64956 Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 

Form title Number of

respondents 

Number of

responses/

respondent 

Average

burden per

response

(in hrs.) 

Supplementary Data Collection, Craniotomy Patient Report .................................................... 9 58 27/60 

Supplementary Data Collection, Spinal Fusion Patient Report ................................................ 18 60 27/60 

Supplementary Data Collection, Ventricular Shunt Patient ....................................................... 10 180 27/60 

AUR Surveillance Monthly Report: 

ICP ...................................................................................................................................... 30 12 (1×12) 2 

Laboratory Technician ........................................................................................................ 30 60 (5×12) 3 

Pharmacy Technician ......................................................................................................... 30 48 (4×12) 2 

AUR Surveillance Contact Information ...................................................................................... 40 1 10/60 

Antimicrobial Prescribing Practices ........................................................................................... 30 1 15/60 

Dated: November 3, 2004. 

B. Kathy Skipper, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention.

[FR Doc. 04–24892 Filed 11–8–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–05AD] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–498–1210 or send 

comments to Seleda Perryman, CDC 

Assistant Reports Clearance Officer, 

1600 Clifton Road, MS–E11, Atlanta, GA 

30333 or send an e-mail to 

omb@cdc.gov.

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Helping to End Lead Poisoning 

(HELP): A Questionnaire Study of 

Medicaid Providers’ Beliefs, Barriers, 

Knowledge, and Cues to Action for 

Childhood Blood Lead Testing—New—

National Center for Environmental 

Health (NCEH), Centers for Disease 

Control and Prevention (CDC). 

According to the United States 

Department of Health and Human 

Services (DHHS), lead poisoning is one 

of the most serious environmental 

threats to children in the United States. 

Very high blood lead levels in children 

can cause encephalopathy, coma, and 

even death. At lower levels, lead 

poisoning is a silent attacker because 

most children who are lead poisoned do 

not show symptoms. Low levels of lead 

poisoning are often associated with 

reductions in IQ and attention span, and 

with learning disabilities, hyperactivity, 

and behavioral problems. Because of 

these subtle effects, the best way to 

determine if a child has lead poisoning 

is by giving the child a blood lead test. 

Children eligible for Medicaid are 

typically at highest risk for lead 

exposure. DHHS policies require blood 

lead testing for all children participating 

in federal health care programs. 

However, most children in or targeted 

by federal health care programs have not 

been tested. This study will help to 

provide some of the reasons why most 

children are not being tested. 

Although blood lead testing is 

important, it is ineffective unless it is 

performed when the child is young 

enough to receive the full benefits of 

effective environmental interventions. 

Thus, it was determined by CDC that 

more information is needed to 

understand the barriers Medicaid 

providers face when it comes to blood 

lead testing. 

HELP is a comparison study between 

two communities in Wisconsin. To 

determine why some areas in Wisconsin 

have high blood lead testing rates and 

others do not, Medicaid providers in 

two areas will be studied. Community 1 

has high and Community 2 has low 

blood lead testing rates. Questionnaires 

will be mailed to all Medicaid providers 

in these two Wisconsin communities. 

The questionnaires will be mailed from 

the Wisconsin Childhood Lead 

Poisoning Prevention Program in 

Milwaukee, Wisconsin. CDC will 

analyze the data from the 

questionnaires. CDC and the Wisconsin 

Childhood Lead Poisoning Prevention 

Program staff will use this information 

to understand the barriers Medicaid 

providers face concerning blood lead 

testing and to develop effective 

strategies that promote blood lead 

testing among Medicaid providers. 

There are no costs to respondents except 

their time to participate.

ANNUALIZED BURDEN TABLE

Respondents Number of

respondents 

Number of

responses per

respondent 

Average

burden per

response

(in hrs.) 

Total

burden

hours 

Targeted Medicaid Providers in Wisconsin ..................................................... 500 1 10/60 83 

Total ................................................................................................................. ........................ ........................ ........................ 83 

Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 64957

Dated: November 3, 2004. 

B. Kathy Skipper, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention.

[FR Doc. 04–24893 Filed 11–8–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0480]

The Minor Use and Minor Species 

Animal Health Act; Request for 

Comments

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

establishment of a new Office of Minor 

Use and Minor Species (MUMS) Animal 

Drug Development and is requesting 

comments on the implementation of the 

newly enacted MUMS Animal Health 

Act. This notice is intended to provide 

the public with contact information for 

the new MUMS office as well as to 

provide a venue for public comment.

DATES: Submit written or electronic 

comments by January 10, 2005.

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to www.fda.gov/

dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Andrew Beaulieu, Office of Minor Use 

and Minor Species Animal Drug 

Development, Center for Veterinary 

Medicine, 7519 Standish Pl., Rockville, 

MD 20855, 301–827–2945, 

abeaulie@cvm.fda.gov. Alternatively, 

you may contact Margaret Oeller, Office 

of Minor Use and Minor Species Animal 

Drug Development, Center for 

Veterinary Medicine, 7519 Standish Pl., 

Rockville, MD 20855, 301–827–3067, 

moeller@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The MUMS Animal Health Act 

became law on August 2, 2004 (Public 

Law 108–282). Several elements of the 

law became immediately effective on 

that date. These include the provisions 

for designation of MUMS drugs under 

section 573 and for conditional approval 

of MUMS drugs under section 571. The 

indexing provisions under section 572 

of the law will only become effective 

upon publication of final implementing 

regulations. As mandated by the MUMS 

law, FDA has established the new Office 

of MUMS Animal Drug Development in 

the Center for Veterinary Medicine 

(CVM). FDA is requesting comments on 

any aspect of implementation of the 

MUMS legislation (see section II of this 

document). Requests for further 

information should be directed to the 

Office of MUMS Animal Drug 

Development (see FOR FURTHER

INFORMATION CONTACT).

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

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

Monday through Friday.

Dated: November 2, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24880 Filed 11–8–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0458]

Dietary Supplements; Strategy for the 

Further Implementation and 

Enforcement of the Dietary 

Supplement Health and Education Act 

of 1994; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of its strategy for the further 

implementation of the Dietary 

Supplement Health and Education Act 

of 1994 (DSHEA). The strategy sets forth 

a series of specific, integrated research 

and regulatory measures, including 

guidance, regulations, and sciencebased compliance and enforcement 

mechanisms. Through implementation 

of these measures, FDA hopes to 

improve the transparency, 

predictability, and consistency both of 

the agency’s scientific evaluations of 

dietary supplement product and 

ingredient safety, and of its regulatory 

actions to protect consumers against 

unsafe dietary supplements and dietary 

supplements making unauthorized, 

false, or misleading claims. FDA expects 

that this improved transparency will 

help engage stakeholders in the 

development of further measures to 

implement DSHEA.

DATES: Submit written or electronic 

comments at any time.

ADDRESSES: Submit written requests for 

single copies of the strategy for the 

further implementation of DSHEA to 

Vickey Lutwak, Center for Food Safety 

and Applied Nutrition (HFS–810), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1775, FAX: 301–436–2636, email: Vickey.Lutwak@fda.gov.

Submit written comments to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.fda.gov/dockets/

ecomments.

FOR FURTHER INFORMATION CONTACT:

Vickey Lutwak, Center for Food Safety 

and Applied Nutrition (HFS–810), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1775, FAX: 301–436–2636, email: Vickey.Lutwak@fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In January 2000, FDA’s Center for 

Food Safety and Applied Nutrition 

(CFSAN) issued its ‘‘Dietary 

Supplement Strategy: Ten Year Plan’’

(the 10-year plan) (accessible at http://

www.cfsan.fda.gov/~dms/ds-strat.html). 

The 10-year plan sets as a goal a 

science-based regulatory program that 

fully implements DSHEA and affords 

consumers a high level of confidence in 

the safety, composition, and labeling of 

dietary supplement products. The 10-

year plan sets forth a series of critical 

initiatives: (1) Improving the safety of 

products through, for example, 

regulations on current good 

manufacturing practice requirements for 

dietary supplements, guidance on 

premarket safety notifications for new 

dietary ingredients, and better adverse 

event report monitoring; (2) improving 

the labeling of products by, for example, 

clarifying what data and information are 

needed to substantiate structure/

function and related claims in the 

labeling of a product; (3) clarifying the 

boundaries between dietary 

supplements, conventional foods, and 

drugs; (4) taking enforcement action 

against unsafe products and products 

whose labels are inaccurate or