Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 60767 

SYSTEM MANAGER(S) AND ADDRESS: 

Director, Division of Practitioner Data 

Banks, Bureau of Health Professions, 

Health Resources and Services 

Administration, Room 8–103, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

Maryland 20857. 

NOTIFICATION PROCEDURE: 

Information is available upon request, 

to the persons or entities, or to the 

authorized agents in such form or 

manner as the Secretary prescribes. The 

subject of a report is notified via U.S. 

mail when a record concerning the 

individual is submitted to the Data Bank 

via Subject Notification Document 

(SND). 

REQUESTS BY MAIL: 

Practitioners may submit a ‘‘Request 

for Information Disclosure’’ to the 

address under system location for any 

report on themselves. The request must 

contain the following: Name, address, 

date of birth, gender, Social Security 

Number (optional), professional schools 

and years of graduation, and the 

professional license(s). For license, 

include: The license number, the field 

of licensure, the name of the State or 

Territory in which the license is held, 

and DEA registration number(s). The 

practitioner must submit a signed and 

notarized self-query request. 

PENALTIES FOR VIOLATION: 

Submitting a request under false 

pretenses is a criminal offense and 

subject to a civil monetary penalty of up 

to $11,000 for each violation. 

REQUESTS IN PERSON: 

Due to security considerations, the 

Data Bank cannot accept requests in 

person. 

REQUEST BY TELEPHONE: 

Practitioners may provide all of the 

identifying information stated above to 

the Data Bank Customer Service Center 

operator. Before the data request is 

fulfilled, the operator will return a 

paper copy of this information for 

verification, signature and notarization. 

RECORD ACCESS PROCEDURES: 

Request for access of records in the 

Data Bank may be completed online at: 

http://www.npdb-hipdb.hrsa.gov. The 

requests are submitted over the web 

using the Integrated Query and 

Reporting Service (IQRS), Query and 

Reporting Extensible Markup Language 

Service (QRXS), Interface Control 

Document (ICD) Transfer Program (ITP) 

or the Proactive Disclosure Service 

(PDS). Self-query, as described 

previously, may be initiated via the 

electronic system and is completed 

using the conventional mail system. 

Requesters, including self-queries, will 

receive an accounting of disclosure that 

has been made of their records, if any. 

CONTESTING RECORD PROCEDURES: 

The Data Bank routinely mails a copy 

of any report filed in it to the subject 

individual. A subject individual may 

contest the accuracy of information in 

the Data Bank concerning himself or 

herself and file a dispute. To dispute the 

accuracy of the information, the 

individual must contact the Data Bank 

and the reporting entity to: (1) Request 

for the reporting entity to file correction 

to the report; and (2) request the 

information be entered into a ‘‘disputed’’ 

status and submit a statement regarding 

the basis for the inaccuracy of the 

information in the report. If the 

reporting entity declines to change the 

disputed report or takes no actions, the 

subject may request that the Secretary of 

HHS review the disputed report. In 

order to seek a Secretarial Review, the 

subject must: (1) Provide written 

documentation containing clear and 

brief factual information regarding the 

information of the report; (2) submit 

supporting documentation or 

justification substantiating that the 

reporting entity’s information is 

inaccurate; and (3) submit proof that the 

subject individual has attempted to 

resolve the disagreement with reporting 

entity but was unsuccessful. The 

Department can only determine whether 

the report was legally required to be 

filed and whether the report accurately 

depicts the action taken and the 

reporter’s basis for action. Additional 

detail on the process of dispute 

resolution and Secretarial Review 

process can be found at 45 CFR § 60.14 

of the Data Bank regulations. 

RECORD SOURCE CATEGORIES: 

The records contained in the system 

are submitted by the following entities: 

(1) Insurance companies and others who 

have made payment as a result of a 

malpractice action or claim, (2) State 

Boards of Medical and Dental 

Examiners; (3) State Licensing Boards; 

(4) hospitals and other health care 

entities; (5) DEA; and (6) Federal 

entities which employ health 

practitioners or who have authority to 

sanction such practitioners covered by a 

Federal program. Section 1921 of the 

Social Security Act expands reporting of 

actions submitted by State health care 

practitioner licensing and certification 

authorities (including medical and 

dental boards), State entity licensing 

and certification authorities, peer 

review organizations and private 

accreditation organizations. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 2010–24568 Filed 9–30–10; 8:45 am] 

BILLING CODE 4160–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0506] 

Office of the Commissioner; Request 

for Comments on the Food and Drug 

Administration Fiscal Year 2011–2015 

Strategic Priorities Document; Request 

for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is seeking public 

comment on its draft Strategic Priorities 

FY 2011–2015. FDA has identified these 

strategic priorities and goals that will 

guide its efforts to achieve its public 

health mission. FDA is seeking public 

comment to help further refine these 

priorities and goals. 

DATES: Submit either electronic or 

written comments by November 1, 2010. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Darian Tarver, Office of Planning, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 4219, 

Silver Spring, MD 20993–0002, 301– 

796–4850. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is posting its draft Strategic 

Priorities FY 2011–2015 to ensure that 

key stakeholders are given an 

opportunity to comment on this 

document. 

The purpose of this document is to 

outline FDA’s strategic intentions and 

plans for the next 5 years (fiscal year 

(FY) 2011 through 2015). This 

document identifies four key crosscutting strategic priorities and four 

strategic program goals that will guide 

efforts to achieve FDA’s public health 

mission and to fulfill its role in 

supporting the larger mission and 

strategic goals of the Department of 


emcdonald on DSK2BSOYB1PROD with NOTICES
60768 Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 

1A ‘‘person’’ includes individuals, partnerships, 

corporations, or associations (section 201 of the 

Federal Food, Drug, and Cosmetic Act (the act) (21 

U.S.C. 321(e)). 

2Because the incidence of FMF in the United 

States is rare, Mutual sought and was granted 

orphan drug status for its product covered by NDA 

22–352 under section 526 of the act (21 U.S.C. 

360bb). The term ‘‘orphan drug’’ refers to a product 

that treats a rare disease affecting fewer than 

200,000 Americans. Enacted in 1983, the intent of 

the Orphan Drug Act is to stimulate the research, 

development, and approval of products that treat 

Health and Human Services. The four 

cross-cutting strategic priorities are: (1) 

Advance Regulatory Science and 

Innovation, (2) Strengthen the Safety 

and Integrity of the Global Supply 

Chain, (3) Strengthen Compliance and 

Enforcement Activities to Support 

Public Health, and (4) Expand Efforts to 

Meet the Needs of Special Populations. 

The four strategic program goals are: (1) 

Advance Food Safety and Nutrition, (2) 

Promote Public Health by Advancing 

the Safety and Effectiveness of Medical 

Products, (3) Establish an Effective 

Tobacco Regulation, Prevention, and 

Control Program, and (4) Manage for 

Organizational Excellence and 

Accountability. 

The strategic planning process is an 

opportunity for FDA to further refine 

and strengthen the strategic 

management structure currently in 

place. For comparison purposes, the 

current FDA Strategic Action Plan 2007 

can be viewed at http://www.fda.gov/ 

downloads/AboutFDA/Reports

ManualsForms/Reports/Strategic

ActionPlan/UCM061415.pdf. 

FDA has made significant progress in 

its strategic planning efforts. As we 

build on this progress we look forward 

to receiving your comments by (see 

DATES). The text of the draft strategic 

priorities document is available in a 

‘‘pdf’’ (portable document format) 

downloadable format through FDA’s 

Web site: http://www.fda.gov/ 

AboutFDA/. 

II. Comments 

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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: September 27, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24603 Filed 9–30–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0257] 

Single-Ingredient Oral Colchicine 

Products; Enforcement Action Dates 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or agency) is 

announcing its intention to take 

enforcement action against unapproved 

single-ingredient oral colchicine 

products and persons1 who manufacture 

or cause the manufacture of such 

products or their shipment in interstate 

commerce. Unapproved singleingredient oral colchicine products have 

been associated with serious adverse 

events, including fatalities. Singleingredient oral colchicine products are 

new drugs that require approved 

applications because they are not 

generally recognized as safe and 

effective. Currently one firm has 

obtained approved applications to 

market single-ingredient oral colchicine 

for the treatment of acute gout flares, 

prophylaxis of gout flares, and 

prophylaxis of attacks of Familial 

Mediterranean Fever (FMF). All other 

manufacturers who wish to market 

single-ingredient oral colchicine 

products for these or other indications 

must obtain FDA approval of a new 

drug application (NDA) or an 

abbreviated new drug application 

(ANDA). 

DATES: This notice is effective October 

1, 2010. For information about 

enforcement dates, see SUPPLEMENTARY

INFORMATION, section III.C. 

ADDRESSES: All communications in 

response to this notice should be 

identified with Docket No. FDA–2010– 

N–0257 and directed to the appropriate 

office listed as follows: 

Regarding applications under section 

505(b) of the Federal Food, Drug, and 

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

355(b)): Division of Anesthesia, 

Analgesia and Rheumatology Products, 

Office of New Drugs, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Silver Spring, 

MD 20993–0002. 

All other communications: See the 

FOR FURTHER INFORMATION CONTACT

section of this document. 

FOR FURTHER INFORMATION CONTACT: 

Karen Rothschild, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5237, 

Silver Spring, MD 20993–0002, 301– 

796–3689, e-mail: 

Karen.Rothschild@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Colchicine is an alkaloid of the 

Colchicum autumnale plant, also 

known as autumn crocus or meadow 

saffron. Colchicum was initially 

described in the 1st century A.D. by 

Dioscorides in the Materia Medica. 

Medical use of colchicum for gout pain 

dates back to the 6th century. It was 

used for several centuries, but the use of 

colchicum in the treatment of gout 

substantially declined by the 15th 

century because of its toxicity. 

Colchicum was reintroduced as a 

treatment for acute gout beginning in 

1763. Colchicine was first isolated from 

colchicum in 1820 and made available 

in oral dosage form during the 19th 

century. Colchicine in oral dosage form 

is currently marketed in the United 

States as approved and unapproved 

products, both as a single ingredient and 

in combination with probenecid. 

Colchicine for injection has been 

available in the United States since the 

1950s and has been administered 

intravenously for the treatment of acute 

gout flares. In the Federal Register of 

February 8, 2008 (73 FR 7565), FDA 

announced its intention to take 

enforcement action against unapproved 

drug products containing colchicine for 

injection. Single-ingredient oral 

colchicine products, the subject of this 

notice, have also been marketed in the 

United States without approved 

applications to treat acute gout flares, 

and are more commonly marketed in 

conjunction with uric acid lowering 

agents for the daily prophylaxis of flares 

of gout. Daily oral colchicine has also 

been the standard of care since the 

1970s for the prophylaxis of attacks of 

FMF. 

One firm, Mutual Pharmaceutical Co., 

Inc. (Mutual), of Philadelphia, PA, has 

received approval for three NDAs for 

single-ingredient oral colchicine. These 

approvals are: NDA 22–352 for the 

treatment of FMF,2 approved on July 29, 


emcdonald on DSK2BSOYB1PROD with NOTICES