50736 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices 

Dated: August 8, 2011. 

Judith Sparrow, 

Office of Programs and Coordination, Office 

of the National Coordinator for Health 

Information Technology. 

[FR Doc. 2011–20811 Filed 8–15–11; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

HIT Standards Committee’s Workgroup 

Meetings; Notice of Meetings 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology, HHS. 

ACTION: Notice of meetings. 

This notice announces forthcoming 

subcommittee meetings of a federal 

advisory committee of the Office of the 

National Coordinator for Health 

Information Technology (ONC). The 

meetings will be open to the public via 

dial-in access only. 

Name of Committees: HIT Standards 

Committee’s Workgroups: Clinical 

Operations, Vocabulary Task Force, 

Clinical Quality, Implementation, and 

Privacy & Security Standards 

workgroups. 

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 HIT Standards 

Committee Workgroups will hold the 

following public meetings during 

September 2011: September 22nd 

Implementation Workgroup, 3 to 5 p.m./ 

ET; TBD other Workgroups’ calls. 

Location: All workgroup meetings 

will be available via Webcast; visit 

http://healthit.hhs.gov for instructions 

on how to listen via telephone or Web. 

Please check the ONC Web site for 

additional information and schedules as 

it becomes available. 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 these meetings. A notice 

in the Federal Register about last 

minute modifications that affect a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. 

Agenda: The workgroups will be 

discussing issues related to their 

specific subject matter, e.g., clinical 

operations, vocabulary standards, 

clinical quality, implementation 

opportunities and challenges, and 

privacy and security standards 

activities. If background materials are 

associated with the workgroup 

meetings, they will be posted on ONC’s 

Web site prior to 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 workgroups. Written 

submissions may be made to the contact 

person on or before two days prior to 

the workgroups’ meeting dates. Oral 

comments from the public will be 

scheduled at the conclusion of each 

workgroup meeting. Time allotted for 

each presentation will be limited to 

three minutes. If the number of speakers 

requesting to comment is greater than 

can be reasonably accommodated 

during the scheduled open public 

session, ONC will take written 

comments after the meeting until close 

of business on that day. 

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: August 8, 2011. 

Judith Sparrow, 

Office of Programs and Coordination, Office 

of the National Coordinator for Health 

Information Technology. 

[FR Doc. 2011–20815 Filed 8–15–11; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0555] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Extra Label Drug 

Use in Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the reporting requirements associated 

with extra label drug use in animals. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 17, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

Juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices 50737 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Extra Label Drug Use in Animals—21 

CFR Part 530 (OMB Control Number 

0910–0325—Extension) 

The Animal Medicinal Drug Use 

Clarification Act of 1994 allows a 

veterinarian to prescribe the extra-label 

use of approved new animal drugs. 

Also, it permits FDA, if it finds that 

there is a reasonable probability that the 

extra-label use of an animal drug may 

present a risk to the public health, to 

establish a safe level for a residue from 

the extra-label use of the drug, and to 

require the development of an analytical 

method for the detection of residues 

above that established safe level. 

Although to date, we have not 

established a safe level for a residue 

from the extra-label use of any new 

animal drug, and therefore, have not 

required the development of analytical 

methodology, we believe that there may 

be instances when analytical 

methodology will be required. We are 

therefore estimating the reporting 

burden based on two methods being 

required annually. The requirement to 

establish an analytical method may be 

fulfilled by any interested person. We 

believe that the sponsor of the drug will 

be willing to develop the method in 

most cases. Alternatively, FDA, the 

sponsor, and perhaps a third party may 

cooperatively arrange for method 

development. The respondents may be 

sponsors of new animal drugs, State, or 

Federal and/or State Agencies, 

academia, or individuals. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

530.22(b) .......................................................... 2 1 2 4,160 8,320 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: August 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20813 Filed 8–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0568] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study: Disease Information in Branded 

Promotional Material 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

research entitled ‘‘Experimental Study: 

Disease Information in Branded 

Promotional Material.’’ The proposed 

research will explore the nature of 

including information about a disease 

and promotional information about a 

specific drug treatment in the same 

advertising piece. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 17, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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., 

P150–400B, Rockville, MD 20850, 301– 

796–3972, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Experimental Study: Disease 

Information in Branded Promotional 

Material—(OMB Control Number 0910– 

New) 

Regulatory Background: Section 

1701(a)(4) of the Public Health Service 


emcdonald on DSK2BSOYB1PROD with NOTICES