Federal Register / Vol. 75, No. 206 / Tuesday, October 26, 2010 / Notices 65635 

ESTIMATED ANNUALIZED BURDEN HOURS

Forms Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Program progress report—Full biannual report with 7 modules.State government or Qualified State 

Designated Entity.

56 2 12 1,344 

Program progress report—Partial 

progress report update on interim 

quarters with 2 modules.

State government or Qualified State 

Designated Entity.

56 2 3 336 

Total ........................................... .......................................................... ........................ ........................ ........................ 1,680 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Clearance Officer. 

[FR Doc. 2010–26956 Filed 10–25–10; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–NEW; 

30-day notice] 

Agency Information Collection 

Request 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed collection for public 

comment. Interested persons are invited 

to send comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, e-mail your request, 

including your address, phone number, 

OMB number, and OS document 

identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–5683. Send written comments and 

recommendations for the proposed 

information collections within 30 days 

of this notice directly to the OS OMB 

Desk Officer; faxed to OMB at 202–395– 

5806. 

Proposed Project: ONC State HIE State 

Plans—OMB No. 0990—Existing 

collection in use without OMB control 

number—Office of the National 

Coordinator for Health Information 

Technology (ONC). 

Abstract: The purpose of the State 

Health Information Exchange 

Cooperative Agreement Program, as 

authorized by Section 3013 of the 

American Recovery and Reinvestment 

Act is to provide grants to States and 

Qualified State Designated Entities is to 

facilitate and expand the secure, 

electronic movement and use of health 

information among organizations 

according to national recognized 

standards. Section 3013 requires States 

and Qualified State Designated Entities 

to have approved State Plans, consisting 

of strategic and operational components, 

before funding can be used for 

implementation activities. The State 

Plans must be submitted to the National 

Coordinator for Health Information 

Technology during the first year of the 

project period in order to receive 

implementation funding through the 

cooperative agreement. Annual updates 

to the State plans will be required in the 

three remaining project periods. The 

data collection will last four years, 

which is the duration of the project, and 

this request is for the data collection for 

the first three years of that project 

period. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Form name Number of 

respondents 

Number 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

State government or Qualified 

State Designated Entity.

State Plans (Strategic and Operational).56 1 3,341 .3 187,112 .8 

State government or Qualified 

State Designated Entity.

Subsequent updates to the State 

Plan.

56 1 500 28,000 

Total ......................................... ......................................................... ........................ ........................ .......................... 215,114 .6 


emcdonald on DSK2BSOYB1PROD with NOTICES
65636 Federal Register / Vol. 75, No. 206 / Tuesday, October 26, 2010 / Notices 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Clearance Officer. 

[FR Doc. 2010–26955 Filed 10–25–10; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; HIT 

Standards Committee Advisory 

Meeting; Notice of Meeting 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology, HHS. 

ACTION: Notice of meeting. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Office of the National Coordinator 

for Health Information Technology 

(ONC). The meeting will be open to the 

public. 

Name of Committee: HIT Standards 

Committee. 

General Function of the Committee: 

To provide recommendations to the 

National Coordinator on standards, 

implementation specifications, and 

certification criteria for the electronic 

exchange and use of health information 

for purposes of adoption, consistent 

with the implementation of the Federal 

Health IT Strategic Plan, and in 

accordance with policies developed by 

the HIT Policy Committee. 

Date and Time: The meeting will be 

held on November 30, 2010, from 9 a.m. 

to 3 p.m./Eastern Time. 

Location: The meeting will be 

conducted virtually only. Dial into the 

meeting: 1–877–705–6006; webcast: 

http://altarum.adobeconnect.com/ 

HITstandards. 

Contact Person: Judy Sparrow, Office 

of the National Coordinator, HHS, 330 C 

Street, SW., Washington, DC 20201, 

202–205–4528, Fax: 202–690–6079, 

e-mail: judy.sparrow@hhs.gov. Please 

call the contact person for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Agenda: The committee will hear 

reports from its workgroups, including 

the Clinical Operations, Vocabulary 

Task Force, Implementation, and 

Enrollment Workgroups. ONC intends 

to make background material available 

to the public no later than two (2) 

business days prior to the meeting. If 

ONC is unable to post the background 

material on its Web site prior to the 

meeting, it will be made publicly 

available at the location of the advisory 

committee meeting, and the background 

material will be posted on ONC’s Web 

site after the meeting, at http:// 

healthit.hhs.gov. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before November 24, 2010. 

Oral comments from the public will be 

scheduled between approximately 2 and 

3 p.m./Eastern Time. Time allotted for 

each presentation will be limited to 

three minutes each. If the number of 

speakers requesting to comment is 

greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, ONC will 

take written comments after the meeting 

until close of business. 

Persons attending ONC’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

ONC welcomes the attendance of the 

public at its advisory committee 

meetings. Seating is limited at the 

location, and ONC will make every 

effort to accommodate persons with 

physical disabilities or special needs. If 

you require special accommodations 

due to a disability, please contact Judy 

Sparrow at least seven (7) days in 

advance of the meeting. 

ONC is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://healthit.hhs.gov for procedures 

on public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(Pub. L. 92–463, 5 U.S.C., App. 2). 

Dated: October 18, 2010. 

Judith Sparrow, 

Office of Programs and Coordination, Office 

of the National Coordinator for Health 

Information Technology. 

[FR Doc. 2010–26918 Filed 10–25–10; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0541] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Special Protocol 

Assessment 

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 November 

26, 2010. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0470. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.berbakos@fda.hhs.gov. 

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. 

Guidance for Industry on Special 

Protocol Assessment—OMB Control 

Number 0910–0470—Extension 

The ‘‘Guidance for Industry on Special 

Protocol Assessment’’ describes Agency 

procedures to evaluate issues related to 

the adequacy (e.g., design, conduct, 

analysis) of certain proposed studies. 

The guidance describes procedures for 

sponsors to request special protocol 

assessment and for the Agency to act on 

such requests. The guidance provides 

information on how the Agency 

interprets and applies provisions of the 

Food and Drug Administration 


emcdonald on DSK2BSOYB1PROD with NOTICES