66448 Federal Register / Vol. 71, No. 220 / Wednesday, November 15, 2006 / Rules and Regulations 

affected airports. Because of the close 

and immediate relationship between 

these SIAPs and/or Weather Takeoff 

Minimums and safety in air commerce, 

I find that notice and public procedure 

before adopting these SIAPs and/or 

Weather Takeoff Minimums are 

impracticable and contrary to the public 

interest and, where applicable, that 

good cause exists for making some 

SIAPs and/or Weather Takeoff 

Minimums effective in less than 30 

days. 

Conclusion 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. It, therefore—(1) is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. For the same 

reason, the FAA certifies that this 

amendment will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

List of Subjects in 14 CFR Part 97 

Air traffic control, Airports, 

Incorporation by reference, and 

Navigation (air). 

Issued in Washington, DC on November 3, 

2006. 

James J. Ballough, 

Director, Flight Standards Service. 

Adoption of the Amendment 

■ Accordingly, pursuant to the authority 

delegated to me, under Title 14, Code of 

Federal Regulations, part 97 (14 CFR 

part 97) is amended by establishing, 

amending, suspending, or revoking 

Standard Instrument Approach 

Procedures and Weather Takeoff 

Minimums effective at 0901 UTC on the 

dates specified, as follows: 

PART 97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40106, 

40113, 40114, 40120, 44502, 44514, 44701, 

44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

Effective 23 November 2006 

Jonesville, VA, Lee County, RNAV (GPS) 

RWY 7, Orig 

Jonesville, VA, Lee County, RNAV (GPS) 

RWY 25, Orig 

Jonesville, VA, Lee County, Takeoff 

Minimums and Textual DP, Orig 

Effective 21 December 2006 

Fort Myers, FL, Southwest Florida Intl, LOC 

RWY 5, Orig 

Effective 18 January 2007 

Greensboro, AL, Greensboro Muni, RNAV 

(GPS) RWY 18, Orig 

Greensboro, AL, Greensboro Muni, RNAV 

(GPS) RWY 36, Orig 

Greensboro, AL, Greensboro Muni, NDB OR 

GPS RWY 36, Orig-B, CANCELLED 

Greensboro, AL, Greensboro Muni, Takeoff 

Minimums and Textual DP, Orig 

Gulkana, AK, Gulkana, RNAV (GPS) RWY 15, 

Amdt 1 

Gulkana, AK, Gulkana, RNAV (GPS) RWY 33, 

Amdt 1 

Gulkana, AK, Gulkana, VOR/DME RWY 15, 

Orig 

Gulkana, AK, Gulkana, VOR/DME RWY 33, 

Orig 

Gulkana, AK, Gulkana, VOR RWY 14, Amdt 

7, CANCELLED 

Gulkana, AK, Gulkana, VOR RWY 32, Amdt 

6A, CANCELLED 

Gulkana, AK, Gulkana, DF RWY 15, Amdt 2 

Gulkana, AK, Gulkana, Takeoff Minimums & 

Textual DPs, Amdt 7 

Orlando, FL, Kissimmee Gateway, ILS OR 

LOC RWY 15, Orig 

Louisville, KY, Bowman Field, RNAV (GPS) 

RWY 24, Orig 

Louisville, KY, Bowman Field, GPS RWY 24, 

Orig-B, CANCELLED 

Brookhaven, MS, Brookhaven-Lincoln 

County, RNAV (GPS) RWY 22, Orig 

Brookhaven, MS, Brookhaven-Lincoln 

County, VOR/DME–A, Amdt 9 

Brookhaven, MS, Brookhaven-Lincoln 

County, NDB OR GPS RWY 22, Amdt 3, 

CANCELLED 

Great Falls, MT, Great Falls Intl, Takeoff 

Minimums and Textual DP, Orig 

Gastonia, NC, Gastonia Muni, RNAV (GPS) 

RWY 21, Orig 

Gastonia, NC, Gastonia Muni, RNAV (GPS) 

RWY 3, Amdt 1 

Dayton, OH, Greene County—Lewis A 

Jackson Regional, RNAV (GPS) RWY 7, 

Orig 

Dayton, OH, Greene County—Lewis A 

Jackson Regional, RNAV (GPS) RWY 25, 

Orig 

Dayton, OH, Greene County—Lewis A 

Jackson Regional, NDB RWY 25, Amdt 1 

Dayton, OH, Greene County—Lewis A 

Jackson Regional, GPS RWY 7, Orig-A, 

CANCELLED 

Dayton, OH, Greene County—Lewis A 

Jackson Regional, Takeoff Minimums and 

Textual DP, Amdt 1 

Elk City, OK, Elk City Regional Business, 

RNAV (GPS) RWY 17, Orig 

Elk City, OK, Elk City Regional Business, 

RNAV (GPS) RWY 35, Orig 

Elk City, OK, Elk City Regional Business, 

NDB RWY 17, Amdt 5 

Elk City, OK, Elk City Regional Business, 

VOR/DME RNAV RWY 17, Amdt 2A, 

CANCELLED 

Elk City, OK, Elk City Regional Business, 

GPS RWY 35, Orig, CANCELLED 

Elk City, OK, Elk City Regional Business, 

GPS RWY 17, Orig, CANCELLED 

Elk City, OK, Elk City Regional Business, 

Takeoff Minimums and Textual DP, Amdt 

1 

Fayetteville, TN, Fayetteville Muni, RNAV 

(GPS) RWY 20, Orig 

Fayetteville, TN, Fayetteville Muni, SDF 

RWY 20, Amdt 4 

Fayetteville, TN, Fayetteville Muni, GPS 

RWY 20, Orig-A, CANCELLED 

Olympia, WA, Olympia, VOR/DME RWY 35, 

Amdt 12 

Olympia, WA, Olympia, VOR–A, Amdt 1 

Olympia, WA, Olympia, RNAV (GPS) RWY 

35, Orig 

Olympia, WA, Olympia, RNAV (GPS) RWY 

17, Orig 

The FAA published an Amendment in 

Docket No. 30513, Amdt No. 3184 to Part 97 

of the Federal Aviation Regulations (Vol 71, 

FR No. 179, Page 54404; dated September 15, 

2006) under section 97.27, effective 23 

November 2006, published in TL 06–21 are 

hereby RESCINDED as follows: 

Saratoga, WY, Shively Field, NDB–A, Amdt 

1 

Saratoga, WY, Shively Field, RNAV (GPS)–B, 

Orig 

[FR Doc. E6–19112 Filed 11–14–06; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 203 and 205 

[Docket Nos. 1992N–0297 (Formerly 92N–

0297), 1988N–0258 (Formerly 88N–0258), 

2006D–0226] 

Prescription Drug Marketing Act 

Pedigree Requirements under 21 CFR 

Part 203 Compliance Policy Guide and 

Guidance for Industry: Prescription 

Drug Marketing Act Pedigree 

Requirements Questions and Answers; 

Notice of Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability of 

guidances. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a final Compliance Policy 

Guide (CPG) 160.900 entitled 

‘‘Prescription Drug Marketing Act—

Pedigree Requirements under 21 CFR 

Part 203’’ (PDMA CPG). This CPG 

describes how the agency intends to 

prioritize its enforcement efforts in the 

first year after the December 1, 2006, 

effective date of 21 CFR §§ 203.3(u) and 

203.50. In addition, the FDA is 

announcing the availability of 

‘‘Guidance for Industry: Prescription 

Drug Marketing Act (PDMA) Pedigree 


rmajette on PROD1PC67 with RULES1
Federal Register / Vol. 71, No. 220 / Wednesday, November 15, 2006 / Rules and Regulations 66449 

Requirements Questions and Answers’’

(PDMA Q & A). The PDMA Q & A 

guidance is issued in response to the 

many questions received regarding the 

Prescription Drug Marketing Act 

(PDMA) pedigree requirements. The two 

guidance documents explain FDA’s 

current thinking on issues related to the 

pedigree requirements of the PDMA. 

DATES: The effective date for the PDMA 

CPG is December 1, 2006. The PDMA 

CPG expires December 1, 2007. The 

PDMA Q & A guidance is effective 

November 15, 2006. Submit written or 

electronic comments on the PDMA Q & 

A guidance or the PDMA CPG at any 

time. 

ADDRESSES: Submit written comments 

on the PDMA Q & A guidance or the 

PDMA CPG identified by the docket 

numbers found in the heading of this 

document by any of the following 

methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

docket numbers for this rulemaking. All 

comments received may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

numbers, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ilisa 

Bernstein, Office of the Commissioner, 

Office of Policy (HF–11), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3360, or 

by e-mail ilisa.bernstein@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Implementation of 21 CFR 

§§ 203.3(u) and 203.50 

The PDMA, as modified by the 

Prescription Drug Amendments of 1992, 

amended sections 301, 303, 503, and 

801 of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 331, 

333, 353, and 381) to establish, among 

other things, requirements related to the 

wholesale distribution of prescription 

drugs. A primary purpose of the PDMA 

is to increase safeguards to prevent the 

introduction and retail sale of 

substandard, ineffective, and counterfeit 

drugs in the U.S. drug supply chain. 

Section 503(e)(1)(A) of the Federal 

Food, Drug, and Cosmetic Act (act) 

establishes the so-called ‘‘pedigree’’

requirement for prescription drugs. A 

drug pedigree is a statement of origin 

that identifies each prior sale, purchase, 

or trade of a drug, including the dates 

of those transactions and the names and 

addresses of all parties to them. Under 

the pedigree requirement, each person 

who is engaged in the wholesale 

distribution of a prescription drug in 

interstate commerce, who is not the 

manufacturer or an authorized 

distributor of record for that drug, must 

provide a pedigree for that drug to the 

person who receives the drug. The 

PDMA states that an authorized 

distributor of record is a wholesaler that 

has an ‘‘ongoing relationship’’ with a 

manufacturer to distribute that 

manufacturer’s drug. However, the 

PDMA does not define ‘‘ongoing 

relationship.’’

In 1999, FDA published final 

regulations related to the PDMA (part 

203 (21 CFR part 203)). The regulations 

were to take effect in December 2000. 

After publication of the 1999 final rule, 

the agency received comments objecting 

to the provisions in §§ 203.3(u) and 

203.50. Section 203.3(u) defines 

‘‘ongoing relationship’’ to include a 

written agreement between a 

manufacturer and a distributor. Section 

203.50 specifies the fields of 

information that must be included in 

the drug pedigree, and states that the 

information must be traceable back to 

the first sale by the manufacturer. Based 

on concerns raised by various 

stakeholders, the agency delayed the 

effective date of §§ 203.3(u) and 203.50 

several times. 

Most recently, in February 2004, FDA 

delayed the effective date of §§ 203.3(u) 

and 203.50 until December 1, 2006, in 

part because we were informed by 

stakeholders in the U.S. drug supply 

chain that the industry would 

voluntarily implement electronic track 

and trace technology by 2007. If widely 

adopted, this technology could create a 

de facto electronic pedigree (e-pedigree) 

documenting the sale of a drug product 

from its place of manufacture through 

the U.S. drug supply chain to the final 

dispenser. If properly implemented, an 

electronic record could thus meet the 

pedigree requirements in section 

503(e)(1)(A) of the act. Based on a recent 

fact-finding effort by FDA to assess the 

use of e-pedigree across the supply 

chain, however, it appears that industry 

will not fully implement track and trace 

technology by 2007. 

As a result of this fact finding, FDA 

published a notice in the Federal 

Register on June 14, 2006 (71 FR 34249), 

announcing that it does not intend to 

delay the effective date of §§ 203.3(u) 

and 203.50 beyond December 1, 2006. 

Thus, these provisions defining 

‘‘ongoing relationship’’ and setting forth 

requirements regarding the information 

that must appear in pedigrees will go 

into effect as of December 1, 2006. As 

part of its June 14, 2006, announcement, 

FDA also issued and requested 

comment on draft Compliance Policy 

Guide 160.900 entitled ‘‘Prescription 

Drug Marketing Act Pedigree 

Requirements under 21 CFR Part 203.’’

B. PDMA Compliance Policy Guide 

We are issuing the final PDMA CPG, 

which describes how we plan to 

prioritize our enforcement efforts during 

the first year in which §§ 203.3(u) and 

203.50 are effective. This PDMA CPG 

lists factors that FDA field personnel are 

expected to consider in prioritizing 

FDA’s pedigree related enforcement 

efforts. Consistent with our risk-based 

approach to the regulation of 

pharmaceuticals, utilizing these factors 

will focus our efforts on drug products 

that are most vulnerable to 

counterfeiting and diversion or that are 

otherwise involved in illegal activity. 

The priorities described in the PDMA 

CPG reflect a phased-in type approach 

to the enforcement of the previously 

stayed pedigree provisions. The PDMA 

CPG will expire December 1, 2007. By 

providing guidance on the types of 

drugs that are currently of greatest 


rmajette on PROD1PC67 with RULES1
66450 Federal Register / Vol. 71, No. 220 / Wednesday, November 15, 2006 / Rules and Regulations 

concern to FDA, we believe that 

wholesale distributors will have a better 

idea of where and how to focus their 

initial energies as they implement 

systems and approaches to come into 

complete compliance with 21 CFR part 

203. 

FDA is issuing this PDMA CPG as a 

level 1 guidance consistent with FDA’s 

good guidance practices (21 CFR 

§ 10.115). 

We note that guidance documents are 

not binding on FDA or industry, and, 

under appropriate circumstances, the 

agency may initiate regulatory action, 

including criminal prosecution, for 

violations of the pedigree requirements. 

C. Guidance for Industry: Prescription 

Drug Marketing Act Pedigree 

Requirements Questions and Answers 

We are also issuing the PDMA Q & A, 

which represents FDA’s current 

thinking on several issues regarding the 

PDMA pedigree requirements. It 

addresses numerous questions that FDA 

received as comments to the PDMA CPG 

docket, as well as through e-mail and 

other communications, regarding the 

PDMA pedigree requirements. The 

questions and answers in the guidance 

address issues pertaining to 

manufacturers, wholesale distributors, 

pharmacies, and other entities affected 

by the PDMA pedigree requirements. 

FDA is issuing the PDMA Q & A as 

a level 1 guidance consistent with 

FDA’s good guidance practices (21 CFR 

§ 10.115). Given that the relevant PDMA 

pedigree provisions will go into effect as 

of December 1, 2006, FDA is 

implementing the PDMA Q&A 

immediately, in accordance with 

§ 10.115(g)(2) (21 CFR 10.115(g)(2)), 

because the agency has determined that 

prior public input is not feasible or 

appropriate. As noted, the pedigree 

requirements set forth in §§ 203.3(u) and 

203.50, which had been stayed on 

several occasions, will apply to 

prescription drug products as of 

December 1, 2006. Promptly clarifying 

FDA’s current thinking on the questions 

in the guidance should facilitate 

industry’s compliance with the PDMA 

pedigree requirements. 

Under § 10.115(g), FDA is opening a 

docket on the PDMA Q & A, and we 

invite interested persons to submit 

comments and questions. FDA intends 

to review the comments and questions 

and to revise the PDMA Q & A when 

appropriate, using the question and 

answer format in the PDMA Q & A 

guidance. For purposes of transparency, 

efficiency, and clarity, the agency 

believes that, at the present time, it is 

important to maintain FDA’s written 

responses to the significant questions 

concerning the PDMA pedigree 

requirements in a single guidance 

document that is periodically updated 

as the agency receives and responds to 

additional questions. We also intend to 

use the following four indicators to help 

users of the guidance identify future 

additions or revisions: (1) The updated 

guidance will be identified as a revision 

of the previously issued document, (2) 

the revision date of the guidance will 

appear on its cover, (3) the edition 

number of the guidance will be 

included in its title, and (4) questions 

and answers that have been added to the 

guidance, or prior answers that have 

been in any way modified, will be 

identified as such in the body of the 

guidance. 

The PDMA CPG and PDMA Q & A 

guidance represent the agency’s current 

thinking on issues related to the PDMA 

pedigree requirements. The guidances 

do not create or confer any rights for or 

on any person and do not operate to 

bind FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Electronic Access 

An electronic version of the PDMA 

CPG is available on the Internet at 

http://www.fda.gov/ora under 

‘‘Compliance Reference’’. An electronic 

version of the PDMA Q & A guidance is 

available at http://www.fda.gov/pdma. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the PDMA Q & A 

guidance or PDMA CPG at any time. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments and the guidance may be 

seen in the Division of Dockets 

management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: November 8, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–9211 Filed 11–13–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF TRANSPORTATION 

Federal Highway Administration 

23 CFR Part 635 

[FHWA Docket No. FHWA–2006–23552] 

RIN 2125–AF18 

Construction and Maintenance 

AGENCY: Federal Highway 

Administration (FHWA), DOT. 

ACTION: Final rule. 

SUMMARY: The FHWA is revising its 

regulations in 23 CFR part 635 subpart 

D to address Section 5514 of the Safe, 

Accountable, Flexible, Efficient 

Transportation Equity Act: A Legacy for 

Users (SAFETEA–LU). This law requires 

the FHWA to ensure that States provide 

for competition with respect to the 

specification of alternative types of 

culvert pipes. These revisions will 

ensure that States provide for 

competition in the specification of 

alternative types of culvert pipes. 

DATES: Effective Date: December 15, 

2006. 

FOR FURTHER INFORMATION CONTACT: For 

technical information: Mr. Gerald 

Yakowenko, Office of Program 

Administration (HIPA), (202) 366–1562. 

For legal information: Mr. Michael 

Harkins, Office of the Chief Counsel 

(HCC–30), (202) 366–4928, Federal 

Highway Administration, 400 Seventh 

Street, SW., Washington, DC 20590. 

Office hours are from 7:45 a.m. to 4:15 

p.m., e.t., Monday through Friday, 

except Federal holidays. 

SUPPLEMENTARY INFORMATION: 

Electronic Access 

This document and all comments 

received by the U.S. DOT Dockets, 

Room PL–401, may be viewed through 

the Docket Management System (DMS) 

at http://dms.dot.gov. It is available 24 

hours each day, 365 days each year. 

Electronic submission and retrieval help 

and guidelines are available under the 

help section of this Web site. 

An electronic copy of this document 

may be downloaded from the Federal 

Register’s home page at http:// 

www.archives.gov and the Government 

Printing Office’s Web page at http:// 

www.access.gpo.gov/nara. 

Background 

Section 5514 of the SAFETEA–LU 

(Pub. L. 109–59; Aug. 10, 2005), titled 

‘‘Competition for Specification of 

Alternative Types of Culvert Pipes,’’

requires the Secretary of Transportation 

to ensure that States provide for 

competition with respect to the 


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