76888 Federal Register / Vol. 79, No. 246 / Tuesday, December 23, 2014 / Rules and Regulations 

and 211(a) of the Advisers Act [15 

U.S.C. 80b–6a and 80b–11(a)]. 

List of Subjects in 17 CFR Part 275 

Investment advisers, Reporting and 

recordkeeping requirements. 

Text of Rule Amendment 

For the reasons set out in the 

preamble, Title 17, Chapter II of the 

Code of Federal Regulations is amended 

as follows. 

PART 275—RULES AND 

REGULATIONS, INVESTMENT 

ADVISERS ACT OF 1940 

■ 1. The authority citation for Part 275 

continues to read in part as follows: 

Authority: 15 U.S.C. 80b–2(a)(11)(G), 80b– 

2(a)(11)(H), 80b–2(a)(17), 80b–3, 80b–4, 80b– 

4a, 80b–6(4), 80b–6a, and 80b–11, unless 

otherwise noted. 

* * * * * 

§ 275.206(3)–3T [Amended] 

■ 2. In § 275.206(3)–3T, amend 

paragraph (d) by removing the words 

‘‘December 31, 2014’’ and adding in 

their place ‘‘December 31, 2016.’’ 

By the Commission. 

Dated: December 17, 2014. 

Brent J. Fields, 

Secretary. 

[FR Doc. 2014–29975 Filed 12–22–14; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 316 

[Docket No. FDA–2011–N–0583] 

Policy on Orphan-Drug Exclusivity; 

Clarification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification; clarification on 

policy. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing this 

document to clarify its policy regarding 

certain aspects of orphan-drug 

exclusivity. This document is being 

published because of a recent court 

decision interpreting provisions of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act), as amended by the 

Orphan Drug Act. 

DATES: Effective December 23, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Gayatri R. Rao, Office of Orphan 

Products Development, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5271, Silver Spring, 

MD 20993, 301–796–8660. 

SUPPLEMENTARY INFORMATION: 

I. Background 

After a designated orphan drug is 

approved, section 527 of the FD&C Act 

(21 U.S.C. 360cc) generally prohibits the 

Food and Drug Administration (FDA or 

the Agency) from approving another 

such drug for the same disease for 7 

years. Regulations interpreting this 

provision were proposed in 1991 

(January 29, 1991, 56 FR 3338) and 

made final in 1992 (December 29, 1992, 

57 FR 62076). In 2011, FDA issued a 

proposed rule (October 19, 2011, 76 FR 

64868) to amend these regulations to 

clarify certain regulatory language and 

propose areas of minor improvement 

regarding orphan-drug designation and 

orphan-drug exclusivity; these were 

finalized in 2013 (June 12, 2013, 78 FR 

35117). These regulations are codified 

under part 316 (21 CFR part 316). 

FDA has interpreted section 527 of 

the FD&C Act and its regulations such 

that the Agency will not recognize 

orphan-drug exclusivity for a drug when 

it has previously approved the same 

drug for the same use or indication in 

a rare disease or condition. 

§§ 316.3(b)(12); 316.31(a). A drug will 

not be considered the same as a 

previously approved drug if, at the time 

of approval, the sponsor has provided 

evidence that its drug is ‘‘clinically 

superior’’ to the previously approved 

drug, that is, the drug is more effective, 

safer, or makes a major contribution to 

patient care. § 316.3(b)(3). Accordingly, 

the sponsor of an orphan-designated 

drug that is the same as a previously 

approved drug, as defined in 

§ 316.3(b)(14), is required to 

demonstrate that its drug is clinically 

superior to the previously approved 

drug in order for its drug to be eligible 

for orphan-drug exclusivity upon 

approval. 

The Agency’s interpretation of section 

527 of the FD&C Act has been the 

subject of legal action in Depomed v. 

HHS et al., Civil Action No. 12–1592 

(KBJ) (D.D.C. September 5, 2014). 

Depomed has not demonstrated that 

GRALISE (gabapentin) is clinically 

superior to a previously approved drug, 

Pfizer’s NEURONTIN (gabapentin). 

Accordingly, under the relevant 

regulations, GRALISE is the same drug 

as NEURONTIN, because it contains the 

same active moiety (gabapentin), was 

approved for the same use (postherpetic neuralgia), and was not 

demonstrated to be clinically superior to 

NEURONTIN. Nevertheless, the 

Depomed court held that FDA must 

recognize orphan-drug exclusivity for 

GRALISE for the treatment of postherpetic neuralgia. Following the 

Depomed decision, under the court’s 

order, FDA recognized orphan-drug 

exclusivity for GRALISE for the 

treatment of post-herpetic neuralgia. 

II. Orphan-Drug Exclusivity 

In consideration of any uncertainty 

created by the court’s decision in 

Depomed, the Agency is issuing this 

statement. It is the Agency’s position 

that, given the limited terms of the 

court’s decision to GRALISE, FDA 

intends to continue to apply its existing 

regulations in part 316 to orphan-drug 

exclusivity matters. FDA interprets 

section 527 of the FD&C Act and its 

regulations (both the older regulations 

that still apply to original requests for 

designation made on or before August 

12, 2013, as well as the current 

regulations) to require the sponsor of a 

designated drug that is the ‘‘same’’ as a 

previously approved drug to 

demonstrate that its drug is ‘‘clinically 

superior’’ to that drug upon approval in 

order for the subsequently approved 

drug to be eligible for orphan-drug 

exclusivity. 

Dated: December 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29920 Filed 12–22–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

25 CFR Part 151 

[K00103 14/15 A3A10; 134D0102DR– 

DS5A300000–DR.5A311.IA000115] 

RIN 1076–AF23 

Land Acquisitions in the State of 

Alaska 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Final rule. 

SUMMARY: This rule deletes a provision 

in the Department of the Interior’s landinto-trust regulations that excludes from 

the scope of the regulations, with one 

exception, land acquisitions in trust in 

the State of Alaska. 

DATES: This rule is effective January 22, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Appel, Director, Office of 

Regulatory Affairs & Collaborative 

Action, (202) 273–4680; 

elizabeth.appel@bia.gov. 


tkelley on DSK3SPTVN1PROD with RULES