194 Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 

including policies involving food 

derived from biotechnology. 

Advises Center officials on regulatory 

approaches and manages the 

development of periodic plans for the 

Center’s regulation development 

activities. 

Develops legislative proposals related 

to food and cosmetic safety and defense; 

coordinates the Center’s review of bills 

and proposed legislation, upon request; 

and coordinates the Center’s technical 

assistance to Congressional or FDA 

Office of Legislation staff developing 

bills related to food and cosmetics, upon 

request. 

Manages the Center’s compliance 

with the Information Quality Act, 

including responses to request for 

correction and reconsideration 

submitted under the Act. 

Advises Center staff concerning the 

administrative procedures for 

rulemaking, guidelines, guidance 

documents, and other policy 

documents, hearings and delegations of 

authority. 

Leads the Center’s evaluation of 

existing regulations to determine 

whether they are efficiently or 

effectively accomplishing their intended 

purpose. 

Provides Center-level leadership and 

coordination regarding briefings with 

other parts of the Agency or Federal 

Government with clearance 

responsibility regarding CFSAN 

regulations and guidance documents, 

and other CFSAN documents subject to 

the Paperwork Reduction Act, in 

coordination with the Executive 

Operations Staff. 

Directs and manages Center programs 

involving the use of external scientific 

advisors, consultants, and committees. 

Counsels and coordinates with Center 

managers on the use of external 

scientific experts and resources. 

N. OFFICE OF NUTRITION, 

LABELING, AND DIETARY 

SUPPLEMENTS (DHK). The Office of 

Nutrition, Labeling, and Dietary 

Supplements (ONLDS): 

Primary responsibility for policy 

development and management of food 

and nutrition labeling, food standards, 

conventional foods, dietary 

supplements, and special nutritional 

(including infant formula and medical 

foods) food. 

Provides expert advice to the Center 

Director, other Deputy Directors, and 

other senior managers, and directs major 

Agency and Department nutrition and 

labeling initiatives and is the Delegate to 

national and international forums and 

conferences. 

Primary responsibility for policy and 

regulatory development and 

management of the food labeling 

program, including Nutrition Labeling 

and Education Act, Food Allergen 

Labeling and Consumer Protection Act 

and other Federal Food, Drug, and 

Cosmetic Act and Fair Packaging and 

Labeling Act labeling requirements. 

Provides scientific and technical 

review of and response to petitions and 

notifications related to all aspects of 

conventional food labeling. With the 

Office of Compliance, determines 

compliance with existing food standards 

and common or usual name regulations 

and issues temporary marketing permits 

to allow manufacturers to test market 

new foods. In addition, conducts 

scientific and technical review of 

enforcement and compliance materials 

including inspection reports, analytical 

reports and other pertinent records, and 

provides policy decisions on 

misbranding charges for all domestic 

and import actions, including infant 

formula and medical food 

manufacturers. 

Provides expert guidance for other 

Agency units and Federal and State 

officials and industry concerning 

regulatory requirements and compliance 

policies on food labeling (including 

infant formula and medical foods) and 

reviews proposed enforcement/ 

compliance actions referred by other 

agency units. 

Provides expert technical advice for 

participation in international forums. 

Reviews food product labeling 

(including infant formula, medical foods 

and nutrition labels) for adherence to 

regulations and appropriateness of 

claims and manages the Small Business 

Nutrition Labeling Exemption 

Notification Program. 

Provides scientific review and 

analysis of policies, regulations, 

research priorities, position papers, and 

advisory opinions on issues related to 

nutrition and nutrition labeling, and 

dietary guidance recommendations, and 

related nutrition science issues. 

Responsible for scientific and 

regulatory review of health claim 

petitions, qualified health claim 

petitions, nutrient content claim 

petitions, and FDA Modernization Act 

notifications for health claims and 

nutrient content claims. 

Provides expert advice and assistance 

to key officials and coordinates with 

other domestic and international 

scientific bodies on efforts related to 

nutrition and health. 

Identifies program priorities for, 

provides content design input to, and 

analysis of large-scale databases of food 

consumption, food composition, food 

ingredients, sales of processed packaged 

food products and product label 

information. Develops methods for 

monitoring US populations and special 

subgroups relative to use and safety of 

conventional foods and dietary 

supplements. 

Provides management and scientific 

review on issues related to infant 

formula, medical foods, and dietary 

supplements including petitions and 

notifications, and provides advice to key 

Agency components as well as 

international bodies. 

Responsible for the development of 

regulations, guidance, policy, programs, 

position papers and advisory opinions, 

and recommends research priorities for 

the management of the dietary 

supplement program, which includes 

safety assessments for the New Dietary 

Ingredient Notification Program, 

structure-function notifications, 

Certificates of Export, safety assessment 

for dietary supplement policy, 

responses to petitions and industryrelated notifications, post-market 

adverse event evaluations, and issues 

related to dietary supplement safety and 

nutrition. 

III. Delegations of Authority. Pending 

further delegation, directives, or orders 

by the Commissioner of the Food and 

Drugs, all delegations or re-delegations 

of authority to positions of the affected 

organizations in effect prior to this date 

shall continue in effect in them or their 

successors. 

Dated: December 20, 2007. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 07–6257 Filed 12–31–07; 8:45 am] 

BILLING CODE 4160–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0492] 

Guidance for Industry and Food and 

Drug Administration; Interactive 

Review for Medical Device 

Submissions: 510(k)s, Original PMAs, 

PMA Supplements, Original BLAs, and 

BLA Supplements; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Interactive Review for Medical Device 

Submissions: 510(k)s, Original PMAs, 

PMA Supplements, Original BLAs, and 

BLA Supplements.’’ The purpose of this 

guidance document is to recommend an 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 195 

interactive premarket review process for 

these submissions that is designed to 

expedite FDA’s review of device 

applications while continuing to assure 

device safety and effectiveness, in 

accordance with the goals of the Food 

and Drug Administration Amendments 

Act of 2007 (FDAAA). 

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidelines 

are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Interactive Review for Medical 

Device Submissions: 510(k)s, Original 

PMAs, PMA Supplements, Original 

BLAs, and BLA Supplements’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 240–276–3151. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this 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 either http:// 

www.fda.gov/dockets/ecomments or 

http://www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Samie Allen, Center for Devices and 

Radiological Health (HFZ–402), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4013. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the letter from the Secretary of 

Health and Human Services to the 

Chairman of the Committee on Health, 

Education, Labor, and Pensions of the 

Senate setting out the goals of the 

Medical Device User Fee Amendments 

of 2007 (MDUFA) (see section 201(c) of 

FDAAA), dated September 27, 2007, 

FDA committed to developing a 

guidance document that describes an 

interactive review process between FDA 

and industry for specific medical device 

premarket submissions. While FDA 

committed to developing an interactive 

review process only for premarket 

notification submissions (510(k)s), 

premarket approval applications 

(PMAs), and PMA supplements, the 

agency believes that medical device 

Biologic License Applications (BLAs) 

could also benefit from such a process. 

Therefore, the guidance document also 

applies to medical device BLAs and 

BLA supplements. 

The goal of the interactive review 

process is to improve the timeliness of 

the review process for 510(k)s, PMAs, 

PMA supplements, BLAs and BLA 

supplements. FDA expects that the 

interactive review process will result in 

prompter approvals and clearances of 

medical devices and thereby improve 

the public health. FDA intends to 

reassess the interactive review process 

on a regular basis to determine whether 

it is meeting its intended objectives. 

When necessary, changes will be 

implemented to improve the efficiency 

of this process. 

FDA is making this guidance 

document immediately in effect because 

prior public participation was not 

feasible or appropriate. In the letter 

described in section 201(c) of FDAAA 

that sets out the goals of MDUFA, FDA 

committed to developing, within 3 

months of the date of FDAAA’s 

enactment, a guidance document that 

describes an interactive review process. 

The interactive review process supports 

a less burdensome approach to the 

premarket review process that is 

consistent with public health. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the interactive 

review process for premarket medical 

device submissions. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. To receive ‘‘Interactive Review 

for Medical Device Submissions: 

510(k)s, Original PMAs, PMA 

Supplements, Original BLAs, and BLA 

Supplements,’’ you may either send an 

e-mail request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 240–

276–3151 to receive a hard copy. Please 

use the document number 1655 to 

identify the guidance you are 

requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions [including lists 

of approved applications and 

manufacturers’ addresses], small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

§§ 3501–3520) (the PRA). The 

collections of information in 21 CFR 

part 807, subpart E, have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814, subpart B, have been approved 

under OMB control number 0910–0231; 

and the collections of information in 21 

CFR part 601, subpart A, have been 

approved under OMB control number 

0910–0338. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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. 

Please note that in January 2008, the 

FDA website is expected to transition to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. After the transition 

date, electronic submissions will be 

accepted by FDA through the FDMS 

only. When the exact date of the 

transition to FDMS is known, FDA will 

publish a Federal Register notice 

announcing that date. 


pwalker on PROD1PC71 with NOTICES
196 Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 

Dated: December 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–6268 Filed 12–27–07; 3:08 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D– 0496] 

Draft Guidance for Industry on 

Questions and Answers Regarding the 

Labeling of Nonprescription Human 

Drug Products Marketed Without an 

Approved Application as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Questions and Answers Regarding the 

Labeling of Nonprescription Human 

Drug Products Marketed Without an 

Approved Application as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act.’’ This draft guidance is 

intended to assist industry in complying 

with the labeling requirements for 

nonprescription (over-the-counter 

(OTC)) human drugs marketed without 

an approved application established by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act. Separate guidance, 

issued by the Center for Food Safety and 

Applied Nutrition on labeling 

requirements for dietary supplements, is 

announced elsewhere in this issue of 

the Federal Register. 

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 comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance, including comments 

regarding proposed collection of 

information, by March 3, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed 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, addressStreet5630 

Fishers Lane, rm. 1061, 

placeCityRockville, StateMD 

PostalCode20852. Submit electronic 

comments to http://www.fda.gov/ 

dockets/ecomments or http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Walter Ellenberg, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5488, 

Silver Spring, MD 20993, 301–796–

2090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Questions and 

Answers Regarding the Labeling of 

Nonprescription Human Drug Products 

Marketed Without an Approved 

Application as Required by the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act.’’ On 

December 22, 2006, the President signed 

into law the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act (Public Law 109–462, 

120 Stat. 3469). This law amends the 

Federal Food, Drug, and Cosmetic Act 

(the act) with respect to serious adverse 

event reporting for dietary supplements 

and nonprescription drugs marketed 

without an approved application. The 

draft guidance document contains 

questions and answers relating to the 

new labeling requirements under Public 

Law 109–462 for OTC drugs marketed 

without an approved application. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on this topic. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the requirement 

of the applicable statutes and 

regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, 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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that in January 2008, the 

FDA Web site is expected to transition 

to the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. After the transition 

date, electronic submissions will be 

accepted by FDA through the FDMS 

only. When the exact date of the 

transition to FDMS is known, FDA will 

publish a Federal Register notice 

announcing that date. 

III. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501–

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth as follows. 

With respect to the following 

collection of information, FDA invites 

comment on the following: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection on respondents, including 

through the use of automated collection 

techniques, when appropriate, and other 

forms of information technology. 

Title: Labeling Requirements and 

Recommendations under the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act for 

Nonprescription Drug Products 

Marketed Without an Approved 

Application. 


pwalker on PROD1PC71 with NOTICES