59726 Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Innovative Strategies for 

Increasing Self-Sufficiency: Baseline 

Data Collection. 

OMB No.: 0970–0343. 

Billing Accounting Code (BAC): 

418409 (CAN G996121). 

Description: The Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), is proposing a data 

collection activity as part of the 

Innovative Strategies for Increasing SelfSufficiency (ISIS) demonstration and 

evaluation. The ISIS project will test a 

range of promising strategies to promote 

employment, self-sufficiency, and 

reduce dependence on cash welfare. 

The ISIS project will evaluate multiple 

employment-focused strategies that 

build on previous approaches and are 

adapted to the current Federal, State, 

and local policy environment. The 

major goals of the project include 

increasing the empirical knowledge 

about the effectiveness of a variety of 

programs for low-income families to 

sustain employment and advance to 

positions that enable self-sufficiency, as 

well as producing useful findings for 

both policymakers and program 

administrators. 

This proposed information collection 

activity focuses on collecting baseline 

data elements. Two data collection 

instruments will be completed by all 

participants prior to random 

assignment, and a third will be an 

interview guide to collect information 

from program staff. The first is a short 

baseline information form (BIF) that will 

collect basic identification, 

demographic, and contact information. 

The form will include relatively 

standard items from prior evaluations 

and national surveys. The second 

instrument will be a self-administered 

questionnaire (SAQ), covering 

information related to the project goals. 

The third instrument, baseline 

implementation data collection 

interviews, will be used to collect 

information from knowledgeable 

informants about the service context for 

each evaluation site using a baseline 

implementation guide. The purpose of 

such interviews is to document and 

assess the service environment in which 

the evaluation is implemented and the 

opportunities for control group 

members to access the same or similar 

services as the treatment group 

members. 

Respondents: Individuals enrolled in 

ISIS demonstration interventions, 

control group members, ISIS program 

operators (BIF and SAQ) and State and 

local informants (interviews). 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average burden hours per 

response 

Total annual 

burden hours 

Baseline Information Form .............................................................................. 4,800 1 0.75 3,600 

Self-Administered Questionnaire ..................................................................... 4800 1 0.75 3,600 

Baseline Implementation Data Collection Interviews ...................................... 30 1 1 30 

Estimated Total Annual Burden 

Hours: 7,230 

In compliance with the requirements 

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

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: OPRE Reports Clearance 

Officer. E-mail address: 

OPREinfocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments 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) 

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. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: September 21, 2010. 

Steven M. Hanmer, 

Reports Clearance Officer. 

[FR Doc. 2010–24122 Filed 9–27–10; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0428] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Herpes Simplex Virus Types 1 and 2 

Serological Assays; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological 

Assays.’’ This draft guidance document 

describes a means by which the herpes 

simplex virus (HSV) serological assay 

device type may comply with the 

requirement of special controls for class 

II devices. Elsewhere in this issue of the 

Federal Register, FDA is publishing a 

proposed rule to designate this guidance 

as the class II special control. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by December 27, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Herpes 

Simplex Virus Types 1 and 2 

Serological Assays’’ to the Division of 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 59727 

Small Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

draft guidance 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: Haja 

Sittana El Mubarak, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5519, Silver Spring, 

MD 20993–0002, 301–796–6193. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance document 

provides recommendations on the types 

of information and data that FDA 

believes needs to be included in a 

premarket notification 510(k) 

submission for HSV types 1 and 2 

serological assays. HSV serological 

assays are devices that consist of 

antigens and antisera used in various 

serological tests to identify antibodies to 

herpes simplex virus in serum. 

Additionally, some of the assays consist 

of herpes simplex virus antisera 

conjugated with a fluorescent dye 

(immunofluorescent assays) used to 

identify herpes simplex virus directly 

from clinical specimens or tissue 

culture isolates derived from clinical 

specimens. The identification aids in 

the diagnosis of diseases caused by 

herpes simplex viruses and provides 

epidemiological information on these 

diseases. Herpes simplex viral 

infections range from common and mild 

lesions of the skin and mucous 

membranes to a severe form of 

encephalitis (inflammation of the brain). 

Neonatal herpes virus infections range 

from a mild infection to a severe 

generalized disease with a fatal 

outcome. We have revised the existing 

guidance by rewriting the method 

comparison section and the sample 

selection inclusion and exclusion 

criteria section. The revisions defined 

and differentiated the required studies 

and the study populations for the 

assessment of the safety and 

effectiveness of the different types of 

HSV 1 and HSV 2 serological assays. 

Additionally, we made several 

corrections and clarifications 

throughout the document to ensure 

accuracy, consistency, and ease of 

reading. Elsewhere in this issue of the 

Federal Register, FDA is proposing to 

designate this guidance as the class II 

special control for HSV types 1 and 2 

serological assays. If this classification 

rule is finalized, FDA intends that this 

guidance document will serve as the 

special control for this device. 

Following the effective date of any 

final classification rule based on this 

proposal, any firm submitting a 

premarket notification (510(k)) for HSV 

types 1 and 2 serological assays will 

need to address the issues covered in 

the special controls guidance document. 

However, the firm need only show that 

its device meets the recommendations 

of the guidance document or in some 

other way provides equivalent 

assurances of safety and effectiveness. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on HSV types 1 and 2 serological assays. 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Class II Special 

Controls Guidance Document: Herpes 

Simplex Virus Types 1 and 2 

Serological Assays,’’ you may either 

send an email request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1713 to identify the guidance 

you are requesting. A search capability 

for all CDRH guidance documents is 

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

MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations 

and guidance documents. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 807, subpart E have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; and the collections 

of information in 21 CFR part 801 and 

21 CFR 809.10 have been approved 

under OMB control number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. 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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23640 Filed 9–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry (NCEH/ATSDR); 

Notice of National Conversation on 

Public Health and Chemical Exposures 

Leadership Council Meeting 

Time and Date: 9 a.m.—5 p.m. EDT, 

Tuesday, October 5, 2010. 

Location: Omni Shoreham Hotel, 2500 

Calvert Street NW., Washington, DC 

20008. 

Status: Open to the public, on a first 

come, first served basis, limited by the 

space available. An opportunity for the 

public to listen to the meeting by phone 

will be available. For information on 

observing the meeting in person or by 

phone, see ‘‘contact for additional 

information’’ below. 

Purpose: This is the sixth meeting of 

the National Conversation on Public 


srobinson on DSKHWCL6B1PROD with NOTICES