

Control No. 0910–0284)—Extension 

Implementation of section 512(l) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360b(l)) and § 514.80 (21 

CFR 514.80) requires applicants of 

approved new animal drug applications 

(NADAs) and abbreviated new animal 

drug applications (ANADAs) to submit 

product/manufacturing defects, initial 

and followup reports for adverse drug 

experiences and lack of effectiveness of 

new animal drugs, increased frequency 

15-day alert reports, periodic drug 

experience reports (annually or semiannually in a specific format), and other 

reports (special drug experience reports, 

advertisement and promotional material 

submissions, and distributor 

statements). 

This continuous monitoring of 

approved NADAs affords the primary 

means by which FDA obtains 

information regarding potential 

problems in safety and effectiveness of 

marketed animal drugs and potential 

manufacturing problems. Current data 

on file with FDA is not adequate 

because animal drug effects can change 

over time, and less apparent effects may 

take years to manifest themselves. 

Adverse reaction reports are required 

to be submitted by the drug 

manufacturer on FDA Forms 1932 or 

1932a (voluntary reporting form), 

following complaints from animal 

owners or veterinarians. Also, product 

defects and lack of effectiveness 

complaints are submitted to FDA by the 

drug manufacturer following their own 

detection of a problem or complaints 

from product users or their veterinarians 

using FDA forms 1932 and 1932a. Form 

FDA 2301 is used to submit the required 

transmittal of periodic reports and 

promotional material for new animal 

drugs. The reporting and recordkeeping 

burden estimates are based on the 

submission of reports to the Division of 

Surveillance, Center for Veterinary 

Medicine (CVM). The total annual 

responses are also based on the 

submission of reports to the Division of 

Surveillance, CVM. The annual 

frequency of response was calculated as 

the total annual responses divided by 

the number of respondents. 

In the Federal Register of May 19, 

2006 (71 FR 29157), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. In response to this notice, 

FDA received seven comments, four of 

which required a response by CVM that 

are addressed as follows: One comment 

stated that FDA’s estimate for the 

burden of the proposed collection of 

information seems unrealistic and 

inaccurate. The comment proposed 16 

hours of response time for Drug 

Experience Reports (DER), and 49 hours 

for recordkeeping for each DER. FDA 

agrees that 16 hours is a reasonable 

response time required to make a DER 

report. In view of increased reporting 

requirements under § 514.80 (b)(4), 

CVM has increased the ‘‘Hours per 

Response’’ under this citation in ‘‘Table 

1—Estimated Annual Reporting 

Burden,’’ from 11 to 16 hours thereby 

increasing the total burden hours to 

19,616. The comment also proposed 49 

hours response time per record for each 

DER. However, based on CVM’s 

experience and previous surveys of 

industry, the 49 hours of response per 

record for each DER is excessive. In 

view of increased requirements, under 

§ 514.80(e)3, CVM has increased the 

‘‘Hours per Record’’ under this citation 

in ‘‘Table 2—Estimated Annual 

Recordkeeping Burden,’’ from 10.35 to 

14 hours, thereby increasing the total 

burden hours to 33,320. 

Another comment suggested that the 

burden collections may be potentially 

reduced by: (1) Reducing submission 

requirements with established safety 

and (2) by automating the information 

collection system. FDA agrees with the 

comment regarding both suggestions. 

Under § 514.80(b)(4), it states for yearly 

periodic DER reports, an applicant may 

petition FDA to change the anniversary 

date and/or change the frequency of 

reporting. Regarding the comment 

suggesting automation of the 

information collection system, future 

burden estimates for collections of 

information will be considered when 

automated reporting requirements are 

implemented by FDA. 

Another comment wanted to know 

the purpose for submitting a periodic 

report for a known event for a product 

with an established record. As 

previously stated, under § 514.80(b)(4), 

an applicant may petition FDA to 

change the anniversary date and/or 

change the frequency of reporting. 

The respondents to this collection of 

information are applicants of approved 

NADAs and ANADAs. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section FDA Form 

No. 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

514.80(b)(1) 1932 190 0.50 95 1 95 

514.80(b)(2)(i) 1932 190 64.65 12,283 1 12,283 

514.80(b)(2)(ii) 1932 190 31.62 6,007 1 6,007 

514.80(b)(3) 1932 340 2.94 1,000 1 1,000 

Voluntary reporting 

FDA Form 1932a 

for public 1923a 250 1 250 1 250 


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55484 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section FDA Form 

No. 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

514.80(b)(4) 2301 190 6.45 1,226 16 19,616 

514.80(b)(5)(i) 2301 190 0.13 25 2 50 

514.80(b)(5)(ii) 2301 190 4.06 772 2 1544 

514.80(b)(5)(iii) 2301 530 0.11 56 2 112 

Total Hours 40,957 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping Total Annual Records Hours per Record Total Hours 

514.80(e)2 530 36.58 19,385 0.5 9,693 

514.80(e)3 530 4.49 2,379 14 33,320 

Total 43,013 

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

2Recordkeeping estimates for § 514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3); Form FDA 1932. 3Recordkeeping estimates for § 514.80(b)(2)(iii), (b)(4), (b)(5), and (c); Form FDA 2301. 

The reporting and recordkeeping 

burden estimates for this collection of 

information are based on the submission 

of reports to the Division of 

Surveillance, CVM. The total annual 

response numbers are also based on the 

submission of reports to the Division of 

Surveillance, CVM. The annual 

frequency of response was calculated as 

the total annual responses divided by 

the number of respondents. 

Dated: September 15, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8023 Filed 9–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0105] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Environmental 

Impact Considerations 

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 October 23, 

2006. 

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. 

FOR FURTHER INFORMATION CONTACT: Liz 

Berbakos, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482. 

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. 

Environmental Impact 

Considerations—(OMB Control Number 

0910–0322)—Extension 

FDA is requesting OMB approval for 

the reporting requirements contained in 

the FDA regulation ‘‘Environmental 

Impact Considerations.’’

The National Environmental Policy 

Act (NEPA) (42 U.S.C. 4321–4347), 

states national environmental objectives 

and imposes upon each Federal agency 

the duty to consider the environmental 

effects of its actions. Section 102(2)(C) 

of NEPA requires the preparation of an 

environmental impact statement (EIS) 

for every major Federal action that will 

significantly affect the quality of the 

human environment. 

The FDA NEPA regulations are in part 

25 (21 CFR part 25). All applications or 

petitions requesting agency action 

require the submission of a claim for a 

categorical exclusion or an 

environmental assessment (EA). A 

categorical exclusion applies to certain 

classes of FDA-regulated actions that 

usually have little or no potential to 

cause significant environmental effects 

and are excluded from the requirements 

to prepare an EA or EIS. Section 

25.15(a) and (d) specifies the procedures 

for submitting to FDA a claim for a 

categorical exclusion. Extraordinary 

circumstances (§ 25.21), which may 

result in significant environmental 

impacts, may exist for some actions that 

are usually categorically excluded. An 

EA provides information that is used to 

determine whether an FDA action could 

result in a significant environmental 

impact. Section 25.40(a) and (c) 

specifies the content requirements for 

EAs for nonexcluded actions. 

This collection of information is used 

by FDA to assess the environmental 

impact of agency actions and to ensure 

that the public is informed of 

environmental analyses. Firms wishing 

to manufacture and market substances 

regulated under statutes for which FDA 

is responsible must, in most instances, 

submit applications requesting 

approval. Environmental information 

must be included in such applications 

for the purpose of determining whether 

the proposed action may have a 

significant impact on the environment. 

Where significant adverse effects cannot 

be avoided, the agency uses the 

submitted information as the basis for 

preparing and circulating to the public 


sroberts on PROD1PC70 with NOTICES