Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 62163 

Dated: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24599 Filed 10–15–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–1675] 

New Chemical Entity Exclusivity 

Determinations for Certain FixedCombination Drug Products; Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘New Chemical Entity 

Exclusivity Determinations for Certain 

Fixed-Combination Drug Products.’’ 

This guidance sets forth a change in the 

Agency’s interpretation of the 5-year 

new chemical entity (NCE) exclusivity 

statutory and regulatory provisions as 

they apply to certain fixed-combination 

drug products (fixed combinations). As 

described in the guidance, a drug 

product will be eligible for 5-year NCE 

exclusivity if it contains a drug 

substance that meets the definition of 

‘‘new chemical entity,’’ regardless of 

whether that drug substance is approved 

in a single-ingredient drug product or in 

certain fixed-combinations. This 

guidance finalizes the draft guidance 

issued in February 2014. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Bldg., 4th 

Floor, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance 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: 

Nisha Shah, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6222, Silver Spring, 

MD 20993–0002, 301–796–4455; or Jay 

Sitlani, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6272, Silver Spring, 

MD 20993–0002, 301–796–5202. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘New 

Chemical Entity Exclusivity 

Determinations for Certain FixedCombination Drug Products.’’ This 

guidance sets forth a change in the 

Agency’s interpretation of the 5-year 

NCE exclusivity provisions as they 

apply to certain fixed-combinations. 

Section 505(c)(3)(E)(ii) and (j)(5)(F)(ii) of 

the Food, Drug, and Cosmetic Act and 

21 CFR 314.108, among other 

provisions, establish the scheme under 

which a drug product is eligible for 5- 

year NCE exclusivity. The Agency 

historically interpreted the term ‘‘drug’’ 

as it appears in the first sub-clause of 

the statutory provisions and in the 

definition of ‘‘new chemical entity’’ in 

its regulation to mean ‘‘drug product.’’ 

This resulted in a fixed-combination not 

being eligible for 5-year NCE exclusivity 

if it contained any drug substance that 

contained an active moiety that had 

been previously approved by the 

Agency, even if the fixed-combination 

also contained another drug substance 

that contained a previously unapproved 

active moiety. 

The Agency recognizes, however, that 

fixed-combinations have become 

increasingly prevalent in certain 

therapeutic areas and that these 

products play an important role in 

optimizing adherence to dosing 

regimens and improving patient 

outcomes. Therefore, to further 

incentivize the development of fixedcombinations containing previously 

unapproved active moieties, the 

guidance sets forth the Agency’s revised 

interpretation regarding the eligibility 

for 5-year NCE exclusivity of certain 

fixed-combinations. Under the revised 

interpretation, the term ‘‘drug’’ in the 

relevant provisions is interpreted to 

mean ‘‘drug substance’’ or ‘‘active 

ingredient,’’ and not ‘‘drug product.’’ 

Accordingly, a drug product is eligible 

for 5-year NCE exclusivity provided that 

it contains a drug substance that 

contains no active moiety that has been 

previously approved. This will permit a 

drug substance that meets the definition 

of new chemical entity (i.e., one that 

contains no previously approved active 

moiety) to be eligible for 5-year NCE 

exclusivity, regardless of whether it is 

approved in a single-ingredient drug 

product, in a fixed-combination with 

another drug substance that contains no 

other previously approved active 

moiety, or in a fixed-combination with 

another drug substance that contains a 

previously approved active moiety. 

In the Federal Register of February 

24, 2014 (79 FR 10167), this guidance 

was published as a draft guidance. We 

have carefully reviewed and considered 

the comments that were received on the 

draft guidance. We have made editorial 

changes primarily for clarification. 

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 5-year NCE 

exclusivity for certain fixedcombinations. 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 either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

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, and 

will be posted to the docket at http://

www.regulations.gov. 

III. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 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 of 

information in 21 CFR parts 314 have 

been approved under OMB control 

number 0910–0001. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
62164 Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 

Dated: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24597 Filed 10–15–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Public Conference—Vitamin D: Moving 

Toward Evidence-Based Decision 

Making for Primary Care 

SUMMARY: A conference to identify 

issues surrounding evidence-based 

decision making for vitamin D in 

primary care will be held December 2– 

3, 2014, on the main campus of the 

National Institutes of Health (NIH) in 

Bethesda, Maryland. It will also be 

broadcast as a webinar. The conference 

discussions will serve to highlight 

research gaps as well as data and 

methodological needs relevant to 

reducing uncertainties surrounding 

vitamin D in primary care practice. All 

persons are invited to attend, especially 

clinical educators, those who develop 

clinical recommendations, health care 

providers and researchers. Persons 

wishing to attend are required to register 

in advance of the conference. 

DATES: December 2–3, 2014; 8:00 to 5:00 

p.m. (Eastern Time) on first day and 

8:00 to noon on second day. 

ADDRESSES: National Institutes of 

Health, William H. Natcher Building; 

Natcher Conference Center, Building 45. 

Bethesda, Maryland, 20892. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Cindy Rooney, Office of Dietary 

Supplements, National Institutes of 

Health, 6100 Executive Boulevard, 

Room 3B01, Bethesda, MD 20892–7523, 

Email: rooneyc@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

conference is sponsored by the NIH 

Office of Dietary Supplements along 

with co-sponsors from 10 federal 

agencies. Information about the 

conference agenda, registration 

procedures, and webinar arrangements 

can be found at: https://eventssupport.com/events/Vitamin_D_

Primary_Care. 

Through its Vitamin D Initiative, the 

National Institutes of Health (NIH) 

Office of Dietary Supplements (ODS) 

leads several efforts to advance 

scientific understanding of vitamin D 

and health: http://ods.od.nih.gov/

Research/VitaminD.aspx. 

Dated: October 8, 2014. 

Lawrence A. Tabak, 

Principal Deputy Director, NIH. 

[FR Doc. 2014–24455 Filed 10–15–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Nephrology. 

Date: October 27, 2014. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Mushtaq A Khan, DVM, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2176, 

MSC 7818, Bethesda, MD 20892, 301–435– 

1778, khanm@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Pain. 

Date: November 4–5, 2014. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: John Bishop, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5182, 

MSC 7844, Bethesda, MD 20892, (301) 408– 

9664, bishopj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business PAR Panel: Safe and Effective 

Instruments and Devices for Use in Neonatal 

and Pediatric Care Settings. 

Date: November 6, 2014. 

Time: 11:00 a.m. to 5:00 p.m.. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: John Firrell, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5118, 

MSC 7854, Bethesda, MD 20892, 301–435– 

2598, firrellj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Fellowship: 

Surgical Sciences, Biomedical Imaging and 

Bioengineering. 

Date: November 7, 2014. 

Time: 10:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

Contact Person: Weihua Luo, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5114, 

MSC 7854, Bethesda, MD 20892, 301–435– 

1170, luow@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Respiratory Sciences. 

Date: November 13–14, 2014. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Yuanna Cheng, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4138, 

MSC 7814, Bethesda, MD 20892, (301) 435– 

1195, Chengy5@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Molecular and Therapeutic 

Genetics. 

Date: November 13, 2014. 

Time: 3:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Ronald Adkins, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2206, 

MSC 7890, Bethesda, MD 20892, 301–435– 

4511, ronald.adkins@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Digestive Sciences. 

Date: November 14, 2014. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion,4300 Military Road NW., 

Washington, DC 20015. 

Contact Person: Martha Garcia, Ph.D., 

Scientific Reviewer Officer, Center for 

Scientific Review, National Institutes of 


asabaliauskas on DSK5VPTVN1PROD with NOTICES