47806 Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; 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 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel—NIBIB Training 

Review. 

Date: November 5, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Quincy Hotel, 1823 L Street, 

NW., Washington, DC 20036. 

Contact Person: Manana Sukhareva, PhD, 

Scientific Review Officer, National Institute 

of Biomedical Imaging and Bioengineering, 

6707 Democracy Boulevard, Room 959, 

Bethesda, MD 20892. 301–451–3397. 

sukharem@mail.nih.gov. 

Dated: September 11, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–22432 Filed 9–16–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

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 Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Mentored Clinical Scientist Research 

Awards. 

Date: October 8–9, 2009. 

Time: 8 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza Washington National 

Airport, 1489 Jefferson Davis Hwy, Arlington, 

VA 22202. 

Contact Person: Robert Blaine Moore, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7213, 

Bethesda, MD 20892, 301–594–8394, 

mooreb@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 11, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–22433 Filed 9–16–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0355] 

Submission of Quality Information for 

Biotechnology Products in the Office 

of Biotechnology Products; Notice of 

Extension of Deadlines to Request 

Participation in Pilot Program and to 

Submit Applications; and Notice of 

Increase in the Number of Original 

Applications in Pilot Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

extension of the deadline for submitting 

requests to participate in a pilot 

program involving the submission of 

quality (chemistry, manufacturing, and 

controls (CMC)) information for 

biotechnology products in an Expanded 

Change Protocol consistent with the 

principles of quality-by-design and risk 

management in pharmaceutical 

manufacturing. Because the deadline for 

requests to participate in the pilot is 

being extended, FDA is also extending 

the application submission deadlines. 

FDA is also announcing an increase in 

the number of original applications 

being accepted into the pilot program. 

DATES: Submit written and electronic 

requests to participate in the pilot 

program by September 30, 2010. Submit 

investigational new drug (IND) 

applications and postapproval 

supplements by March 31, 2011. 

ADDRESSES: Submit written requests to 

participate in the pilot program to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic requests to 

participate in the pilot to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Marilyn Welschenbach, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 21, rm. 

1514, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, e-mail: 

Marilyn.Welschenbach@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 2, 2008 

(73 FR 37972) (the July 2, 2008, notice), 

FDA announced that it is seeking 

volunteers from pharmaceutical 

companies to participate in a pilot 

program involving the submission of 

quality (CMC) information for 

biotechnology products in an Expanded 

Change Protocol, consistent with the 

principles of quality-by-design and risk 

management in pharmaceutical 

manufacturing. As explained in the July 

2, 2008, notice, the Office of 

Pharmaceutical Science (OPS), in FDA’s 

Center for Drug Evaluation and Research 

(CDER), is establishing a quality-bydesign, risk-based approach to 

pharmaceutical quality, which is based 

on the FDA final report on 

‘‘Pharmaceutical cGMPs for the 21st 

Century—A Risk-Based Approach’’ 

(http://www.fda.gov/cder/gmp/ 

gmp2004/GMP_finalreport2004.htm). 

The new quality-by-design approach 

will focus on critical quality attributes 

related to chemistry, formulation, and 

process design. Under quality-bydesign, manufacturing will depend on a 

risk-based approach linking attributes 

and processes to product performance, 

safety, and efficacy. 

The principles underlying this new 

approach to a quality-by-design, riskbased assessment can be found in the 

International Conference on 

Harmonisation guidances, ‘‘Q8(R1) 

Pharmaceutical Development,’’ June 

2009 (http://www.fda.gov/downloads/ 

Drugs/GuidanceComplianceRegulatory

Information/Guidances/ 

ucm073507.pdf), and ‘‘Q9 Quality Risk 


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Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices 47807 

Management (ICH),’’ June 2006 (http:// 

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

ucm073511.pdf), and FDA’s guidances 

for industry entitled ‘‘PAT—A 

Framework for Innovative 

Pharmaceutical Development, 

Manufacturing, and Quality Assurance,’’ 

September 2004 (http://www.fda.gov/ 

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

ucm070305.pdf), and ‘‘Quality Systems 

Approach to Pharmaceutical CGMP 

Regulations,’’ September 2006 (http:// 

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

ucm070337.pdf). Quality-by-design and 

risk-based approaches are also described 

in ‘‘Q10 Pharmaceutical Quality 

Systems,’’ April 2009 (http:// 

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

ucm073517.pdf). 

The agency’s Office of New Drug 

Quality Assessment in OPS, CDER, 

initiated a pilot program (70 FR 40719, 

July 14, 2005) to gain experience in 

assessing CMC sections of new drug 

applications (NDAs) that demonstrate 

an applicant’s product knowledge and 

process understanding at the time of 

submission. This pilot was extremely 

useful in helping identify appropriate 

information to be shared regarding 

quality-by-design for small molecules. 

Although many of the principles of 

quality-by-design apply equally to small 

molecules and more complex 

pharmaceuticals, the ability to assess 

relevant attributes is a much greater 

challenge for complex pharmaceuticals. 

Because the pilot program initiated in 

2005 proved constructive, on July 2, 

2008, FDA announced this pilot 

program to provide additional 

information to FDA for use in 

facilitating quality-by-design, risk-based 

approaches for complex molecules. 

Based on experience gained during the 

pilot program and prior knowledge, 

FDA will develop procedures to 

facilitate implementing a quality-bydesign, risk-based approach for complex 

products. In addition, the experience 

gained by FDA under this pilot is 

expected to facilitate the development 

of guidance for industry. The pilot is 

open to original submissions and 

postapproval supplements to biologics 

license applications (BLAs) and NDAs 

reviewed by the Office of Biotechnology 

Products (OBP). 

The July 2, 2008, notice provided 

deadlines related to the submission of 

certain information related to the pilot 

program. To ensure inclusive and 

relevant results from the pilot program, 

this document extends the deadline for 

requests to participate in this pilot 

program for products regulated by OBP 

from September 30, 2009, to September 

30, 2010. Because the deadline for 

requests to participate in the pilot is 

being extended, FDA is also extending 

the application submission deadlines. 

As explained in the July 2, 2008, notice, 

it is preferable for original applications 

to enter the pilot as INDs. FDA is 

extending the deadline for submission 

of INDs from March 31, 2010, to March 

31, 2011. FDA is also extending the 

deadline for submission of postapproval 

supplements from March 31, 2010, to 

March 31, 2011. In addition, the pilot is 

being expanded from five to eight 

original applications for products 

reviewed by OBP (BLA or NDA) in 

Common Technical Document format, 

paper or electronic. See the July 2, 2008, 

notice for instructions on submitting 

requests to participate in the pilot 

program and additional information 

regarding the pilot program. 

Dated: September 11, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22378 Filed 9–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

ADVISORY COUNCIL ON HISTORIC 

PRESERVATION 

Draft Program Comment for the 

National Telecommunications and 

Information Administration and the 

U.S. Department of Agriculture’s Rural 

Utilities Service Regarding the Effects 

of Communication Facilities 

Construction or Modification Subject 

To Review by the Federal 

Communications Commission 

AGENCY: Advisory Council on Historic 

Preservation. 

ACTION: Notice of Intent to Issue 

Program Comments for the National 

Telecommunications and Information 

Administration and the U.S. Department 

of Agriculture’s Rural Utilities Service 

Regarding the Effects of Communication 

Facilities Construction or Modification 

Subject to Review by the Federal 

Communications Commission. 

SUMMARY: The Advisory Council on 

Historic Preservation (ACHP) is 

considering issuing a Program Comment 

for the National Telecommunications 

and Information Administration and the 

U.S. Department of Agriculture’s Rural 

Utilities Service that would relieve them 

of the need to conduct a separate 

Section 106 review regarding the effects 

of communication facilities construction 

or modification that will be subject to 

such review by the Federal 

Communications Commission. The 

ACHP seeks public input on the 

proposed Program Comment. 

DATES: Submit comments on or before 

October 8, 2009. 

ADDRESSES: Address all comments 

concerning this proposed Program 

Comment to Blythe Semmer, Office of 

Federal Agency Programs, Advisory 

Council on Historic Preservation, 1100 

Pennsylvania Avenue, NW., Suite 803, 

Washington, DC 20004. Fax (202) 606– 

8647. You may submit electronic 

comments to: bsemmer@achp.gov. 

FOR FURTHER INFORMATION CONTACT: 

Blythe Semmer, (202) 606– 8552, 

bsemmer@achp.gov; or Laura Dean, 

PhD, RUS Federal Preservation Officer, 

(202) 720–9634, 

laura.dean@wdc.usda.gov. 

SUPPLEMENTARY INFORMATION: Section 

106 of the National Historic 

Preservation Act requires federal 

agencies to consider the effects of their 

undertakings on historic properties and 

to provide the Advisory Council on 

Historic Preservation (ACHP) a 

reasonable opportunity to comment 

with regard to such undertakings. The 

ACHP has issued the regulations that set 

forth the process through which Federal 

agencies comply with these duties. 

Those regulations are codified under 36 

CFR part 800 (Section 106 regulations). 

Under Section 800.14(e) of those 

regulations, agencies can request the 

ACHP to provide a ‘‘Program Comment’’ 

on a particular category of undertakings 

in lieu of conducting individual reviews 

of each individual undertaking under 

such category, as set forth in 36 CFR 

800.4 through 800.7. 

The ACHP is now considering issuing 

a Program Comment to the National 

Telecommunications and Information 

Administration (NTIA) and the U.S. 

Department of Agriculture’s Rural 

Utilities Service (RUS) that would 

relieve them of the need to conduct a 

separate Section 106 review regarding 

the effects of communication facilities 

construction or modification that will be 

subject to such review by the Federal 

Communications Commission (FCC). 

I. Background 

On February 17, 2009, President 

Obama signed the American Recovery 

and Reinvestment Act of 2009 (Recovery 

Act) into law. The Recovery Act 

provides the NTIA and the RUS with 

$7.2 billion to expand access to 

broadband services in the United States. 

In implementing this responsibility, 

NTIA, through its Broadband 


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