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 


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