Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8971 

On August 5, 2008 (73 FR 45454), 

FDA announced the availability of the 

draft version of this guidance. The 

public comment period closed on 

October 6, 2008. A number of comments 

were received, which the agency 

considered carefully as it finalized the 

guidance and made appropriate 

changes. Most of the changes to the 

guidance were made to clarify 

statements in the draft guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the agency’s 

current thinking on inclusion of 

recommended information to support 

applications for parametric release of 

human and veterinary drug products 

terminally sterilized by moist heat 

processes. 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. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that 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 collection of information 

requested in the guidance is covered 

under FDA regulations at 21 CFR 

314.50, 314.70, and 314.81(b)(2) for 

human drugs; 21 CFR 514.1, 514.8, 

514.8(b)(4) and (c) for animal drugs; and 

21 CFR 601.2 and 601.12 for biologics. 

The collection of information is 

approved under the following OMB 

control numbers: 0910–0001 for human 

drugs, 0910–0600 for animal drugs, and 

0910–0338 for biologics. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, or http:// 

www.regulations.gov. 

Dated: February 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3978 Filed 2–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Eye Institute 

Special Emphasis Panel, NEI K99 Grant 

Applications. 

Date: March 1, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites Hotel—Chevy Chase 

Pavilion Washington, DC 20015. 

Contact Person: Daniel R. Kenshalo, PhD, 

Scientific Review Officer, National Eye 

Institute, National Institutes of Health, 5635 

Fishers Lane, Suite 1300, MSC 9300, 

Bethesda, MD 20892, 301–451–2020, 

kenshalod@nei.nih.gov. 

This Notice is late due to administrative 

procedures. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: February 17 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–3784 Filed 2–25–10; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1514–N] 

Medicare Program; Public Meetings in 

Calendar Year 2010 for All New Public 

Requests for Revisions to the 

Healthcare Common Procedure Coding 

System (HCPCS) Coding and Payment 

Determinations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

dates, time, and location of the 

Healthcare Common Procedure Coding 

System (HCPCS) public meetings to be 

held in calendar year 2010 to discuss 

our preliminary coding and payment 

determinations for all new public 

requests for revisions to the HCPCS. 

These meetings provide a forum for 

interested parties to make oral 

presentations or to submit written 

comments in response to preliminary 

coding and payment determinations. 

Discussion will be directed toward 

responses to our specific preliminary 

recommendations and will include all 

items on the public meeting agenda. 

DATES: Meeting Dates: The following are 

the 2010 HCPCS public meeting dates: 

1. Tuesday, May 4, 2010, 9 a.m. to 5 

p.m., eastern daylight time (e.d.t.) 

(Drugs/Biologicals/ 

Radiopharmaceuticals/Radiologic 

Imaging Agents). 

2. Wednesday, May 5, 2010, 9 a.m. to 

5 p.m., e.d.t. (Drugs/Biologicals/ 

Radiopharmaceuticals/Radiologic 

Imaging Agents). 

3. Tuesday, May 25, 2010, 9 a.m. to 

5 p.m., e.d.t. (Supplies and Other). 

4. Wednesday, May 26, 2010, 9 a.m. 

to 5 p.m., e.d.t. (Supplies and Other). 

5. Thursday, May 27, 2010, 9 a.m. to 

5 p.m, e.d.t. (Orthotics and Prosthetics). 

6. Tuesday, June 8, 2010, 9 a.m. to 5 

p.m., e.d.t. (Durable Medical Equipment 

(DME) and Accessories). 

Deadlines for Primary Speaker 

Registration and Presentation Materials: 

The deadline for registering to be a 

primary speaker, and submitting 

materials and writings that will be used 

in support of an oral presentation are as 

follows: 

• April 20, 2010 for the May 4 and 5, 

2010 public meetings. 

• May 11, 2010 for the May 25, 26 

and 27, 2010 public meetings. 

• May 25, 2010 for the June 8, 2010 

public meeting. 

Deadline for Attendees that are 

Foreign Nationals (reside outside the 


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U.S.) Registration: Attendees that are 

Foreign Nationals (reside outside the 

U.S.) need to identify themselves as 

such, and provide the necessary 

information for security clearance as 

described in section IV. of this notice to 

the public meeting coordinator at least 

10 business days in advance of the 

public meeting date in which the 

individual plans to attend. 

Deadlines for all Other Attendees 

Registration: All individuals must 

register for each date that they plan on 

attending. The registration deadlines are 

different for each meeting. Registration 

deadlines are as follows: 

• April 27, 2010 for the May 4 and 5, 

2010 public meeting dates. 

• May 18, 2010 for the May 25, 26 

and 27, 2010 public meeting dates. 

• June 1, 2010 for the June 8, 2010 

public meeting date. 

Deadlines for Requesting Special 

Accommodations: 

• April 20, 2010 for the May 4 and 5, 

2010 public meeting dates. 

• May 11, 2010 for the May 25, 26 

and 27, 2010 public meeting dates. 

• May 25, 2010 for the June 8, 2010 

public meeting. 

Deadline for Submission of Written 

Comments: Written comments must be 

received by the date of meeting at which 

a request is scheduled for discussion. 

ADDRESSES: Meeting Location: The 

public meetings will be held in the main 

auditorium of the central building of the 

Centers for Medicare and Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244–1850. 

Submission of Written Comments: 

Written comments can be e-mailed to 

HCPCS@cms.hhs.gov or sent via regular 

mail to Jennifer Carver or Geneva 

Harkness, HCPCS Public Meeting 

Coordinator, Centers for Medicare & 

Medicaid Services, 7500 Security 

Boulevard, Mail Stop C5–08–27, 

Baltimore, MD 21244. 

Registration and Special 

Accommodations: Individuals wishing 

to participate or who need special 

accommodations or both must register 

by completing the on-line registration 

located at http://www.cms.hhs.gov/ 

medhcpcsgeninfo or by contacting one 

of the following persons: Jennifer Carver 

at (410) 786–6610 or 

Jennifer.Carver@cms.hhs.gov; or Geneva 

Harkness at (410) 786–6951 or 

Geneva.Harkness@cms.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Carver at (410) 786–6610 or 

Jennifer.Carver@cms.hhs.gov; or Geneva 

Harkness at (410) 786–6951 or 

Geneva.Harkness@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 21, 2000, the Congress 

passed the Medicare, Medicaid, and 

SCHIP Benefits Improvement and 

Protection Act of 2000 (BIPA) (Pub. L. 

106–554). Section 531(b) of BIPA 

mandated that we establish procedures 

that permit public consultation for 

coding and payment determinations for 

new durable medical equipment (DME) 

under Medicare Part B of title XVIII of 

the Social Security Act (the Act). The 

procedures and public meetings 

announced in this notice for new DME 

are in response to the mandate of 

section 531(b) of BIPA. 

In the November 23, 2001 Federal 

Register (66 FR 58743), we published a 

notice providing information regarding 

the establishment of the public meeting 

process for DME. It is our intent to 

distribute any materials submitted to 

CMS to the HCPCS workgroup members 

for their consideration. CMS and the 

HCPCS workgroup members require 

sufficient preparation time to review all 

relevant materials. Therefore, we are 

implementing a 10-page submission 

limit and firm deadlines for receipt of 

any presentation materials the meeting 

participant wishes CMS to consider. For 

this reason, our HCPCS Public Meeting 

Coordinators will only accept and 

review presentation materials received 

by the deadline for each public meeting, 

as specified in the DATES section of this 

notice. 

The public meeting process provides 

an opportunity for the public to become 

aware of coding changes under 

consideration, as well as an opportunity 

for CMS to gather public input. 

II. Meeting Registration 

A. Required Information for Registration 

The following information must be 

provided when registering: 

• Name. 

• Company name and address. 

• Direct-dial telephone and fax 

numbers. 

• E-mail address. 

• Special needs information. 

A CMS staff member will confirm your 

registration by e-mail. 

B. Registration Process 

1. Primary Speakers 

Individuals must also indicate 

whether they are the ‘‘primary speaker’’ 

for an agenda item. Primary speakers 

must be designated by the entity that 

submitted the HCPCS coding request. 

When registering, primary speakers 

must provide a brief written statement 

regarding the nature of the information 

they intend to provide, and advise the 

HCPCS Public Meeting Coordinator 

regarding needs for audio/visual 

support. To avoid disruption of the 

meeting and ensure compatibility with 

our systems, tapes and disk files are 

tested and arranged in speaker sequence 

well in advance of the meeting. We will 

accept tapes and disk files that are 

received by the deadline for 

submissions for each public meeting as 

specified in the DATES section of this 

notice. The sum of all materials 

including the presentation may not 

exceed 10 pages (each side of a page 

counts as 1 page). An exception will be 

made to the 10-page limit for relevant 

studies published between the 

application deadline and the public 

meeting date, in which case, we would 

like a copy of the complete publication 

as soon as possible. 

These materials may be delivered by 

regular mail postmark date no later than 

the deadline date or by e-mail to one of 

the HCPCS Public Meeting Coordinators 

as specified in the ADDRESSES section of 

this notice. Individuals will need to 

provide 35 copies if materials are 

delivered by mail. 

2. 5-Minute Speakers 

To afford the same opportunity to all 

attendees, 5-minute speakers are not 

required to register as primary speakers. 

However, 5-minute speakers must still 

register as attendees by the deadline set 

forth under ‘‘Deadlines for all Other 

Attendees Registration’’ in the DATES

section of this notice. Attendees can 

sign up only on the day of the meeting 

to do a 5-minute presentation. 

Individuals must provide their name, 

company name and address, contact 

information as specified on the sign-up 

sheet, and identify the specific agenda 

item that they will address. 

C. Additional Meeting/Registration 

Information 

Public Meetings are scheduled far in 

advance of the influx of HCPCS 

applications each cycle. At the time 

they are scheduled we can only 

anticipate the number of applications 

that we receive in each category. As a 

result, we may not need the second day 

of Drugs/Biologicals/ 

Radiopharmaceuticals/Radiologic 

Imaging Agents Public Meeting 

Wednesday, May 5, 2010. We have 

scheduled this date tentatively. The 

Public Meeting Agendas published on 

CMS’ HCPCS Web site at http:// 

www.cms.hhs.gov/medhcpcsgeninfo 

will serve as final notification regarding 

whether a meeting will be held on May 

5, 2010. 

The product category reported by the 

applicant may not be the same as that 


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Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8973 

assigned by CMS. Prior to registering to 

attend a public meeting, all participants 

are advised to review the public meeting 

agendas at http://www.cms.hhs.gov/ 

medhcpcsgeninfo which identify our 

category determinations, and the dates 

each item will be discussed. Draft 

agendas, including a summary of each 

request and CMS’ preliminary decision 

will be posted on our HCPCS Web site 

at http://www.cms.hhs.gov/ 

medhcpcsgeninfo at least 4 weeks before 

each meeting. 

Additional details regarding the 

public meeting process for all new 

public requests for revisions to the 

HCPCS, along with information on how 

to register and guidelines for an 

effective presentation, will be posted at 

least 4 weeks before the first meeting 

date on the HCPCS Web site at http:// 

www.cms.hhs.gov/medhcpcsgeninfo. 

Individuals who intend to provide a 

presentation at a public meeting need to 

familiarize themselves with the HCPCS 

Web site and the valuable information it 

provides to prospective registrants. The 

HCPCS Web site contains a document 

titled ‘‘Healthcare Common Procedure 

Coding System (HCPCS) Level II Coding 

Procedures,’’ which is a description of 

the HCPCS coding process, including a 

detailed explanation of the procedures 

used to make coding determinations for 

all the products, supplies, and services 

that are coded in the HCPCS. 

The HCPCS Web site also contains a 

document titled ‘‘HCPCS Decision Tree 

& Definitions’’ which illustrates, in flow 

diagram format, HCPCS coding 

standards as described in our Coding 

Procedures document. A summary of 

each public meeting will be posted on 

the HCPCS Web site by the end of 

August 2010. 

III. Presentations and Comment Format 

We can only estimate the amount of 

meeting time that will be needed since 

it is difficult to anticipate the total 

number of speakers that will register for 

each meeting. Meeting participants 

should arrive early to allow time to clear 

security and sign-in. Each meeting is 

expected to begin promptly as 

scheduled. Meetings may end earlier 

than the stated ending time. 

A. Oral Presentation Procedures 

Individuals who are planning to 

provide an oral presentation must 

register as provided under the section 

titled ‘‘Meeting Registration.’’ Materials 

and writings that will be used in 

support of an oral presentation should 

be submitted to one of the HCPCS 

Public Meeting Coordinators. 

These materials may be delivered by 

regular mail (postmark date no later 

than the deadline date) or by e-mail to 

one of the HCPCS Public Meeting 

Coordinators specified in the ADDRESSES

section. Individuals will need to include 

35 copies if materials are delivered by 

mail. 

B. Primary Speaker Presentations 

The individual or entity requesting 

revisions to the HCPCS coding system 

for a particular agenda item may 

designate one ‘‘primary speaker’’ to 

make a presentation for a maximum of 

15 minutes. Fifteen minutes is the total 

time interval for the presentation, and 

the presentation must incorporate the 

demonstration, set-up, and distribution 

of material. In establishing the public 

meeting agenda, we may group 

multiple, related requests under the 

same agenda item. In that case, we will 

decide whether additional time will be 

allotted, and may opt to increase the 

amount of time allotted to the speaker 

by increments of less than 15 minutes. 

We will post ‘‘Guidelines for 

Participation in Public Meetings for All 

New Public Requests for Revisions to 

the Healthcare Common Procedure 

Coding System (HCPCS)’’ on the official 

HCPCS Web site at least 4 weeks before 

the first public meeting in 2010 for all 

new public requests for revisions to the 

HCPCS. Individuals designated to be the 

primary speaker must register to attend 

the meeting using the registration 

procedures described under the 

‘‘Meeting Registration’’ section of this 

notice and contact one of the HCPCS 

Public Meeting Coordinators, specified 

in the ADDRESSES section. Primary 

speakers must also separately register as 

primary speakers by the date specified 

in the DATES section of this notice. 

C. ‘‘5-Minute’’ Speaker Presentations 

Meeting attendees can sign up at the 

meeting, on a first-come, first-served 

basis, to make 5-minute presentations 

on individual agenda items. Based on 

the number of items on the agenda and 

the progress of the meeting, a 

determination will be made at the 

meeting by the meeting coordinator and 

the meeting moderator regarding how 

many 5-minute speakers can be 

accommodated. 

D. Speaker Declaration 

On the day of the meeting, before the 

end of the meeting, all primary speakers 

and 5-minute speakers must provide a 

brief written summary of their 

comments and conclusions to the 

HCPCS Public Meeting Coordinator. 

Each primary speaker and 5-minute 

speaker must declare in their 

presentation at the meeting, as well as 

in their written summary, whether they 

have any financial involvement with the 

manufacturers or competitors of any 

items being discussed; this includes any 

payment, salary, remuneration, or 

benefit provided to that speaker by the 

manufacturer or the manufacturer’s 

representatives. 

E. Written Comments From Meeting 

Attendees 

Written comments will be accepted 

from the general public and meeting 

registrants anytime up to the date of the 

public meeting at which a request is 

discussed. Comments must be sent to 

the address listed in the ADDRESSES

section of this notice. 

Meeting attendees may also submit 

their written comments at the meeting. 

Due to the close timing of the public 

meetings, subsequent workgroup 

reconsiderations, and final decisions, 

we are able to consider only those 

comments received in writing by the 

close of the public meeting at which the 

request is discussed. 

IV. Security, Building, and Parking 

Guidelines 

The meetings are held in a Federal 

government building; therefore, Federal 

security measures are applicable. In 

planning your arrival time, we 

recommend allowing additional time to 

clear security. In order to gain access to 

the building and grounds, participants 

must bring government-issued photo 

identification and a copy of your written 

meeting registration confirmation. 

Persons without proper identification 

will be denied access. 

CMS has had a long standing policy 

of established Visitor and Foreign 

National Visitor controls that effectively 

control access to sensitive facilities and 

restricted/controlled areas containing 

CMS information, information systems, 

and media libraries. Visitors shall be 

authenticated prior to being granted 

access to facilities or areas other than 

areas designated as publicly accessible. 

Government contractors and others with 

permanent authorization credentials are 

not considered visitors. 

However, HHS policy requires us to 

ensure that a government employee, US 

citizen host/hosting official is assigned 

to every foreign national visitor visiting 

an HHS facility. As such, the host/ 

hosting official is required to inform the 

Security and Emergency Management 

Group (SEMG) Division of Physical 

Security, at least 10 business days in 

advance of any visit by a foreign 

national visitor. 

No visitor is allowed to attach USB 

cables, thumb drives or any other 

equipment to any CMS information 

technology (IT) system or hardware for 


sroberts on DSKD5P82C1PROD with NOTICES
8974 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 

any purpose at anytime. Additionally, 

CMS staff is prohibited from taking such 

actions on behalf of a visitor or utilizing 

any removable media provided by a 

visitor. 

Attendees that are Foreign Nationals 

(reside outside the U.S.) need to identify 

themselves as such, and provide the 

following information for security 

clearance to the public meeting 

coordinator by the date specified in the 

DATES section of this notice: 

• Visitor’s full name (as it appears on 

passport); 

• Gender; 

• Country of origin and citizenship; 

• Biographical data and related 

information; 

• Date of birth; 

• Place of birth; 

• Passport number; 

• Passport issue date; 

• Passport expiration date; and 

• Dates of visits. 

Individuals who are not registered in 

advance will not be permitted to enter 

the building and will be unable to 

attend the meeting. The public may not 

enter the building earlier than 45 

minutes before the convening of the 

meeting each day. 

Security measures will also include 

inspection of vehicles, inside and 

outside, at the entrance to the grounds 

and buildings. In addition, all persons 

entering the building must pass through 

a metal detector. All items brought to 

CMS are subject to inspection. We 

cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for 

demonstration or to support a 

presentation. Special arrangements and 

approvals are required in order to bring 

pieces of equipment or medical devices 

at least 2 weeks prior to each public 

meeting. These arrangements need to be 

made with the public meeting 

coordinator. It is possible that certain 

requests made in advance of the public 

meeting could be denied because of 

unique safety, security or handling 

issues related to the equipment. A 

minimum of 2 weeks is required for 

approvals and security procedures. Any 

request not submitted at least 2 weeks 

in advance of the public meeting will be 

denied. 

Parking permits and instructions are 

issued upon arrival by the guards at the 

main entrance. 

All visitors must be escorted by 

agency staff in order to enter areas other 

than the public areas on the lower and 

first-floor levels in the Central Building. 

Authority: Section 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 42 

U.S.C. 1395hh). 

Dated: February 18, 2010. 

Charlene Frizzera, 

Acting Adminstrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2010–3722 Filed 2–25–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Maternal and Child 

Health in Poor Countries: Evidence from 

Randomized Evaluations. 

Date: March 18, 2010. 

Time: 11 a.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Room 5B01, Rockville, 

MD 20852.(Telephone Conference Call) 

Contact Person: Carla T. Walls, PhD, 

Scientific Review Officer, Division of 

Scientific Review, Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development, NIH, 6100 Executive 

Blvd., Room 5B01, Bethesda, MD 20892, 

(301) 435–6898, wallsc@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the closing 

of the Federal Government the week of 

February 7, 2010. The Federal Government 

was closed due to inclement weather 

conditions. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: February 19, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–4081 Filed 2–25–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

Scientific Management Review Board. 

The NIH Reform Act of 2006 (Pub. L. 

109–482) provides organizational 

authorities to HHS and NIH officials to: 

(1) Establish or abolish national research 

institutes; (2) reorganize the offices 

within the Office of the Director, NIH 

including adding, removing, or 

transferring the functions of such offices 

or establishing or terminating such 

offices; and (3) reorganize, divisions, 

centers, or other administrative units 

within an NIH national research 

institute or national center including 

adding, removing, or transferring the 

functions of such units, or establishing 

or terminating such units. The purpose 

of the Scientific Management Review 

Board (also referred to as SMRB or 

Board) is to advise appropriate HHS and 

NIH officials on the use of these 

organizational authorities and identify 

the reasons underlying the 

recommendations. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Scientific 

Management Review Board. 

Date: March 10, 2010. 

Time: 8 a.m. to 4:30 p.m. 

Agenda: Presentation and discussion will 

include updates from SMRB Working 

Groups; Deliberating Organization Change 

and Effectiveness; NIH Intramural Research 

Program; and Substance Use, Abuse, and 

Addiction. The Board will also discuss 

perspectives on organizational change. Time 

will be allotted on the agenda for public 

comment. Sign up for public comment will 

begin at approximately 7 a.m. and will be 

restricted to one sign in per person. In the 

event that time does not allow for all those 

interested to present oral comments, anyone 

may file written comments using the contact 

person address below. 


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