60762 Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

Web site location where it will post a 

list of guidance documents the Center 

for Devices and Radiological Health 

(CDRH) is considering for development. 

In addition, FDA has established a 

docket where stakeholders may provide 

comments and/or draft language for 

those topics as well as suggestions for 

new or different guidances. 

DATES: Submit either written or 

electronic comments at any time. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Pirt, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. WO66, rm. 4438, Silver 

Spring, MD 20993, 301–796–5739. 

SUPPLEMENTARY INFORMATION: 

I. Background 

During negotiations over the 

reauthorization of the Medical Device 

User Fee and Modernization Act 

(MDUFMA), FDA agreed, in return for 

additional funding from industry, to 

meet a variety of quantitative and 

qualitative goals intended to help get 

safe and effective medical devices to 

market more quickly. These 

commitments include annually posting 

a list of guidance documents that CDRH 

is considering for development and 

providing stakeholders an opportunity 

to provide comments and/or draft 

language for those topics, or suggestions 

for new or different guidances. This 

notice announces the Web site location 

of the list of guidances on which CDRH 

is intending to work over the next Fiscal 

Year (FY). We note that the agency is 

not required to issue every guidance on 

the list, nor is it precluded from issuing 

guidance documents that are not on the 

list. The list includes topics that 

currently have no guidance associated 

with them, topics where updated 

guidance may be helpful, and topics for 

which CDRH has already issued level 1 

drafts that may be finalized following 

review of public comments. We will 

consider stakeholder comments as we 

prioritize our guidance efforts. 

FDA and CDRH priorities are subject 

to change at any time. Topics on this 

and past guidance priority lists may be 

removed or modified based on current 

priorities. We also note that CDRH’s 

experience over the years has shown 

that there are many reasons CDRH staff 

does not complete the entire annual 

agenda of guidances it undertakes. Staff 

are frequently diverted from guidance 

development to other activities, 

including review of premarket 

submissions or postmarket problems. In 

addition, the Center is required each 

year to issue a number of guidances that 

it cannot anticipate at the time the 

annual list is generated. These may 

involve newly identified public health 

issues as well as special control 

guidance documents for de novo 

classifications of devices. It will be 

helpful, therefore, to receive comments 

that indicate the relative priority of 

different guidance topics to interested 

stakeholders. 

Through feedback from stakeholders, 

including draft language for guidance 

documents, CDRH expects to be able to 

better prioritize and more efficiently 

draft guidances that will be useful to 

industry and other stakeholders. This 

will be the fourth annual list CDRH has 

posted. FDA intends to update the list 

each year. 

FDA invites interested persons to 

submit comments on any or all of the 

guidance documents on the list. FDA 

has established a docket where 

comments about the FY 2011 list, draft 

language for guidance documents on 

those topics, and suggestions for new or 

different guidances may be submitted 

(see ADDRESSES). FDA believes this 

docket is an important tool for receiving 

information from interested parties and 

for sharing this information with the 

public. Similar information about 

planned guidance development is 

included in the annual agency-wide 

notice issued by FDA under its good 

guidance practices (21 CFR 10.115(f)(5)). 

This CDRH list, however, will be 

focused exclusively on device-related 

guidances and will be made available on 

FDA’s Web site prior to the beginning of 

each FY from 2008 to 2012. 

To access the list of the guidance 

documents CDRH is considering for 

development in FY 2011, visit the FDA 

Web site http://www.fda.gov/Medical

Devices/DeviceRegulationandGuidance/ 

Overview/MedicalDeviceUserFee

andModernizationActMDUFMA/ 

ucm109196.htm. 

II. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

Dated: September 28, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–24669 Filed 9–30–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors (BSC), 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry (NCEH/ATSDR) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), CDC and NCEH/ 

ATSDR announces the following 

committee meeting: 

TIMES AND DATES: 

8:30 a.m.–4:15 p.m., October 21, 2010. 

8:30 a.m.–12 p.m., October 22, 2010. 

PLACE: CDC, 4770 Buford Highway, 

Atlanta, Georgia 30341. 

STATUS: Open to the public, limited only 

by the space available. The meeting 

room accommodates approximately 75 

people. 

PURPOSE: The Secretary, Department of 

Health and Human Services (HHS) and 

by delegation, the Director, CDC and 

Administrator, NCEH/ATSDR, are 

authorized under Section 301 (42 U.S.C. 

241) and Section 311 (42 U.S.C. 243) of 

the Public Health Service Act, as 

amended, to: (1) Conduct, encourage, 

cooperate with, and assist other 

appropriate public authorities, scientific 

institutions, and scientists in the 

conduct of research, investigations, 

experiments, demonstrations, and 

studies relating to the causes, diagnosis, 

treatment, control, and prevention of 

physical and mental diseases and other 

impairments; (2) assist States and their 

political subdivisions in the prevention 

of infectious diseases and other 

preventable conditions and in the 

promotion of health and well being; and 

(3) train State and local personnel in 

health work. The BSC, NCEH/ATSDR 

provides advice and guidance to the 

Secretary, HHS; the Director, CDC and 

Administrator, ATSDR; and the 

Director, NCEH/ATSDR, regarding 

program goals, objectives, strategies, and 

priorities in fulfillment of the agency’s 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 60763 

mission to protect and promote people’s 

health. The board provides advice and 

guidance that will assist NCEH/ATSDR 

in ensuring scientific quality, 

timeliness, utility, and dissemination of 

results. The board also provides 

guidance to help NCEH/ATSDR work 

more efficiently and effectively with its 

various constituents and to fulfill its 

mission in protecting America’s health. 

MATTERS TO BE DISCUSSED: The agenda 

items for the BSC Meeting on October 

21–22, 2010 will include presentations 

from the Division of Environmental 

Hazards and Health Effects to the BSC 

on Air Pollution and Respiratory Health, 

Environmental Health Tracking, and 

Climate Control; a discussion of ATSDR 

Funded State Reports; an update on 

Amyotrophic Lateral Sclerosis (ALS) 

Registry; Director Updates on ATSDR; 

Director Updates on NCEH and Program 

Response to BSC Program Peer Review 

of the Division of Laboratory Sciences. 

Agenda items are subject to change as 

priorities dictate. 

SUPPLEMENTARY INFORMATION: The 

public comment period is scheduled 

from 3:45 p.m. until 4 p.m. October 21, 

2010. 

CONTACT PERSON FOR MORE INFORMATION: 

Sandra Malcom, Committee 

Management Specialist, NCEH/ATSDR, 

CDC, 4770 Buford Highway, Mail Stop 

F–61, Chamblee, Georgia 30345; 

telephone 770/488–0575, fax 770/488– 

3377; E-mail: smalcom@cdc.gov. The 

deadline for notification of attendance is 

October 15, 2010. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

NCEH/ATSDR. 

Dated: September 27, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–24671 Filed 9–30–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

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 meetings. 

The meetings 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: Healthcare Delivery 

and Methodologies Integrated Review Group, 

Biostatistical Methods and Research Design 

Study Section. 

Date: October 21, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: InterContinental Mark Hopkins 

Hotel, 999 California Street, San Francisco, 

CA 94108. 

Contact Person: Tomas Drgon, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3152, 

MSC 7770, Bethesda, MD 20892, 301–435– 

1017, tdrgon@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Enabling Bioanalytical and Imaging 

Technologies. 

Date: October 29, 2010. 

Time: 10 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call) 

Contact Person: Allen Richon, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6181, 

MSC 7892, Bethesda, MD 20892, 301–435– 

2902, allen.richon@nih.hhs.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Topics in Microbial Diseases. 

Date: November 1–2, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting) 

Contact Person: Liangbiao Zheng, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3214, 

MSC 7808, Bethesda, MD 20892, 301–402– 

5671, zhengli@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Diabetes, 

Obesity and Endocrine Disorders. 

Date: November 2–3, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting) 

Contact Person: Krish Krishnan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6164, 

MSC 7892, Bethesda, MD 20892, (301) 435– 

1041, krishnak@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Fellowships: Physiology and Pathobiology of 

Cardiovascular and Respiratory Systems. 

Date: November 18–19, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Fairmont San Francisco, 950 

Mason Street, San Francisco, CA 94108. 

Contact Person: Abdelouahab Aitouche, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4222, 

MSC 7812, Bethesda, MD 20892, 301–435– 

2365, aitouchea@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 27, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–24680 Filed 9–30–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Privacy Act of 1974; Report of an 

Altered System of Records 

AGENCY: Department of Health and 

Human Services (HHS), Health 

Resources and Services Administration 

(HRSA). 

ACTION: Notice of an Altered System of 

Records (SOR). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

the Health Resources and Services 

Administration (HRSA) is publishing a 

notice to alter the system of records for 

the National Practitioner Data Bank for 

Adverse Information on Physicians and 

other Health Care Practitioners, HHS/ 

HRSA/BHPR. The SORN 09–15–0054 

was last published March 17, 1997. In 

accordance with the Health Care Quality 

Improvement Act of 1986, as amended, 

title IV of Public Law 99–660 (42 U.S.C. 

11101 et seq.) authorizes the Secretary 

to establish a National Practitioner Data 

Bank (NPDB) to collect and release 

certain information relating to the 

professional competence and conduct of 

physicians, dentists, and other health 

care practitioners. This information is 

releasable only to specific entities 

described in the SORN. It requires the 


emcdonald on DSK2BSOYB1PROD with NOTICES