Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices 26249 

listing information, unless a waiver is 

granted. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Office of Critical Path Programs (HF– 

18), Office of the Commissioner, Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

The guidance may also be obtained by 

mail by calling the Office of Critical 

Path Programs at 301–827–1512. Submit 

written comments on the 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.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Lonnie Smith, Office of Critical Path 

Programs (HF–18), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–0011. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Requirements for drug establishment 

registration and drug listing are set forth 

in section 510 of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360) and section 351 of the 

Public Health Service Act (the PHS Act) 

(42 U.S.C. 262) and 21 CFR part 207. 

Fundamental to FDA’s mission to 

protect the public health is the 

collection of this information, which is 

used for important activities such as 

postmarket surveillance for serious 

adverse drug reactions, inspection of 

drug manufacturing and processing 

facilities, and monitoring of drug 

products imported into the United 

States. Comprehensive, accurate, and 

up-to-date information is critical to 

conducting these activities with 

efficiency and effectiveness. 

Changes in the act, resulting from the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Public Law 110–85), require that drug 

establishment registration and drug 

listing information be submitted 

electronically, unless a waiver is 

granted. Before FDAAA was enacted, 

section 510(p) of the act expressly 

provided that drug establishment 

registration information must be 

submitted electronically, based on a 

finding that electronic receipt was 

feasible, and section 510(j) of the act 

stipulated that drug listing information 

must be submitted in the form and 

manner prescribed by FDA. Section 224 

of FDAAA, which amends section 

510(p) of the act, now expressly requires 

drug listing to be submitted by 

electronic means in addition to 

requiring electronic drug establishment 

registration. 

Drug establishment registration and 

drug listing information have, until 

now, been submitted using a paperbased format, i.e., Form FDA 2656 

(Registration of Drug Establishment/ 

Labeler Code Assignment), Form FDA 

2657 (Drug Product Listing), and Form 

FDA 2658 (Registered Establishments’ 

Report of Private Label Distributors). 

Moving from a paper-based format to an 

electronic system will improve the 

timeliness and accuracy of the 

submissions. 

This guidance is designed to assist 

manufacturers, repackers, and relabelers 

with electronic submissions of drug 

establishment registrations and drug 

listing information. The guidance and 

accompanying technical documents 

explain (among other things): 

• The statutory requirement to submit 

electronically drug establishment 

registration and drug listing 

information; 

• How to create a Structured Product 

Labeling (SPL) file for submitting drug 

establishment registration and drug 

listing information to FDA through the 

Electronic Submissions Gateway (ESG) 

using defined code sets and codes, i.e., 

a language recognized by the computer 

system; and 

• That FDA intends to no longer 

accept drug establishment registration 

and drug listing information in paper 

format, unless a waiver is granted. 

FDA encourages manufacturers, 

repackers, and relabelers to establish a 

gateway account as soon as possible so 

that they will be prepared to 

electronically submit drug 

establishment registration and drug 

listing information by June 1, 2009. 

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 providing regulatory 

submissions in electronic format for 

drug establishment registration and drug 

listing information. 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 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 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. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that 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 collection(s) of information 

in this guidance was approved under 

OMB control number 0910–0045. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/cder/guidance/index.htm, 

http://www.fda.gov/cber/ 

guidelines.htm, http://www.fda.gov/ 

cvm/guidance/guidance.html, and 

http://www.regulations.gov. 

Dated: May 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–12743 Filed 5–28–09; 4:15 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Advisory Committee for 

Pharmaceutical Science and Clinical 

Pharmacology; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Advisory 

Committee for Pharmaceutical Science 

and Clinical Pharmacology. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held August 4, 2009, from 8 a.m. to 5 

p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

26250 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589– 

5200. 

Contact Person: Janie Kim, Center for 

Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093) Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, email: 

Janie.kim@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572) in the 

Washington, DC area), code 

3014512539. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The committee will discuss 

bioequivalence recommendations for 

oral vancomycin hydrochloride capsule 

drug products. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

dockets/ac/acmenu.htm, click on the 

year 2009 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before July 21, 2009. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before July 13, 2009. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by July 14, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Janie Kim at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: May 20, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–12627 Filed 5–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Dermatologic and Ophthalmic Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Dermatologic 

and Ophthalmic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on June 26, 2009, from 8 a.m. to 5 

p.m. 

Location: Hilton Washington DC/ 

Silver Spring, Maryland Ballrooms, 

8727 Colesville Rd., Silver Spring, MD. 

The hotel phone number is 301–589– 

5200. 

Contact Person: Paul Tran, Center for 

Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, Rm. 1093) Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6778, e-mail: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512534. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The committee will discuss 

new drug applications (NDAs) 22–288, 

BEPREVE (bepotastine besilate) 

ophthalmic solution, 1.5%, ISTA 

Pharmaceuticals, Inc., proposed for the 

treatment of ocular itching associated 

with allergic conjunctivitis, and NDA 

22–358, sodium hyaluronate ophthalmic 

solution, 0.18%, River Plate 

Biotechnology, Inc., proposed for the 

treatment of the signs and symptoms of 

dry eye disease. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

dockets/ac/acmenu.htm, click on the 

year 2009 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before June 17, 2009. Oral 

presentations from the public will be 

scheduled between approximately 9:30 

a.m. to 10 a.m., and 1:30 p.m. to 2 p.m. 

Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed