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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47808 Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices 

Technology Opportunities Program 

(BTOP), will award grants to expand 

public computer capacity, encourage 

sustainable adoption of broadband 

service and deploy broadband 

infrastructure to unserved and 

underserved areas. RUS, through its 

Broadband Initiatives Program (BIP), 

will use loan and grant combinations to 

support broadband deployment in rural 

communities. 

Technological solutions available to 

speed the deployment of affordable 

broadband under those programs are 

diverse and include the construction 

and modification of communications 

towers and antennas. Some of those 

communication towers and antennas 

will be regulated by the FCC. For such 

proposals that are regulated by the FCC 

and assisted by RUS and/or NTIA, each 

agency would be individually 

responsible for compliance with Section 

106. 

The FCC, ACHP, and the National 

Conference of State Historic 

Preservation Officers (NCSHPO) have 

executed the Nationwide Programmatic 

Agreement for Review of Effects on 

Historic Properties For Certain 

Undertakings Approved by the FCC 

(FCC Nationwide PA) and the 

Nationwide Programmatic Agreement 

for the Collocation of Wireless Antennas 

(FCC Collocation PA) to govern how 

FCC meets its Section 106 

responsibilities for certain undertakings, 

including communication towers and 

antennas. In implementing the terms of 

those programmatic agreements, FCC 

has established a procedure that is 

supported by innovative approaches 

that expedite review and facilitate the 

involvement of stakeholders, most 

notably Indian tribes, to ensure that 

effects to historic properties are taken 

into account. 

Currently, it is not possible for RUS 

and NTIA to benefit from the 

implementation of those programmatic 

agreement solutions in meeting their 

individual Section 106 responsibilities, 

because the FCC Nationwide PA 

stipulates that it does not govern the 

Section 106 responsibilities of any 

federal agency other than the FCC. This 

means that FCC, RUS and NTIA must 

each conduct separate Section 106 

reviews for the same proposed 

undertaking. Such an approach does not 

seem to be efficient, particularly within 

the context of the compressed schedules 

established by the Recovery Act. 

Accordingly, pursuant to 36 CFR 

800.14(e), NTIA and RUS have 

requested the ACHP to issue a program 

comment that removes their 

requirement to comply with Section 106 

with regard to the effects of 

communications facilities construction 

or modification that has undergone, will 

undergo, or is exempt from, Section 106 

review by the FCC under the cited FCC 

programmatic agreements. 

Under the Recovery Act, all NTIA and 

RUS grants and loans must be awarded 

by September 30, 2010. Construction of 

proposals receiving awards must be 

complete within three years of the 

award. Recovery Act responsibilities of 

NTIA and RUS, therefore, will extend to 

2013. In order to accommodate for 

currently unknown contingencies, RUS 

and NTIA have requested that the 

effective termination of the proposed 

program comment be extended to 

September 30, 2015. 

RUS and NTIA have informed the 

ACHP that, prior to their formal request, 

they sought to share their intent to 

develop this program comment with the 

following historic preservation, tribal, 

and telecommunications industry 

organizations: National Trust for 

Historic Preservation, NCSHPO, 

American Cultural Resources 

Association, National Association of 

Tribal Historic Preservation Officers 

(NATHPO), United South and Eastern 

Tribes (USET), National Congress of 

American Indians, Affiliated Tribes of 

Northwest Indians, Office of Hawaiian 

Affairs (OHA), CTIA The Wireless 

Association, PCIA—The Wireless 

Infrastructure Association, and the 

Association of Public Safety 

Communications Officials. RUS and 

NTIA discussed this proposal with all of 

the listed parties except OHA, and 

reported that, in general, those 

organizations contacted were 

supportive, noting that this approach 

represented a common sense solution. 

In addition to those parties, NTIA and 

RUS have worked closely with the FCC 

throughout the development of the 

proposed program comment. 

RUS and NTIA also reported that 

several parties expressed concern that 

the proposed program comment would 

alter or modify the FCC Nationwide PA. 

That is not the intent of the proposed 

program comment and a statement to 

that effect has been included in the 

proposal itself. 

RUS and NTIA anticipate that BTOP/ 

EIP applications will not consist solely 

of tower construction and modification. 

Accordingly, they have clarified the 

applicability of the program comment 

for multi-component proposals. 

NCSHPO was concerned about how 

this program comment would affect 

existing agreements. If, under the 

program comment, RUS and NTIA are 

not responsible for compliance with 

Section 106 for FCC regulated towers, 

then the trigger for existing agreements 

has been removed. 

USET explained to RUS and NTIA 

that it did not support expansion of the 

scope of the proposed program 

comment to all federal agencies. 

Accordingly, the proposal submitted to 

the ACHP applies to only NTIA and 

RUS. Finally, USET expressed concern 

that this process is being rushed and, as 

a consequence, tribes will not be 

allowed sufficient time to consult with 

agencies. However, the congressionally 

mandated Recovery Act schedules argue 

for an expedited process. 

III. Text of the proposed Program 

Comment 

The text of the proposed Program 

Comment is included below: 

Program Comment for Streamlining 

Section 106 Review for Wireless 

Communication Facilities Construction 

and Modification Subject To Review 

Under the FCC Nationwide 

Programmatic Agreement and/or the 

Nationwide Programmatic Agreement 

for the Collocation of Wireless 

Antennas 

I. Background: The Rural Utilities 

Service (RUS) and the National 

Telecommunications and Information 

Administration (NTIA) provide 

financial assistance to applicants for 

broadband deployment, which can 

involve the construction and placement 

of communications towers and 

antennas, and therefore RUS and NTIA 

must comply with Section 106 of the 

National Historic Preservation Act, 16 

U.S.C. 470f, and its implementing 

regulations at 36 CFR part 800 (Section 

106). Some of those communications 

towers and antennas are also regulated 

by the Federal Communications 

Commission (FCC), and therefore 

undergo, or are exempted from, Section 

106 review under the Nationwide 

Programmatic Agreement for Review of 

Effects on Historic Properties for Certain 

Undertakings Approved by the FCC 

(FCC Nationwide PA) and the 

Nationwide Programmatic Agreement 

for the Collocation of Wireless Antennas 

(FCC Collocation PA). The FCC 

Nationwide PA was executed by the 

FCC, the Advisory Council on Historic 

Preservation (ACHP), and the National 

Conference of State Historic 

Preservation Officers (NCSHPO) on 

October 4, 2004. The FCC Collocation 

PA was executed by the FCC, ACHP, 

and NCSHPO on March 16, 2001. The 

undertakings addressed by the FCC 

Nationwide PA primarily include the 

construction and modification of 

communication towers. The 

undertakings addressed by the FCC 


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Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices 47809 

Collocation PA include the collocation 

of communications equipment on 

existing structures and towers. 

This Program Comment is intended to 

streamline Section 106 review of the 

construction and modification of 

communication towers and antennas for 

which FCC and RUS or NTIA share 

Section 106 responsibility. 

Nothing in this Program Comment 

alters or modifies the FCC Nationwide 

PA or the FCC Collocation PA, or 

imposes Section 106 responsibilities on 

the FCC for elements of an RUS or NTIA 

undertaking that are unrelated to a 

communications facility within the 

FCC’s jurisdiction or are beyond the 

scope of the FCC Nationwide PA. 

II. Establishment and Authority: This 

Program Comment was issued by the 

ACHP on (date to be determined) 

pursuant to 36 CFR 800.14(e). 

III. Date of Effect: This Program 

Comment went into effect on (date to be 

determined). 

IV. Use of this Program Comment to 

Comply with Section 106 for the Effects 

of Facilities Construction or 

Modification Reviewed under the FCC 

Nationwide PA and/or the FCC 

Collocation PA: RUS and NTIA will not 

need to comply with Section 106 with 

regard to the effects of communication 

facilities construction or modification 

that has either undergone or will 

undergo Section 106 review, or is 

exempt from Section 106 review, by the 

FCC under the FCC Nationwide PA and/ 

or the FCC Collocation PA. For purposes 

of this program comment, review under 

the FCC Nationwide PA means the 

historic preservation review that is 

necessary to complete the FCC’s Section 

106 responsibility for an undertaking 

that is subject to the FCC Nationwide 

PA. 

When an RUS or NTIA undertaking 

includes both communications facilities 

construction or modification covered by 

the FCC Nationwide PA or Collocation 

PA and components in addition to such 

communication facilities construction 

or modification, RUS and NTIA will 

comply with Section 106 in accordance 

with the process set forth at 36 CFR 5 

800.3 through 800.7, or 36 CFR 800.8(c), 

or another applicable alternate 

procedure under 36 CFR 800.14, but 

will not have to consider the effects of 

the communication facilities 

construction or modification component 

of the undertaking on historic 

properties. Whenever RUS or NTIA uses 

this Program Comment for such 

undertakings, RUS or NTIA will apprise 

the relevant State Historic Preservation 

Officer (SHPO) or Tribal Historic 

Preservation Officer (THPO) of the use 

of this Program Comment for the 

relevant communication facilities 

construction or modification 

component. 

V. Amendment—The ACHP may 

amend this Program Comment after 

consulting with FCC, RUS, NTIA and 

other parties as appropriate, and 

publishing notice in the Federal 

Register to that effect. 

VI. Sunset Clause—This Program 

Comment will terminate on September 

30, 2015, unless it is amended to extend 

the period in which it is in effect. 

VII. Termination—The ACHP may 

terminate this Program Comment by 

publication of a notice in the Federal 

Register thirty (30) days before the 

termination takes effect. 

Authority: 36 CFR 800.14(e). 

Dated: September 10, 2009. 

John M. Fowler, 

Executive Director. 

[FR Doc. E9–22273 Filed 9–16–09; 8:45 am] 

BILLING CODE 4310–K6–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2009–0744] 

Certificate of Alternative Compliance 

for the Offshore Supply Vessel TYLER 

STEPHEN 

AGENCY: Coast Guard, DHS. 

ACTION: Notice. 

SUMMARY: The Coast Guard announces 

that a Certificate of Alternative 

Compliance was issued for the offshore 

supply vessel Tyler Stephen as required 

by 33 U.S.C. 1605(c) and 33 CFR 81.18. 

DATES: The Certificate of Alternative 

Compliance was issued on July 29, 

2009. 

ADDRESSES: The docket for this notice is 

available for inspection or copying at 

the Docket Management Facility (M–30), 

U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find this docket on the Internet by going 

to http://www.regulations.gov, inserting 

USCG–2009–0744 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, call 

CWO2 David Mauldin, District Eight, 

Prevention Branch, U.S. Coast Guard, 

telephone 504–671–2153. If you have 

questions on viewing or submitting 

material to the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

The offshore supply vessel Tyler 

Stephen will be used for offshore supply 

operations. Full compliance with 72 

COLREGS and the Inland Rules Act will 

hinder the vessel’s ability to maneuver 

within close proximity of offshore 

platforms. Due to the design of the 

vessel, it would be difficult and 

impractical to build a supporting 

structure that would put the side lights 

within 5.4’ from the greatest breadth of 

the Vessel, as required by Annex I, 

paragraph 3(b) of the 72 COLREGS and 

Annex I, Section 84.05(b), of the Inland 

Rules Act. Compliance with the rule 

would cause the lights on the offshore 

supply vessel Tyler Stephen to be in a 

location which will be highly 

susceptible to damage from offshore 

platforms. The offshore supply vessel 

Tyler Stephen cannot comply fully with 

lighting requirements as set out in 

international regulations without 

interfering with the special function of 

the vessel (33 U.S.C. 1605(c); 33 CFR 

81.18). 

Locating the side lights 6′– 95⁄8’’ 

inboard from the greatest breadth of the 

vessel on the pilot house will provide a 

shelter location for the lights and allow 

maneuvering within close proximity to 

offshore platforms. 

In addition, the horizontal distance 

between the forward and aft masthead 

lights may be 23′–1 1⁄8’’. Placing the aft 

masthead light at the horizontal 

distance from the forward masthead 

light as required by Annex I, paragraph 

3(a) of the 72 COLREGS, and Annex I, 

Section 84.05(a) of the Inland Rules Act, 

would result in an aft masthead light 

location directly over the aft cargo deck, 

where it would interfere with loading 

and unloading operations. 

The Certificate of Alternative 

Compliance allows for the placement of 

the side lights to deviate from 

requirements set forth in Annex I, 

paragraph 3(b) of 72 COLREGS, and 

Annex I, paragraph 84.05(b) of the 

Inland Rules Act. In addition the 

Certificate of Alternative Compliance 

allows for the horizontal separation of 

the forward and aft masthead lights to 

deviate from the requirements of Annex 

I, paragraph 3(a) of 72 COLREGS, and 

Annex I, Section 84.05(a) of the Inland 

Rules Act. 

This notice is issued under authority 

of 33 U.S.C. 1605(c), and 33 CFR 81.18. 


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