17484 Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 

1This document addresses the information 

collection in current part 207. In the Federal 

Register of August 29, 2006 (the 2006 proposed 

rule) (71 FR 51276), FDA proposed to revise part 

207. The proposed revisions would reorganize, 

consolidate, clarify, and modify current regulations 

concerning who must register establishments and 

list, and describes when and how to register and list 

and what information must be submitted for 

registration and listing. In addition, the proposal 

would make certain changes to the National Drug 

Code (NDC) system and would require the 

appropriate NDC number to appear on the labels for 

drugs subject to the listing requirements. The 

proposed regulations generally also require the 

electronic submission of all registration and most 

listing information. The 2006 proposed rule 

requested comments on the information collection 

for revised part 207. When the proposal is finalized, 

the information collection for a revised part 207 

will replace the information collection in this 

document. 

to seek reclassification from a lower to 

a higher class, thereby increasing the 

regulatory requirements applicable to 

that device type. If approved, petitions 

requesting classification from class III to 

class II or class I provide an alternative 

route to market in lieu of premarket 

approval for class III devices. If 

approved, petitions requesting 

reclassification from class I or II, to a 

different class, may increase 

requirements. 

In the Federal Register of November 

14, 2011 (76 FR 70460), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

860.123 ................................................................................ 6 1 6 500 3,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on the last 3 years, and actual 

reclassification petitions received, FDA 

anticipates that six petitions will be 

submitted each year. The time required 

to prepare and submit a reclassification 

petition, including the time needed to 

assemble supporting data, averages 500 

hours per petition. This average is based 

upon estimates by FDA administrative 

and technical staff who: (1) Are familiar 

with the requirements for submission of 

a reclassification petition, (2) have 

consulted and advised manufacturers on 

these requirements, and (3) have 

reviewed the documentation submitted. 

Dated: March 20, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–7142 Filed 3–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0742] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Registration of 

Producers of Drugs and Listing of 

Drugs in Commercial Distribution 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 25, 

2012. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0045. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Registration of Producers of Drugs and 

Listing of Drugs in Commercial 

Distribution—21 CFR Part 207—(OMB 

Control Number 0910–0045)—Extension 

Requirements for drug establishment 

registration and drug listing are set forth 

in section 510 of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360); section 351 of the 

Public Health Service Act; and part 207 

(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-todate information is critical to 

conducting these activities with 

efficiency and effectiveness. 

Under section 510 of the FD&C Act, 

FDA is authorized to establish a system 

for registration of producers of drugs 

and for listing of drugs in commercial 

distribution. To implement section 510 

of the FD&C Act, FDA issued part 207.1

Under current § 207.20, manufacturers, 

repackers, and relabelers that engage in 

the manufacture, preparation, 

propagation, compounding, or 

processing of human or veterinary drugs 

and biological products, including bulk 

drug substances and bulk drug 

substances for prescription 

compounding, and drug premixes as 

well as finished dosage forms, whether 

prescription or over-the-counter, are 

required to register their establishment. 

In addition, manufacturers, repackers, 

and relabelers are required to submit a 

listing of every drug or biological 

product in commercial distribution. 

Owners or operators of establishments 

that distribute under their own label or 

trade name a drug product 

manufactured by a registered 

establishment are not required either to 

register or list. However, distributors 

may elect to submit drug listing 

information in lieu of the registered 

establishment that manufactures the 

drug product. Foreign drug 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 17485 

establishments must also comply with 

the establishment registration and 

product listing requirements if they 

import or offer for import their products 

into the United States. 

Under current § 207.21, 

establishments, both domestic and 

foreign, must register with FDA within 

5 days after beginning the manufacture 

of drugs or biologicals, or within 5 days 

after the submission of a drug 

application or biological license 

application (BLA). In addition, 

establishments must register annually. 

Changes in individual ownership, 

corporate or partnership structure, 

location, or drug-handling activity must 

be submitted as amendments to 

registration under current § 207.26 

within 5 days of such changes. Under 

§ 207.20(b), private label distributors 

may request their own labeler code and 

elect to submit drug listing information 

to FDA. In such instances, at the time 

of submitting or updating drug listing 

information, private label distributors 

must certify to the registered 

establishment that manufactured, 

prepared, propagated, compounded or 

processed (which includes, among other 

things, repackaging and relabeling) the 

listed drug that the drug listing 

submission was made. Establishments 

must, within 5 days of beginning the 

manufacture of drugs or biologicals, 

submit to FDA a listing for every drug 

or biological product in commercial 

distribution at that time. Private label 

distributors may elect to submit to FDA 

a listing of every drug product they 

place in commercial distribution. 

Registered establishments must submit 

to FDA drug product listing for those 

private label distributors who do not 

elect to submit listing information. 

Under § 207.25, product listing 

information submitted to FDA by 

domestic and foreign manufacturers 

must, depending on the type of product 

being listed, include any new drug 

application (NDA) number or biological 

establishment license number, copies of 

current labeling and a sampling of 

advertisements, a quantitative listing of 

the active ingredient for each drug or 

biological product not subject to an 

approved application or license, the 

NDC number, and any drug imprinting 

information. 

In addition to the product listing 

information required, FDA may also 

require, under § 207.31, a copy of all 

advertisements and a quantitative listing 

of all ingredients for each listed drug or 

biological product not subject to an 

approved application or license; the 

basis for a determination, by the 

establishment, that a listed drug or 

biological product is not subject to 

marketing or licensing approval 

requirements; and a list of certain drugs 

or biological products containing a 

particular ingredient. FDA may also 

request, but not require, the submission 

of a qualitative listing of the inactive 

ingredients for all listed drugs or 

biological products, and a quantitative 

listing of the active ingredients for all 

listed drugs or biological products 

subject to an approved application or 

license. 

Under § 207.30, establishments must 

update their product listing information 

every June and December or, at the 

discretion of the establishment, when 

any change occurs. These updates must 

include the following information: (1) A 

listing of all drug or biological products 

introduced for commercial distribution 

that have not been included in any 

previously submitted list; (2) all drug or 

biological products formerly listed for 

which commercial distribution has been 

discontinued; (3) all drug or biological 

products for which a notice of 

discontinuance was submitted and for 

which commercial distribution has been 

resumed; and (4) any material change in 

any information previously submitted. 

No update is required if no changes 

have occurred since the previously 

submitted list. 

Historically, drug establishment 

registration and drug listing information 

have been submitted in paper form 

using 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) (collectively 

referred to as FDA Forms). 

Changes in the FD&C Act resulting 

from enactment of the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85) (FDAAA) require 

that drug establishment registration and 

drug listing information be submitted 

electronically unless a waiver is 

granted. Before the enactment of 

FDAAA, section 510(p) of the FD&C Act 

expressly provided for electronic 

submission of drug establishment 

registration information upon a finding 

that electronic receipt was feasible, and 

section 510(j) of the FD&C Act provided 

that drug listing information be 

submitted in the form and manner 

prescribed by FDA. Section 224 of 

FDAAA, which amends section 510(p) 

of the FD&C Act, now expressly, 

requires electronic drug listing in 

addition to drug establishment 

registration. In certain cases, if it is 

unreasonable to expect a person to 

submit registration and listing 

information electronically, FDA may 

grant a waiver from the electronic 

format requirement. 

In the Federal Register of June 1, 2009 

(74 FR 26248), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Drug Establishment Registration and 

Drug Listing’’ (the 2009 guidance). The 

document provides guidance to industry 

on the statutory requirement to submit 

electronically drug establishment 

registration and drug listing 

information. The guidance describes the 

types of information to include for 

purposes of drug establishment 

registration and drug listing and how to 

prepare and submit the information in 

an electronic format (Structured Product 

Labeling (SPL) files) that FDA can 

process, review, and archive. 

In addition to the information that 

previously was collected by the FDA 

Forms, the guidance addresses 

electronic submission of other required 

information as follows: 

• For registered foreign drug 

establishments, the name, address, and 

telephone number of its U.S. agent 

(§ 207.40(c)); 

• The name of each importer that is 

known to the establishment (the U.S. 

company or individual in the United 

States that is an owner, consignee, or 

recipient of the foreign establishment’s 

drug that is imported into the United 

States. An importer does not include the 

consumer or patient who ultimately 

purchases, receives, or is administered 

the drug, unless the foreign 

establishment ships the drug directly to 

the consumer or the patient) (section 

510(i)(1)(A) of the FD&C Act); and 

• The name of each person who 

imports or offers for import (the name 

of each agent, broker, or other entity, 

other than a carrier, that the foreign 

drug establishment uses to facilitate the 

import of their drug into the United 

States) (section 510(i)(1)(A) of the FD&C 

Act). 

FDA also recommends the voluntary 

submission of the following additional 

information, when applicable: 

• To facilitate correspondence 

between foreign establishments and 

FDA, the email address for the U.S. 

agent, and the telephone number(s) and 

email address for the importer and 

person who imports or offers for import 

their drug; 

• A site-specific Data Universal 

Numbering System (DUNS) number for 

each entity (e.g., the registrant, 

establishments, U.S. agent, importer); 

• The NDC product code for the 

source drug that is repacked or 

relabeled; 


tkelley on DSK3SPTVN1PROD with NOTICES
17486 Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 

• Distinctive characteristics of certain 

listed drugs, i.e., the flavor, the color, 

and image of the actual solid dosage 

form; and 

• Registrants may indicate that they 

view as confidential the registrant’s 

business relationship with an 

establishment, or an inactive ingredient. 

In addition to the collection of 

information, there is additional burden 

for the following activities: 

• Preparing a standard operating 

procedure (SOP) for the electronic 

submission of drug establishment 

registration and drug listing 

information; 

• Creating the SPL file, including 

accessing and reviewing the technical 

specifications and instructional 

documents provided by FDA (accessible 

at http://www.fda.gov/oc/datacouncil/ 

spl.html); 

• Reviewing and selecting 

appropriate terms and codes used to 

create the SPL file (accessible at 

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

spl.html); 

• Obtaining the digital certificate 

used with FDA’s electronic submission 

gateway and uploading the SPL file for 

submission (accessible at http:// 

www.fda.gov/esg/default.htm); and 

• Requests for waivers from the 

electronic submission process as 

described in the draft guidance. 

When FDA published the 2009 

guidance on submitting establishment 

registration and drug listing information 

in electronic format, the Agency also 

amended its burden estimates for OMB 

control number 0910–0045 to include 

the additional burden for collection of 

information that had not been submitted 

using the FDA Forms, and to create and 

upload the SPL file. The amended 

burden estimates included the one-time 

preparation of an SOP for creating and 

uploading the SPL file. Although most 

firms will already have prepared an SOP 

for the electronic submission of drug 

establishment registration and drug 

listing information, each year additional 

firms will need to create an SOP. As 

provided in table 2 of this document, 

FDA estimates that approximately 1,000 

firms will have to expend a one-time 

burden to prepare, review, and approve 

an SOP, and the Agency estimates that 

it will take 40 hours per recordkeeper to 

create 1,000 new SOPs for a total of 

40,000 hours. The information 

collection requirements of the Drug 

Listing and Establishment Registration 

regulations have been grouped 

according to the information collection 

areas of the regulations. 

In the Federal Register of October 24, 

2011 (76 FR 65730), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment. 

Comment 

The comment raised two issues and 

asked for several procedural 

clarifications. The first issue raised 

suggested that the burden to industry 

might be greater than the 4.5-hour 

average provided in the estimate. The 

next issue questioned the process by 

which FDA issued a guidance to address 

the electronic submissions process 

without changing the regulation that 

still describes a paper submission 

process, which would have allowed for 

public comment on that change. The 

comment then sought several 

procedural clarifications on: (1) How to 

submit changes in ownership of an 

establishment, (2) how to select a 

business function, (3) how to ensure 

that an establishment is represented 

consistently between a vendor’s 

registration and the client’s drug 

establishment registration, (4) how to 

link an importer with a particular 

product, (5) how to list bulk tablets that 

will be imported for packaging, and (6) 

how to certify to the registered 

establishment that the private label 

distributor has listed the product. 

Response 

FDA acknowledges that the 2009 

guidance is different from the process 

described in the current part 207. As 

was stated in the Federal Register 

notice and as acknowledged by the 

commenter, the current regulation 

predates the electronic process and 

describes a paper-based submission 

process. FDA is in the process of 

rewriting part 207, and published the 

draft version for public comment in 

2006. Afterward, the FDAAA mandated 

the electronic submission of drug 

establishment and drug product 

information. The 2009 guidance was 

created to address the mandate of 

FDAAA. The 2006 proposed rule will be 

modified appropriately to address the 

FDAAA mandates as well. With regards 

to the estimated burden, FDA 

collaborated with members of industry 

and international health information 

data standards organizations to arrive at 

the current process and estimates for the 

burden of gathering, assembling, and 

submitting data. The estimates are 

considered to be averages that will vary 

up or down per individual respondent. 

The following paragraphs are 

intended to clarify one of the 

commenter’s issues mentioned 

previously in this document: 

1. Changes to the establishment name, 

registrant name, or other registration 

information can be made by submitting 

an updated registration submission via 

SPL. Changes in corporate ownership or 

officers that do not affect names, 

addresses, or the DUNS number(s) for a 

registered establishment should be 

made with Dun and Bradstreet. That 

data is then referenced as needed by 

FDA using the DUNS number. 

Information about submitting SPL can 

be found at the link at the end of the 

FDA response. It should be noted that 

changes in ownership may also require 

the submission of updates to listing 

information, labeler code name and 

DUNS, and application data for NDAs, 

abbreviated new drug applications 

(ANDAs), BLAs, new animal drug 

applications (NADAs), and abbreviated 

new animal drug applications 

(ANADAs). 

2. For selecting a business operation, 

a current list of valid business functions 

and their associated codes can be found 

at the link at the end of this response. 

Please note that if more than one 

business function apply, a registrant 

should select all that apply and include 

them in the registration SPL. 

3. FDA has implemented an 

automated validation of all drug product 

listing submissions to ensure that each 

establishment referenced in the product 

listing is registered under the same 

business operation. For example, a 

product listing SPL that references a 

particular facility as a packer of the 

product will be rejected if that 

establishment has not chosen Pack as a 

business operation in its registration. 

FDA expects vendors and clients to 

communicate this information directly 

to each other and, if necessary, 

coordinate their submissions in order to 

avoid issues with this validation. 

4. The importer information is 

submitted via the registration of the 

foreign establishment. Any product 

listing referencing that foreign 

establishment should therefore provide 

the necessary link from importer to 

product. Information about submitting 

SPL can be found at the link at the end 

of the FDA response. 

5. A product listing for bulk tablets 

intended for further processing or 

packaging should be listed using the 

SPL product/document type of Bulk 

Ingredient and a marketing category of 

Drug for Further Processing. Information 

about submitting SPL can be found at 

the link at the end of the FDA response. 

6. For finished dosage forms, 

appearance in the NDC Directory is 

proof of submission of listing. Note that 

unfinished products and active 

pharmaceutical ingredient listings will 

not appear in the NDC Directory. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 17487 

Instructions and SPL resources may 

be found on the SPL Resources Web 

page at http://www.fda.gov/ForIndustry/ 

DataStandards/ 

StructuredProductLabeling/default.htm 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

New registrations, including new labeler codes requests ... 39 14.72 574 4.5 2,583 

Annual updates of registration information .......................... 3,256 2.99 9,735 4.5 43,808 

New drug listings ................................................................. 1,567 6.57 10,295 4.5 46,328 

New listings for private label distributor ............................... 146 10.06 1,469 4.5 6,611 

June and December updates of all drug listing information 1,677 11.21 18,799 4.5 84,596 

Waiver requests ................................................................... 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 183,927 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity resulting from section 510(p) of the FD&C Act as 

amended by FDAAA 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

One-time preparation of SOP .............................................. 1,000 1 1,000 40 40,000 

SOP maintenance ................................................................ 3,295 1 3,295 1 3,295 

Total .............................................................................. ........................ ........................ ........................ ........................ 43,295 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: March 20, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7136 Filed 3–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Antiviral 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: Antiviral 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 May 11, 2012, from 8 a.m. to 5 

p.m. 

Location: DoubleTree by Hilton Hotel 

Washington DC/Silver Spring, The 

Ballrooms, 8727 Colesville Rd., Silver 

Spring, MD. The hotel telephone 

number is 301–589–5200. 

Contact Person: Yvette Waples, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, email: 

AVAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. 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 application (NDA) 203–100, 

for a fixed-dose combination tablet of 

elvitegravir/cobicistat/emtricitabine/ 

tenofovir disoproxil fumarate, submitted 

by Gilead Sciences, Inc. The application 

proposes an indication for the treatment 

of HIV–1 infection in adults who are 

antiretroviral naı ̈ve or have no known 

substitutions associated with resistance 

to the individual components. 

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/

AdvisoryCommittees/Calendar/default.

htm. 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 April 27, 2012. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making 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 April 19, 

2012. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 


tkelley on DSK3SPTVN1PROD with NOTICES