Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices 69093 

Boulevard, Bethesda, MD 20892. (Telephone 

Conference Call) 

Contact Person: Robert Wellner, PhD, 

Scientific Review Officer, Review Branch, 

Dea, Niddk, National Institutes of Health, 

Room 706, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452. 301–594–4721. 

Rw175w@Nih.Gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: November 3, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–28295 Filed 11–9–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 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: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, Pediatric Ancillary 

Study to ASSESS–AKI. 

Date: December 7, 2010. 

Time: 2:15 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892. (Telephone 

Conference Call) 

Contact Person: Lakshmanan Sankaran, 

PhD Scientific Review Officer, Review 

Branch, Dea, NIDDK, National Institutes Of 

Health, Room 755, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

594–7799, Ls38z@Nih.Gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, Bone 

Morphogenesis Program Project Review. 

Date: December 8, 2010. 

Time: 2 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health. Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892. (Telephone 

Conference Call) 

Contact Person: Lakshmanan Sankaran, 

PhD Scientific Review Officer, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 755, 6707 Democracy 

Boulevard, Bethesda, Md 20892–5452. (301) 

594–7799. Ls38z@Nih.Gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: November 3, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–28293 Filed 11–9–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0128] 

Prescription Drug User Fee Act; 

Reopening of the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

October 31, 2011, the comment period 

for the notice of public meeting that 

published in the Federal Register of 

March 16, 2010 (75 FR 12555). In the 

notice, FDA announced a public 

meeting to solicit input on the 

reauthorization of the Prescription Drug 

User Fee Act (PDUFA) program. The 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) requires public review 

of the recommendations for the human 

drug review program after negotiations 

with the regulated industry conclude. 

FDA expects that this additional public 

process will be complete by October 

2011. FDA is reopening the comment 

period for the expected duration of the 

public part of the reauthorization 

process to ensure that all interested 

stakeholders have the opportunity to 

share their views on the matter. 

DATES: Submit either electronic or 

written comments by October 31, 2011. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Frey, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1174, Silver Spring, 

MD 20993–0002, 301–796–3844, FAX: 

301–847–8443, e-mail: 

PDUFAReauthorization@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 16, 

2010 (75 FR 12555), FDA published a 

notice of a public meeting on PDUFA 

reauthorization and invited comments. 

In the notice, the Agency stated that the 

authority for PDUFA expires in 

September 2012. Without new 

legislation, FDA will no longer be able 

to collect user fees to fund the human 

drug review process. Section 736B(d)(2) 

(21 U.S.C. 379h-2(d)(2)) of the FD&C Act 

requires that before FDA begins 

negotiations with the regulated industry 

on PDUFA reauthorization, we do the 

following: (1) Publish a notice in the 

Federal Register requesting public input 

on the reauthorization, (2) hold a public 

meeting at which the public may 

present its views on the reauthorization, 

(3) provide a period of 30 days after the 

public meeting to obtain written 

comments from the public suggesting 

changes, and (4) publish the comments 

on the FDA Web site. 

The public meeting was held on April 

12, 2010, and interested persons were 

given until May 12, 2010, to submit 

comments. The written comments 

submitted during that period are now 

published on the FDA Web site at 

http://www.fda.gov/ForIndustry/

UserFees/PrescriptionDrugUserFee/

ucm215804.htm. To ensure that all 

interested persons have sufficient 

opportunity to share their views on 

PDUFA throughout the reauthorization 

process, FDA is reopening the comment 

period until October 31, 2011. The 

FD&C Act requires public review of the 

recommendations for the human drug 

review program after negotiations with 

the regulated industry conclude. FDA 

expects that the public component of 

the reauthorization process will be 

complete by October 2011. Therefore, 

the Agency is reopening the comment 

period for this anticipated duration to 

ensure that all interested stakeholders 

have the opportunity to share their 

views on the matter. 


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