Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 8887 

Location: The public workshop will 

be held at the Marriott Ann Arbor 

Ypsilanti at Eagle Crest, 1275 S. Huron 

St., Ypsilanti, MI 48197, 800–606–7044. 

Contact: Society of Clinical Research 

Associates (SoCRA), 530 West Butler 

Ave., Suite 109, Chalfont, PA 18914, 

1–800–762–7292 or 215–822–8644, 

FAX: 215–822–8633, email: 

SoCRAmail@aol.com, Web site: http:// 

www.SoCRA.org. (FDA has verified the 

Web site addresses throughout this 

document, but we are not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.); or Nancy 

Bellamy, Food and Drug 

Administration, Detroit District Office, 

300 River Pl., Suite 5900, Detroit, MI 

48207, 313–393–8143, Fax: 313–393– 

8139, email: 

nancy.bellamy@fda.hhs.gov. 

Accommodations: Attendees are 

responsible for their own 

accommodations. Please mention 

SoCRA to receive the hotel room rate of 

$119 plus applicable taxes (available 

until April 17, 2012 or until the SoCRA 

room block is filled). 

COST OF REGISTRATION

SoCRA member ....................... $575 

SoCRA nonmember (includes 

membership) ......................... 650 

Federal Government member .. 450 

Federal Government nonmember ................................. 525 

FDA Employee ......................... * 

* (Free) Fee Waived. 

If you need special accommodations 

due to a disability, please contact 

SoCRA (see Contact) at least 21 days in 

advance. Extended periods of question 

and answer and discussion have been 

included in the program schedule. 

SoCRA designates this educational 

activity for a maximum of 13.3 

Continuing Education Credits for 

SoCRA CE and Nurse CNE. SoCRA 

designates this live activity for a 

maximum of 13.3 AMA PRA Category 1 

Credit(s) TM. Physicians should claim 

only the credit commensurate with the 

extent of their participation. CME for 

Physicians: SoCRA is accredited by the 

Accreditation Council for Continuing 

Medical Education to provide 

continuing medical education for 

physicians. CNE for Nurses: SoCRA is 

an approved provider of continuing 

nursing education by the Pennsylvania 

State Nurses Association (PSNA), an 

accredited approver by the American 

Nurses Credentialing Center’s 

Commission on Accreditation (ANCC). 

ANCC/PSNA Provider Reference 

Number: 205–3–A–09. 

Registration Instructions: To register, 

please submit a registration form with 

your name, affiliation, mailing address, 

telephone, fax number, and email, along 

with a check or money order payable to 

‘‘SoCRA’’. Mail to: SoCRA (see Contact 

for address). To register via the Internet, 

go to http://www.socra.org/html/ 

FDA_Conference.htm. Payment by 

major credit card is accepted (Visa/ 

MasterCard/AMEX only). For more 

information on the meeting registration, 

or for questions on the workshop, 

contact SoCRA (see Contact). 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related to 

informed consent, clinical investigation 

requirements, IRB inspections, 

electronic record requirements, and 

investigator initiated research. Topics 

for discussion include the following: (1) 

What FDA Expects in a Pharmaceutical 

Clinical Trial; (2) Adverse Event 

Reporting—Science, Regulation, Error, 

and Safety; (3) Part 11 Compliance— 

Electronic Signatures; (4) Informed 

Consent Regulations; (5) IRB 

Regulations and FDA Inspections; (6) 

Keeping Informed and Working 

Together; (7) FDA Conduct of Clinical 

Investigator Inspections; (8) Meetings 

With FDA: Why, When, and How; (9) 

Investigator Initiated Research; (10) 

Medical Device Aspects of Clinical 

Research; (11) Working With FDA’s 

Center for Biologics Evaluation and 

Research; (12) The Inspection is Over— 

What Happens Next? Possible FDA 

Compliance Actions; (13) Ethical Issues 

in Subject Enrollment; (14) Medical 

Device Aspects of Clinical Research; 

(15) Are We There Yet? An Overview of 

the FDA GCP Program. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

U.S.C. 393) which includes working 

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The public workshop also is 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Pub. L. 104–121) as outreach 

activities by Government Agencies to 

small businesses. 

Dated: February 9, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3553 Filed 2–14–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director Notice of 

Establishment 

Pursuant to the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

App), the Director, National Institutes of 

Health (NIH), announces the 

establishment of the National Center for 

Advancing Translational Sciences 

Advisory Council (Council) and the 

Cures Acceleration Network Review 

Board (Board), in the National Center for 

Advancing Translation Sciences 

(NCATS). 

The Council will advise, assist, 

consult with, and make 

recommendations to the Secretary of 

Health and Human Services (Secretary), 

the Director, National Institutes of 

Health (NIH) and the Director, National 

Center for Advancing Translational 

Sciences (NCATS, also referred to as 

Center) on matters related to the 

activities carried out by and through the 

Center and the policies respecting these 

activities. 

The Board will advise, and provide 

recommendation to, the Director, 

NCATS, with respect to (1) policies, 

programs, and procedures for carrying 

out the duties of the Director, NCATS, 

under section 480 of the PHS Act; and 

(2) significant barriers to successful 

translation of basic science into clinical 

application (including issues under the 

purview of other agencies and 

departments). 

Duration of each committee is two 

years from the date the Charter is filed. 

Dated: February 7, 2012. 

Francis S. Collins, 

Director, National Institutes of Health. 

[FR Doc. 2012–3572 Filed 2–14–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


sroberts on DSK5SPTVN1PROD with NOTICES
8888 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 

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: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; Outcome 

of Cochlear Implants. 

Date: March 1, 2012. 

Time: 9 a.m. to 10:30 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6120 

Executive Blvd., Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Shiguang Yang, DVM, 

Ph.D., Scientific Review Officer, Division of 

Extramural Activities, NIDCD, NIH, 6120 

Executive Blvd., Bethesda, MD 20892, 301– 

496–8683. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; H & B 

Small Grants. 

Date: March 7, 2012. 

Time: 12 p.m. to 3 p.m.. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6120 

Executive Blvd. Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Sheo Singh, Ph.D. 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Activities, 

Executive Plaza South, Room 400C, 6120 

Executive Blvd., Bethesda, MD 20892, 301– 

496–8683, singhs@nidcd.nih.gov. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders; Special Emphasis Panel; R03–VSL. 

Date: March 8, 2012. 

Time: 11 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6120 

Executive Blvd., Rockville, MD 20852, 

(Telephone Conference Call). 

Contact Person: Christine A. Livingston, 

Ph.D., Scientific Review Officer Division of 

Extramural Activities, National Institutes of 

Health/NIDCD, 6120 Executive Blvd.—MSC 

7180, Bethesda, MD 20892 (301) 496–8683, 

livingsc@mail.nih.gov. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; R03 

Chemosensory. 

Date: March 9, 2012. 

Time: 11 a.m. to 1 p.m.. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6120 

Executive Blvd., Rockville, MD 20852, 

(Telephone Conference Call). 

Contact Person: Kausik Ray, Ph.D., 

Scientific Review Officer, National Institute 

on Deafness and Other Communication 

Disorders, National Institutes of Health, 

Rockville, MD 20850, 301–402–3587, 

rayk@nidcd.nih.gov. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; Clinical 

Trial Review. 

Date: March 13, 2012. 

Time: 11 a.m. to 1 p.m.. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6120 

Executive Blvd., Rockville, MD 20852, 

(Telephone Conference Call). 

Contact Person: Christine A. Livingston, 

Ph.D., Scientific Review Officer, Division of 

Extramural Activities, National Institutes of 

Health/NIDCD, 6120 Executive Blvd.—MSC 

7180, Bethesda, MD 20892, (301) 496–8683, 

livingsc@mail.nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nidcd.nih.gov/about/groups/sep/, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.173, Biological Research 

Related to Deafness and Communicative 

Disorders, National Institutes of Health, HHS) 

Dated: February 9, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–3569 Filed 2–14–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders; 

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 on 

Deafness and Other Communication 

Disorders Special Emphasis Panel, Clinical 

Trial Review. 

Date: February 21, 2012. 

Time: 11 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6120 

Executive Blvd., Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Christine A. Livingston, 

Ph.D., Scientific Review Officer, Division of 

Extramural Activities, National Institutes of 

Health/NIDCD, 6120 Executive Blvd.—MSC 

7180, Bethesda, MD 20892, (301) 496–8683 

livingsc@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nidcd.nih.gov/about/groups/sep/, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.173, Biological Research 

Related to Deafness and Communicative 

Disorders, National Institutes of Health, HHS) 

Dated: February 9, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–3544 Filed 2–14–12; 8:45 am] 

BILLING CODE 4140–01–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: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Systems Neuroscience. 

Date: February 29–March 1, 2012. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 


sroberts on DSK5SPTVN1PROD with NOTICES