Federal Register / Vol. 75, No. 105 / Wednesday, June 2, 2010 / Notices 30837 

ANNUALIZED SUMMARY TABLE—Continued 

Respondents Number of 

respondents 

Responses/ 

respondent 

Total 

responses 

Total 

annualized 

hour burden 

Campus Staff ................................................................................................... 152 7 152 206 

Total .......................................................................................................... 132,060 49 133,890 26,444 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by July 2, 2010 to: SAMHSA 

Desk Officer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503; due to potential delays in OMB’s 

receipt and processing of mail sent 

through the U.S. Postal Service, 

respondents are encouraged to submit 

comments by fax to: 202–395–6974. 

Dated: May 25, 2010. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. 2010–13146 Filed 6–1–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

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

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration will publish 

periodic summaries of proposed 

projects. To request more information 

on the proposed projects or to obtain a 

copy of the information collection 

plans, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are 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. 

Proposed Project: Screening, Brief 

Intervention, Brief Treatment and 

Referral to Treatment (SBIRT) CrossSite Evaluation—New 

SAMHSA is conducting a cross-site 

external evaluation of the impact of 

programs of screening, brief 

intervention (BI), brief treatment (BT) 

and referral to treatment on patients 

presenting at various health care 

delivery units with a continuum of 

severity of substance use. SAMHSA’s 

SBIRT program is a cooperative 

agreement grant program designed to 

help States and Tribal Councils expand 

the continuum of care available for 

substance misuse and use disorders. 

The program includes screening, brief 

intervention, brief treatment and 

referrals to treatment for persons at risk 

for dependence on alcohol or drugs. The 

cross-site evaluation will provide a 

comprehensive assessment of the effects 

of SBIRT on patient outcomes, 

performance site practices, and 

treatment systems. This information 

will allow SAMHSA to determine the 

extent to which SBIRT has met its 

objectives of implementing a 

comprehensive system of identification 

and care to meet the needs of 

individuals at all points along the 

substance use continuum. 

A paper and pencil survey will be 

administered to practitioners in sites 

where SBIRT services are being 

delivered. The practitioner survey is 

designed to evaluate the 

implementation of proposed SBIRT 

models by measuring their penetration 

and practitioners’ willingness to adopt. 

Furthermore, the survey will document 

moderating factors related to 

practitioner and health care delivery 

unit characteristics. 

The 93 question practitioner survey 

includes collection of demographic 

information as well as questions that 

attempt to assess barriers to 

implementation encountered by the 

practitioners and to gauge the 

effectiveness of the training they 

received. These measures were 

developed and used by Babor et al. 

(2005) in their comparable study 

comparing different implementation 

strategies for primary care screening and 

brief intervention programs for 

hazardous and harmful drinkers. The 

practitioner survey also includes an 

instrument developed by Panzano and 

Roth (2006) to measures an 

organization’s willingness to adopt new 

innovative practices. 

TOTAL BURDEN HOURS FOR THE CROSS-SITE PATIENT SURVEY

Instrument/Activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Total burden 

hours Hourly wage 

Total 

respondent 

cost a

Practitioner Survey ................................... 1,075 1 .30 322.5 $32 $10,320 


sroberts on DSKD5P82C1PROD with NOTICES
30838 Federal Register / Vol. 75, No. 105 / Wednesday, June 2, 2010 / Notices 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: May 25, 2010. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. 2010–13145 Filed 6–1–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2003–N–0196] (formerly 

Docket No. 2003N–0233) 

Drometrizole Trisiloxane Eligibility for 

Potential Inclusion in Sunscreen 

Monograph; Over-the-Counter 

Sunscreen Drug Products for Human 

Use; Request for Safety, Effectiveness, 

and Environmental Data 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of eligibility; request for 

data and information. 

SUMMARY: As part of our ongoing review 

of over-the-counter (OTC) drug 

products, we (Food and Drug 

Administration, FDA) are announcing a 

call-for-data for safety, effectiveness, 

and environmental information for 

drometrizole trisiloxane, in 

concentrations up to 15 percent, as a 

sunscreen single active ingredient and 

in combination with generally 

recognized as safe and effective 

(GRASE) sunscreen active ingredients 

found in the sunscreen monograph. We 

reviewed a time and extent application 

(TEA) for drometrizole trisiloxane and 

determined that it is eligible to be 

considered for inclusion in our OTC 

drug monograph system. We will 

evaluate the submitted safety and 

effectiveness data and information to 

determine whether drometrizole 

trisiloxane can be GRASE for its 

proposed OTC use. We also request data 

and information to assess the projected 

environmental effects of a potential 

GRASE determination in order to assist 

us in complying with the requirements 

of the National Environmental Policy 

Act of 1969 (NEPA). 

DATES: Submit data, information, and 

general comments by August 31, 2010. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2003–N– 

0196, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the agency name and 

docket number. All comments received 

may be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Anita Kumar, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5445, 

Silver Spring, MD 20993, 301–796– 

2090. 

SUPPLEMENTARY INFORMATION: 

I. Eligibility of Drometrizole Trisiloxane 

In January 2009, we received a TEA 

(Ref. 1) requesting that drometrizole 

trisiloxane be found eligible for review 

and potential inclusion in our OTC 

sunscreen drug monograph (part 352 (21 

CFR part 352)). After reviewing the 

TEA, we believe that it includes 

adequate data demonstrating that 

drometrizole trisiloxane has been 

marketed for the prevention of sunburn 

for a material time and to a material 

extent as required by § 330.14 (21 CFR 

330.14) (Ref. 2). Drometrizole 

trisiloxane-containing sunscreen 

products indicated for the prevention of 

sunburn have been marketed directly to 

consumers for over 5 continuous years 

in 40 countries, with over 177 million 

dosage units marketed in 54 countries. 

Therefore, we conclude that 

drometrizole trisiloxane, in 

concentrations up to 15 percent, is 

eligible to be considered for potential 

inclusion in the OTC sunscreen drug 

monograph as a single active ingredient 

and in combination with GRASE 

sunscreen active ingredients found in 

§ 352.10. 

II. Request for Data and Information 

We invite all interested persons to 

submit data and information, as 

described in § 330.14(f), on the safety 

and effectiveness of drometrizole 

trisiloxane for use as an active 

ingredient in OTC sunscreen products. 

The data should be sufficient so that we 

can determine whether the ingredient 

can be GRASE and not misbranded 

under recommended conditions of OTC 

use. Interested parties may refer to 21 

CFR 330.10(a)(4) regarding the evidence 

necessary for establishing general 

recognition of safety and effectiveness. 

Because the TEA that we reviewed 

did not include an official or proposed 

United States Pharmacopeia-National 

Formulary (USP–NF) drug monograph 

for drometrizole trisiloxane, we are 

asking interested parties to provide such 

a monograph to us. An active ingredient 

must be recognized in an official USP– 

NF drug monograph that sets forth its 

standards of identity, strength, quality, 

and purity in order to be included in a 

final OTC monograph (§ 330.14(i)). 

In addition, as stated in 21 CFR 25.1, 

FDA regulations must comply with 

NEPA. To comply with NEPA, an 

environmental assessment (EA) of 

agency actions is required unless we 

determine that a categorical exclusion is 

warranted. Therefore, we also invite all 

interested persons to either submit data 

and information that would support a 

determination that the potential 

inclusion of drometrizole trisiloxane in 

the OTC monograph for sunscreen 

meets the requirements for any 

categorical exclusion found in 21 CFR 

25.31, or to prepare an EA, if necessary. 

For additional information on the types 

of information that would support our 

environmental assessment, please refer 

to section IV (pages 9 through 27) of the 

Center for Drug Evaluation and Research 

Guidance on Environmental Assessment 

of Human Drug and Biologic 

Applications. The guidance document 

can be viewed at http://www.fda.gov/ 

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

ucm070561.pdf. 

For all data and information 

submitted, we request that a submitter 

segregate any data or information that 

the submitter believes is protected from 

disclosure by 5 U.S.C. 552(b), 18 U.S.C. 

1905, or 21 U.S.C. 331(j) or 360j(c). If 

such data or information is included in 

the submission, we request that the 

submitter summarize the confidential 

information, to the extent possible, so 

that the summary can be publicly 

disclosed (see 21 CFR 25.50 and 

25.51(a); § 330.14(f)). 


sroberts on DSKD5P82C1PROD with NOTICES