Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices 53505 

ESTIMATED ANNUALIZED BURDEN TABLE

Forms Type of respondent Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Interview Protocol ............................. Faculty .............................................. 100 1 2 200 

Interview Protocol ............................. Doctoral Student Graduates ............ 100 1 2 200 

Total ........................................... ........................................................... ........................ ........................ ........................ 400 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E9–25028 Filed 10–16–09; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; HIT 

Standards Committee’s 

Implementation Workgroup 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 

subcommittee 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’s Implementation 

Workgroup. 

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. The 

Implementation Workgroup is charged 

with benchmarking adoption rates for 

proposed standards across diverse 

settings; soliciting public input on what 

stakeholders need to lower the barriers 

to standards adoption; evaluating the 

degree to which proposed standards 

achieve policy objectives; and 

establishing an ongoing process to 

gather public input to inform future 

standards development, revisions to 

existing standards, or guidance on tools 

to minimize the cost of adoption. 

Date and Time: The meeting will be 

held on October 29, 2009, from 9 a.m. 

to 3 p.m./Eastern Time. 

Location: The Omni Shoreham Hotel, 

2500 Calvert Street, NW., Washington, 

DC. The hotel telephone number is 202– 

234–0700. 

Contact Person: Judy Sparrow, Office 

of the National Coordinator, HHS, 330 C 

Street, SW., Washington, DC 20201, 

202–205–4528, Fax: 202–690–6079, email: 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 Implementation 

Workgroup will be hearing testimony 

from stakeholder groups, such as 

purchasers, vendors, and users, on 

health information technology adoption 

experiences with the proposed 

standards. The Workgroup intends to 

monitor the adoption rate of proposed 

standards, identify opportunities to 

accelerate implementation, and 

establish a continuous feedback loop on 

the development of new or revised 

standards. 

In addition to soliciting verbal and 

formal written comments at the hearing, 

the Workgroup will use a Web-based 

tool to engage the public. The ONC is 

setting up a Web-based tool to engage 

the public in the topic; please visit the 

ONC Web site closer to the meeting date 

for additional information. 

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 subcommittee meeting, and the 

background material will be posted on 

ONC’s Web site after the meeting, at 

http://healthit.hhs.gov. The meeting 

will be available via Webcast; visit 

http://healthit.hhs.gov for instructions 

on how to listen via telephone or Web. 

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 from October 29th until 

November 12, 2009. Oral comments 

from the pubic will be scheduled at the 

close of the meeting on October 29, 

2009. Time allotted for each 

presentation may be limited. 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 on 

that day. 

Persons attending 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 13, 2009. 

Judith Sparrow, 

Office of Programs and Coordination, Office 

of the National Coordinator for Health 

Information Technology. 

[FR Doc. E9–25051 Filed 10–14–09; 4:15 pm] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Solicitation for Members of the 

National Vaccine Advisory Committee 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of Public Health and Science. 

ACTION: Notice. 

Authority: 42 U.S.C. 300aa–5, Section 

2105 of the Public Health Service (PHS) 


sroberts on DSKD5P82C1PROD with NOTICES
53506 Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices 

Act, as amended. The Committee is 

governed by the provisions of Public 

Law 92–463, as amended (5 U.S.C. 

Appendix 2), which sets forth standards 

for the formation and use of advisory 

committees. 

SUMMARY: The National Vaccine 

Program Office (NVPO), a program 

office within the Office of Public Health 

and Science, DHHS, is soliciting 

nominations of qualified candidates to 

be considered for appointment as public 

members to the National Vaccine 

Advisory Committee (NVAC). The 

activities of this Committee are 

governed by the Federal Advisory 

Committee Act (FACA). Management 

support for the activities of this 

Committee is the responsibility of the 

NVPO. 

Consistent with the National Vaccine 

Plan, the Committee advises and makes 

recommendations to the Assistant 

Secretary for Health in his capacity as 

the Director of the National Vaccine 

Program, on matters related to the 

Program’s responsibilities. Specifically, 

the Committee studies and recommends 

ways to encourage the availability of an 

adequate supply of safe and effective 

vaccination products in the United 

States; recommends research priorities 

and other measures to enhance the 

safety and efficacy of vaccines. The 

Committee also advises the Assistant 

Secretary for Health in the 

implementation of Sections 2102 and 

2103 of the PHS Act; and identifies 

annually the most important areas of 

government and non-government 

cooperation that should be considered 

in implementing Sections 2102 and 

2103 of the PHS Act. 

DATES: Nominations for membership on 

the Committee must be received no later 

than 5 p.m. EDT on November 16, 2009, 

at the address below. 

ADDRESSES: All nominations should be 

mailed or delivered to: Bruce G. Gellin, 

M.D., M.P.H., Executive Secretary, 

NVAC, Office of Public Health and 

Science, Department of Health and 

Human Services, 200 Independence 

Avenue, SW., Room 715–H, Hubert H. 

Humphrey Building, Washington, DC 

20201. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Andrea Krull, Public Health Advisor, 

National Vaccine Program Office, 

Department of Health and Human 

Services, 200 Independence Avenue, 

SW., Room 715–H, Hubert H. Humphrey 

Building, Washington, DC 20201; (202) 

690–5566; nvpo@hhs.gov. 

A copy of the Committee charter 

which includes the Committee’s 

structure and functions as well as a list 

of the current membership can be 

obtained by contacting Ms. Krull or by 

accessing the NVAC Web site at: 

www.hhs.gov/nvpo/nvac. 

SUPPLEMENTARY INFORMATION: 

Committee Function, Qualifications, 

and Information Required: As part of an 

ongoing effort to enhance deliberations 

and discussions with the public on 

vaccine and immunization policy, 

nominations are being sought for 

interested individuals to serve on the 

Committee as public members. 

Individuals selected for appointment to 

the Committee will serve as voting 

members. The Committee is composed 

of 15 public members, including the 

Chair, and two representative members. 

In accordance with the Committee 

charter, public members shall be 

selected from individuals who are 

engaged in vaccine research or the 

manufacture of vaccines, or who are 

physicians, members of parent 

organizations concerned with 

immunizations, representatives of state 

or local health agencies or public health 

organizations. Representative members 

shall be selected from the vaccine 

manufacturing industry who are 

engaged in vaccine research or the 

manufacture of vaccines. Individuals 

selected for appointment to the 

Committee can be invited to serve terms 

of up to four years. 

All NVAC members are authorized to 

receive the prescribed per diem 

allowance and reimbursement for travel 

expenses that are incurred to attend 

meetings and conduct authorized 

Committee-related business, in 

accordance with Standard Government 

Travel Regulations. Individuals who are 

appointed to serve as public members 

are authorized also to receive 

honorarium for attending Committee 

meetings and to carry out other 

authorized Committee-related business. 

Individuals who are appointed to serve 

as representative members for a 

particular interest group or industry are 

not authorized to receive honorarium 

for the performance of these duties. 

This announcement is to solicit 

nominations of qualified candidates to 

fill positions on the NVAC that are 

scheduled to be vacated in the public 

member category. The positions are 

scheduled to be vacated on March 31, 

2010. 

Nominations 

In accordance with the charter, 

persons nominated for appointment as 

members of the NVAC should be among 

authorities knowledgeable in areas 

related to vaccine safety, vaccine 

effectiveness, and vaccine supply. 

Nominations should be typewritten. The 

following information should be 

included in the package of material 

submitted for each individual being 

nominated for consideration: (1) A letter 

of nomination that clearly states the 

name and affiliation of the nominee, the 

basis for the nomination (i.e., specific 

attributes which qualify the nominee for 

service in this capacity), and a statement 

that the nominee is willing to serve as 

a member of the Committee; (2) the 

nominator’s name, address and daytime 

telephone number, and the home and/ 

or work address, telephone number, and 

e-mail address of the individual being 

nominated; and (3) a current copy of the 

nominee’s curriculum vitae. 

Individuals can nominate themselves 

for consideration of appointment to the 

Committee. All nominations must 

include the required information. 

Incomplete nominations will not be 

processed for consideration. The letter 

from the nominator and certification of 

the nominated individual must bear 

original signatures; reproduced copies 

of these signatures are not acceptable. 

Applications cannot be submitted by 

facsimile. The names of Federal 

employees should not be nominated for 

consideration of appointment to this 

Committee. 

The Department makes every effort to 

ensure that the membership of HHS 

Federal advisory committees is fairly 

balanced in terms of points of view 

represented and the committee’s 

function. Every effort is made that a 

broad representation of geographic 

areas, gender, ethnic and minority 

groups, and the disabled are given 

consideration for membership on HHS 

Federal advisory committees. 

Appointment to this committee shall be 

made without discrimination on the 

basis of age, race, ethnicity, gender, 

sexual orientation, disability, and 

cultural, religious, or socioeconomic 

status. 

The Standards of Ethical Conduct for 

Employees of the Executive Branch are 

applicable to individuals who are 

appointed as public members of Federal 

advisory committees. Individuals 

appointed to serve as public members of 

Federal advisory committees are 

classified as special Government 

employees (SGEs). SGEs are 

Government employees for purposes of 

the conflict of interest laws. Therefore, 

individuals appointed to serve as public 

members of NVAC are subject to an 

ethics review. The ethics review is 

conducted to determine if the 

individual has any interests and/or 

activities in the private sector that may 

conflict with performance of their 

official duties as a member of the 

Committee. Individuals appointed to 

serve as public members of the 


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Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices 53507 

1See ‘‘Requirements on Content and Format of 

Labeling for Human Prescription Drug and 

Biological Products’’ (71 FR 3922, January 24, 2006; 

21 CFR parts 201, 314, 601). 2See § 201.57(a)(6). 

Committee will be required to disclose 

information regarding financial 

holdings, consultancies, and research 

grants and/or contracts. 

Dated: October 6, 2009. 

Bruce Gellin, 

Director, National Vaccine Program Office, 

Executive Secretary, National Vaccine 

Advisory Committee. 

[FR Doc. E9–25079 Filed 10–16–09; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0302] (formerly 

Docket No. 2007D–0185) 

Guidance for Industry and Review Staff 

on Labeling for Human Prescription 

Drug and Biological Products— 

Determining Established 

Pharmacologic Class for Use in the 

Highlights of Prescribing Information; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

and review staff entitled ‘‘Labeling for 

Human Prescription Drug and Biological 

Products—Determining Established 

Pharmacologic Class for Use in the 

Highlights of Prescribing Information.’’ 

This guidance is intended to provide 

applicants and review staff with a 

definition of established pharmacologic 

class and to help them identify the most 

appropriate word (term) or phrase that 

describes the established pharmacologic 

class for a drug or biological product for 

inclusion in the Indications and Usage 

section of Highlights of Prescribing 

Information (Highlights) of approved 

labeling. This guidance finalizes the 

draft guidance published in the Federal 

Register on May 16, 2007. 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm 2201, 

Silver Spring, MD 20993–0002, or the 

Office of Communication, Outreach, and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. Submit 

electronic comments to http:// 

www.regulations.gov. Submit written 

comments on the guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Laurie B. Burke, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6462, 

Silver Spring, MD 20993–0002, 

301–796–0136; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration,1401 

Rockville Pike, suite 200N, 

Rockville, MD 20852–1448, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry and review staff 

entitled ‘‘Labeling for Human 

Prescription Drug and Biological 

Products—determining Established 

Pharmacologic Class for Use in the 

Highlights of Prescribing Information.’’ 

This guidance is intended to provide 

applicants and review staff with a 

definition of established pharmacologic 

class and to help them identify the most 

appropriate word (term) or phrase that 

describes the established pharmacologic 

class for a drug or biological product for 

inclusion in the Indications and Usage 

section of Highlights of approved 

labeling, as required under 21 CFR 

201.57(a)(6). 

In January 2006, FDA published a 

final rule that amended the 

requirements for the content and format 

of labeling for human prescription drug 

and biological products.1

The new labeling format is intended 

to make it easier for health care 

professionals to access, read, and use 

the information in prescription drug 

labeling, thereby facilitating 

professionals’ use of labeling to make 

prescribing decisions. 

The rule requires that the following 

statement appear under the Indications 

and Usage section of Highlights if a drug 

is a member of an established 

pharmacologic class:2

‘‘(Drug) is a (name of class) indicated 

for (indication(s)).’’ 

If the drug is not a member of an 

established pharmacologic class, the 

name of class component of this 

statement should be omitted. 

Knowing the established 

pharmacologic class can provide health 

care professionals with important 

information about what to expect from 

a drug and how it relates to other 

therapeutic options. Such information 

can also help reduce the risk of 

duplicative therapy and drug 

interactions. This guidance provides 

recommendations for identifying the 

established pharmacologic class and its 

appropriate term for inclusion in the 

Indications and Usage section of 

Highlights. 

A draft version of this guidance was 

made available for public comment in 

2007 (72 FR 27576, May 16, 2007). All 

of the public comments we received 

have been considered and the guidance 

has been revised as appropriate. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on this topic. 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 statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. 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 information collection 

associated with the final rule entitled 

‘‘Requirements on Content and Format 

of Labeling for Human Prescription 

Drug and Biological Products’’ is 

approved by OMB under Control 

Number 0910–0572. The submission of 

prior-approval labeling supplements, as 

described in section VI of the guidance, 

is approved by OMB under Control 

Numbers 0910–0001 and 0910–0338. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments regarding this document. 

Submit a single copy of electronic 


sroberts on DSKD5P82C1PROD with NOTICES