Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices 29337 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of Patents and 

Trademarks may award (half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a medical device will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(3)(B). 

FDA approved for marketing the 

medical devices, KDR 401 and 403 

PACEMAKERS. KDR 401 and 403 

PACEMAKERS are indicated for the 

following: Rate adaptive pacing in 

patients who may benefit from 

increased pacing rates concurrent with 

increases in activity and/or minute 

ventilation; accepted patient conditions 

warranting chronic cardiac pacing 

which include: symptomatic 

paroxysmal or permanent second or 

third-degree atrioventricular (AV) block; 

Symptomatic bilateral bundle branch 

block; symptomatic paroxysmal or 

transient sinus node dysfunctions with 

or without associated AV conduction 

disorders; bradycardia-tachycardia 

syndrome to prevent symptomatic 

bradycardia or some forms of 

symptomatic tachyarrhythmias; and 

vasovagal syndromes or hypersensitive 

carotid sinus syndromes. KDR 401 and 

403 PACEMAKERS are also indicated 

for dual chamber and atrial tracking 

modes in patients who may benefit from 

maintenance of AV synchrony. Dual 

chamber modes are specifically 

indicated for treatment of conduction 

disorders that require restoration of both 

rate and AV synchrony, which include: 

Various degrees of AV block to maintain 

the atrial contribution to cardiac output 

and vasovagal intolerance in the 

presence of persistent sinus rhythm. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for KDR 

401 and 403 PACEMAKERS (U.S. Patent 

No. 4,958,632) from Medtronic, Inc., 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

February 22, 2007, FDA advised the 

Patent and Trademark Office that these 

medical devices had undergone a 

regulatory review period and that the 

approval of KDR 401 and 403 

PACEMAKERS represented the first 

permitted commercial marketing or use 

of the products. Thereafter, the Patent 

and Trademark Office requested that 

FDA determine the products’ regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

KDR 401 and 403 PACEMAKERS is 716 

days. Of this time, 358 days occurred 

during the testing phase of the 

regulatory review period, while 358 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

360j(g)) involving this device became 

effective: February 16, 1996. The 

applicant claims that the investigational 

device exemption (IDE) required under 

section 520(g) of the act for human tests 

to begin became effective on May 21, 

1997. However, FDA records indicate 

that the IDE was determined 

substantially complete for clinical 

studies to have begun on February 16, 

1996, which represents the IDE effective 

date. 

2. The date the application was 

initially submitted with respect to the 

device under section 515 of the act (21 

U.S.C. 360e): February 7, 1997. The 

applicant claims February 6, 1997, as 

the date the premarket approval 

application (PMA) for KDR 401 and 403 

PACEMAKERS (PMA 970012) was 

initially submitted. However, FDA 

records indicate that PMA 970012 was 

submitted on February 7, 1997. 

3. The date the application was 

approved: January 30, 1998. FDA has 

verified the applicant’s claim that PMA 

970012 was approved on January 30, 

1998. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 358 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by July 24, 2007. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

November 21, 2007. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

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

Monday through Friday. 

Dated: May 7, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–10127 Filed 5–24–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0480] 

Draft Guidance for Industry on 

Complementary and Alternative 

Medicine Products and Their 

Regulation by the Food and Drug 

Administration; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, we) is 

announcing that it will consider 

comments submitted through May 29, 

2007, for a draft guidance for industry 

entitled ‘‘Complementary and 

Alternative Medicine Products and 

Their Regulation by the Food and Drug 

Administration.’’ Although the 

comment period for the draft guidance 

ended on April 30, 2007, we will 

consider comments submitted through 

May 29, 2007, due to confusion as to the 

closing date for comments on the draft 

guidance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance, submit written or electronic 

comments on the draft guidance by May 

29, 2007. 


jlentini on PROD1PC65 with NOTICES
29338 Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Philip L. Chao, Office of Policy and 

Planning (HF–23), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–0587. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of February 

27, 2007, (72 FR 8756), FDA announced 

the availability of a draft guidance for 

industry entitled ‘‘Complementary and 

Alternative Medicine Products and 

Their Regulation by the Food and Drug 

Administration.’’ The term 

‘‘complementary and alternative 

medicine’’ (CAM) encompasses a wide 

array of health care practices, products, 

and therapies that are distinct from 

practices, products, and therapies used 

in ‘‘conventional’’ or ‘‘allopathic’’

medicine. 

In recent years, the practice of 

complementary and alternative 

medicine CAM has increased in the 

United States, and we have seen 

increased confusion as to whether 

certain products used in CAM are 

subject to regulation under the Federal 

Food, Drug, and Cosmetic Act (the act) 

or Public Health Service Act (PHS Act). 

We have also seen an increase in the 

number of CAM products imported into 

the United States. Therefore, the draft 

guidance discusses when a CAM 

product is subject to the act or the PHS 

Act. 

The notice announcing the 

availability of the draft guidance 

provided a 60-day comment period, so 

the comment period for the draft 

guidance was scheduled to end on April 

30, 2007. Unfortunately, due to a 

typographical error in the draft guidance 

itself (which stated that the comment 

period would be 90 days from the date 

of the notice’s publication in the 

Federal Register), we became aware that 

some members of the public believed 

that the comment period would or 

should end on May 28 or May 29, 2007. 

This confusion was compounded by 

another error that appeared at one 

section of FDA’s Web site; the error, 

which appeared at the ‘‘Dockets Open 

for Comment’’ portion of the Web site 

where electronic comments are 

submitted, stated that the comment 

period would end on May 29, 2007. (In 

contrast, other sections of FDA’s Web 

site retained the April 30, 2007, date.) 

Given the amount of confusion as to 

the comment period, we are announcing 

that we will consider all comments on 

this draft guidance that are submitted 

through May 29, 2007. Previously 

submitted comments do not need to be 

resubmitted. 

Additionally, we are aware of 

considerable confusion about the 

content of the draft guidance, which has 

been widely misinterpreted. Therefore, 

we want consumers and CAM 

practitioners to understand that the 

draft guidance does not contain or 

propose any new regulatory 

requirements for any complementary 

and alternative medicine CAM product 

marketed in the United States and does 

not affect any state licensing 

requirements for any CAM practitioner 

or any consumer’s ability to buy or 

receive a CAM product or be treated by 

any CAM practitioner. 

Public concern based on 

misinterpretations of the draft guidance 

has generated a large volume of 

comments to the docket. The large 

volume of comments has impeded our 

ability to identify and respond to 

extension requests. Consequently, we 

are addressing those unanswered 

extension requests by considering 

comments submitted through May 29, 

2007. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the draft guidance. 

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 may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: May 22, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–2610 Filed 5–22–07; 3:21 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Application for the 

Pharmacology Research Associate 

Program 

Summary: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute of General Medical 

Sciences (NIGMS), the National 

Institutes of Health (NIH) will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: 

Application for the Pharmacology 

Research Associate Program. Type of 

Information Collection Request: 

Extension of a currently approved 

collection, OMB No. 0925–0378, 

expiration date August 31, 2007. Form 

Numbers: NIH 2721–1, NIH 2721–2. 

Need and Use of Information Collection: 

The Pharmacology Research Associate 

(PRAT) Program will use the applicant 

and referee information to award 

opportunities for training and 

experience in laboratory or clinical 

investigation to individuals with a Ph.D. 

degree in pharmacology or a related 

science, M.D., or other professional 

degree through appointments as PRAT 

Fellows at the National Institutes of 

Health or the Food and Drug 

Administration. The goal of the program 

is to develop leaders in pharmacological 

research for key positions in academic, 

industrial, and Federal research 

laboratories. Frequency of Response: 

Once a year. Affected Public: 

Individuals or households; Businesses 

or other for-profit. Type of Respondents: 

Applicants and Referees. 

The annual reporting burden is as 

follows: 


jlentini on PROD1PC65 with NOTICES