1180 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 

hearing request filed by D.M. Graham 

Laboratories, Inc., was withdrawn on 

December 10, 2009. D.M. Graham 

Laboratories was previously acquired by 

Mallinckrodt, Inc., which is now part of 

Covidien, 172 Railroad Ave., Hobart, NY 

13788. Teva Pharmaceuticals, the 

successor-in-interest to Sidmak 

Laboratories, withdrew its hearing 

request on February 15, 2010. Acura 

Pharmaceutical Co., 616 N. North Court, 

Palantine, IL 60067, successor to Halsey 

Drug Co., withdrew its hearing request 

on November 23, 2010. 

FDA sent a letter to Merz 

Pharmaceuticals, LLC, P.O. Box 18806, 

Greensboro, NC 27419, successor to 

Mayrand, Inc., Pharmaceuticals, on 

November 16, 2010, requesting that this 

company withdraw or affirm its 

outstanding hearing request under this 

docket within 30 days. As of December 

13, 2010, the company had not 

responded to FDA. 

FDA was unable to find current 

contact information for American 

Therapeutics, Amide Pharmaceutical, 

Inc., Bay Laboratories, Inc., National 

Pharmaceutical Manufacturing Co., 

Pharmaceutical Basics, Inc., 

Superpharm Corp., and United States 

Trading Corp. FDA did not receive any 

response to its attempt to contact 

Carnrick Laboratories, a subsidiary of 

Elan Corporation; Copley 

Pharmaceutical, Inc.; LuChem 

Pharmaceuticals, Inc.; Pioneer 

Pharmaceuticals, Inc.; Quantum 

Pharmics, Ltd.; or Upsher-Smith 

Laboratories, Inc. If any of these 

companies, or their successors-ininterest, continue to have an interest in 

pursuing their hearing requests under 

this docket, the companies (or their 

successors-in-interest) must affirm their 

hearing requests in writing by the date 

specified in this notice. FDA will 

assume that hearing requests that are 

not affirmed within that time frame are 

no longer being pursued, and will deem 

them withdrawn. 

III. Discontinued Products 

Some firms may have previously 

discontinued the manufacturing or 

distribution of products covered by this 

notice without removing them from the 

listing of their products under section 

510(j) of the FD&C Act. Other firms may 

discontinue manufacturing or marketing 

listed products in response to this 

notice. Firms that wish to notify the 

agency of product discontinuation 

should send a letter, signed by the firm’s 

chief executive officer, fully identifying 

the discontinued product(s), including 

NDC number(s), and stating that the 

product(s) has (have) been 

discontinued. The letter should be sent 

to Sakineh Walther (see ADDRESSES). 

Firms should also update the listing 

of their products under section 510(j) of 

the FD&C Act to reflect discontinuation 

of unapproved products. FDA plans to 

rely on its existing records, including 

drug listing records or other available 

information, when it targets violations 

for enforcement action. Firms should be 

aware that, after the effective date of this 

notice, FDA intends to take enforcement 

action without further notice against 

any firm that manufactures or ships in 

interstate commerce any unapproved 

product covered by this notice that is 

not the subject of an ongoing DESI 

proceeding. 

IV. Reformulated Products 

Some of the active ingredients found 

in drug products covered by this notice 

are included in the OTC monograph in 

part 341 (21 CFR part 341), ‘‘Cold, 

Cough, Allergy, Bronchodilator, and 

Antihistamine Drug Products for Overthe-Counter Human Use.’’ OTC products 

that comply with this monograph may 

be marketed without approval. 

However, FDA cautions firms against 

reformulating products into OTC 

products or different unapproved new 

drugs that are marketed under the same 

name or substantially the same name 

(including a new name that contains the 

old name). Reformulated products 

marketed under a name previously 

identified with a different active 

ingredient or combination of active 

ingredients have the potential to 

confuse health care practitioners and 

harm patients. 

This notice is issued under the 

Federal Food, Drug, and Cosmetic Act 

(sections 502 and 505 (21 U.S.C. 352 

and 355), and under authority delegated 

to the Assistant Commissioner for 

Policy under section 1410.21 of the FDA 

Staff Manual Guide. 

Dated: January 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–104 Filed 1–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0247] 

FDA Transparency Initiative: Improving 

Transparency to Regulated Industry 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; request 

for comments. 

SUMMARY: As part of the third phase of 

the Transparency Initiative, the Food 

and Drug Administration (FDA) is 

announcing the availability of a report 

entitled ‘‘FDA Transparency Initiative: 

Improving Transparency to Regulated 

Industry.’’ The report includes 19 action 

items and 5 draft proposals to improve 

transparency to regulated industry. FDA 

is seeking public comment on the 

content of the draft proposals, as well as 

on which draft proposals should be 

given priority. 

DATES: Submit electronic or written 

comments by March 8, 2011. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets at the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Ann 

Witt, Office of Policy, Planning, and 

Budget, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg 32, 

rm. 4226, Silver Spring, MD 20993, 

301–796–7463, FAX: 301–847–8616, email: Ann.Witt@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on the FDA 

Transparency Initiative 

In January 2009, President Obama 

issued a memorandum on Transparency 

and Open Government calling for an 

‘‘unprecedented level of openness in 

Government’’ and directing the Director 

of the Office of Management and Budget 

(OMB) to issue an Open Government 

Directive instructing executive 

departments and agencies to take 

specific actions to implement the 

principles of transparent, collaborative, 

and participatory government. The 

Open Government Directive was issued 

December 8, 2009. Under the leadership 

of Secretary of Health and Human 

Services, Kathleen Sebelius, the U.S. 

Department of Health and Human 

Services has also prioritized 

transparency and openness. In June 

2009, the Commissioner of Food and 

Drugs (the Commissioner), Dr. Margaret 

Hamburg, launched FDA’s 

Transparency Initiative to implement 

these efforts at FDA. 

The initiative is overseen by a Task 

Force representing key leaders of FDA. 

The internal Task Force is chaired by 

the Principal Deputy Commissioner of 

FDA and includes five of the Agency’s 


jdjones on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 1181 

1Transcripts and the webcast from both public 

meetings are available on the FDA Web site, http:// 

www.fda.gov/transparency. 

center directors, the Chief Counsel, the 

Associate Commissioner of Regulatory 

Affairs, and the Chief Scientist. The 

Task Force is charged with submitting a 

written report to the Commissioner on 

the Task Force’s findings and 

recommendations. 

The Task Force has held two public 

meetings,1 launched an online blog 

(http://fdatransparencyblog.fda.gov/), 

and opened a docket. The online blog 

and the docket received over 1,500 

comments. The blog, which is ongoing, 

has offered an opportunity for exchange 

about specific ideas for transparency at 

the Agency. 

The Task Force is proceeding with the 

Transparency Initiative in three phases: 

• Phase I: FDA Basics. 

• Phase II: Public Disclosure. 

• Phase III: Transparency to 

Regulated Industry. 

Phase I is intended to provide the 

public with basic information about 

FDA and how the Agency does its work. 

In early January 2010, FDA launched a 

Web-based resource called FDA Basics 

(http://www.fda.gov/fdabasics). The 

resource now includes (1) 158 questions 

and answers about FDA and the 

products that the Agency regulates, (2) 

9 short videos that explain various FDA 

activities, and (3) 14 conversations with 

FDA officials about the work of their 

offices. Each month, senior officials 

from FDA product centers and offices 

host online sessions about a specific 

topic and answer questions from the 

public about that topic. FDA uses the 

feedback provided by the public to 

update this resource. 

Phase II relates to FDA’s proactive 

disclosure of information the Agency 

has in its possession, and how to make 

information about Agency activities and 

decisionmaking more transparent, 

useful, and understandable to the 

public, while appropriately protecting 

confidential information. On May 19, 

2010, FDA released a report that 

contains 21 draft proposals about 

expanding the disclosure of information 

by FDA while maintaining 

confidentiality for trade secrets and 

individually identifiable patient 

information. 

The Task Force solicited comment on 

the content of the proposals, as well as 

on which draft proposals should be 

given priority, for 60 days. The Task 

Force is reviewing the comments 

received and will recommend specific 

proposals to the Commissioner for 

consideration. The Task Force’s 

recommendations will consider 

feasibility and priority, considering 

other Agency priorities that require 

resources. Not all of these proposals will 

necessarily be implemented. Some may 

require changes in law or regulation; 

some may require a substantial amount 

of resources. 

Phase III is the subject of this 

document and is described in more 

detail in section II of this document. 

II. Phase III: Transparency to Regulated 

Industry 

The third phase of the Transparency 

Initiative addresses ways FDA can 

become more transparent to regulated 

industry to foster a more efficient and 

cost-effective regulatory process. 

Regulated industry provides the 

public with food, drugs, medical 

devices, cosmetics, and other widely 

used and important consumer products. 

FDA’s mission is to protect and promote 

the public health through oversight of 

these products. 

In order to succeed, FDA must clearly 

communicate standards and 

expectations to industry. 

Communicating requirements and 

expectations to industry in a more 

accessible manner promotes 

understanding of, and compliance with, 

rules set up to protect the supply of food 

and medical products. 

In response to a request for input from 

FDA on this topic in March 2010 (75 FR 

11893, March 12, 2010), regulated 

companies requested additional 

transparency about the standards to 

which their products are held, the 

process for soliciting guidance from the 

Agency, and the progress of regulatory 

efforts at the Agency. In the report, FDA 

outlines 19 action items and 5 draft 

proposals to improve transparency to 

regulated industry. 

The Task Force is soliciting comment 

on the content of the five draft 

proposals, as well as on which draft 

proposals should be given priority, for 

60 days. After considering public 

comment on the draft proposals, the 

Task Force will recommend specific 

proposals to the Commissioner for 

consideration. FDA will begin to 

implement the action items in the report 

in 2011. 

III. Request for Comments 

FDA is interested in receiving 

comments from the public about the 

content of the five draft proposals as 

well as on which draft proposals should 

be given priority. Interested persons 

may submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments 

regarding this document. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Identify the draft proposal 

which your comment addresses by the 

number assigned to that proposal. 

Received comments may be seen in the 

Division of Dockets Management 

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

through Friday. 

Dated: January 1, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–71 Filed 1–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Oncologic 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: Oncologic 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 February 8, 2011, from 8 a.m. 

to 5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You’’, click 

on ‘‘White Oak Conference Center 

Parking and Transportation Information 

for FDA Advisory Committee Meetings’’. 

Please note that visitors to the White 

Oak Campus must enter through 

Building 1. 

Contact Person: Nicole Vesely, 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: 301–847–8532, email: 

nicole.vesely@fda.hhs.gov, or FDA 


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