7586 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices 

guidance practices regulation (21 CFR 

10.115). The draft guidances, when 

finalized, will represent the Agency’s 

current thinking on the design of BE 

studies to support ANDAs for rifaximin200 and rifaximin-550. They do not 

create or confer any rights for or on any 

person and do 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 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the documents at either 

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

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http:// 

www.regulations.gov. 

Dated: February 7, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3234 Filed 2–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Draft Guidance for Industry on 

Bioequivalence Recommendation for 

Nitroglycerin Metered Spray/ 

Sublingual Products and Metered 

Aerosol/Sublingual Products; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of two draft guidances for 

industry entitled ‘‘Bioequivalence 

Recommendations for Nitroglycerin,’’ 

one for nitroglycerin metered spray/ 

sublingual products and one for 

nitroglycerin metered aerosol/ 

sublingual products. The 

recommendations provide specific 

guidance on the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) for these products. The draft 

guidances are revised versions of 

previously published draft guidances on 

the subject. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on the draft 

guidances before it begins work on the 

final versions of the guidances, submit 

either electronic or written comments 

on the draft guidances by April 13, 

2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidances to 

the Division of Drug Information, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

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 draft guidance documents. 

Submit electronic comments on the 

draft guidances 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: 

Doan T. Nguyen, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 7519 

Standish Pl., Rockville, MD 20855, 240– 

276–8608. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register sof June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry, 

‘‘Bioequivalence Recommendations for 

Specific Products,’’ which explained the 

process that would be used to make 

product-specific BE recommendations 

available to the public on FDA’s Web 

site at http://www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. As 

described in that guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific BE recommendations and 

provide a meaningful opportunity for 

the public to consider and comment on 

those recommendations. This document 

announces the availability of two 

revised draft BE recommendations, one 

for nitroglycerin metered spray/ 

sublingual products and one for 

nitroglycerin metered aerosol/ 

sublingual products. 

Nitrolingual Pumpspray (nitroglycerin 

lingual spray), approved by FDA in 

October 1985, is a metered dose spray 

indicated for acute relief of an attack or 

prophylaxis of angina pectoris due to 

coronary artery disease. Nitromist 

(nitroglycerin lingual aerosol), approved 

by FDA in November 2006, is another 

metered dose spray indicated for acute 

relief of an attack or acute prophylaxis 

of angina pectoris due to coronary artery 

disease. Nitrolingual Pumpspray and 

Nitromist are designated as reference 

listed drugs (RLDs), and therefore any 

ANDAs for generic nitroglycerin lingual 

spray or generic nitroglycerin lingual 

aerosol must demonstrate BE to the 

relevant RLD prior to approval. There 

are no approved ANDAs for these 

products. 

In February 2010, FDA posted on its 

Web site a draft guidance for industry 

on the Agency’s recommendations for 

BE studies to support ANDAs for 

nitroglycerin metered spray/sublingual 

products (Draft Nitroglycerin Spray BE 

Recommendations of February 2010). In 

that draft guidance, FDA recommended 

three studies to demonstrate BE of 

generic nitroglycerin metered spray/ 

sublingual products: An in vivo fasting 

study, an in vitro study of unit dose and 

uniformity of unit dose, and an in vitro 

study of priming and tail off. 

In March 2010, FDA posted on its 

Web site a draft guidance for industry 

on the Agency’s recommendations for 

BE studies to support ANDAs for 

nitroglycerin metered aerosol/ 

sublingual products (Draft Nitroglycerin 

Aerosol BE Recommendations of March 

2010). In that draft guidance, FDA 

recommended three studies to 

demonstrate BE of generic nitroglycerin 

metered aerosol/sublingual products: 

An in vivo fasting study, an in vitro 

study of unit dose and uniformity of 

unit dose, and an in vitro study of 

priming and tail off. 

FDA has reconsidered the 

recommendations for both of these draft 

guidances and has decided to revise 

them. In November 2011, FDA 

withdrew the Draft Nitroglycerin Spray 

BE Recommendations of February 2010 

and the Draft Nitroglycerin Aerosol BE 

Recommendations of March 2010. FDA 

is now issuing revised draft guidances 

for industry on BE recommendations for 

nitroglycerin metered spray/sublingual 

products (Revised Draft Nitroglycerin 

Spray BE Recommendations) and 

nitroglycerin metered aerosol/ 

sublingual products (Revised Draft 

Nitroglycerin Aerosol BE 

Recommendations). In these revised 

draft guidances, FDA recommends one 


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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices 7587 

study (an in vivo fasting study) to 

demonstrate BE of generic nitroglycerin 

metered spray/sublingual products and 

generic nitroglycerin metered aerosol/ 

sublingual products. In both of the 

revised draft guidances, FDA notes that 

even though we have not requested 

comparative in vitro studies, in vitro 

studies outlined in the 2002 guidance 

for industry, ‘‘Nasal Spray and 

Inhalation Solution, Suspension, and 

Spray Drug Products—Chemistry, 

Manufacturing, and Controls 

Documentation,’’ should still be 

submitted for chemistry, manufacturing, 

and controls evaluation. 

In December 2010, G. Pohl-Boskamp 

GmbH and Company KG (Pohl), 

manufacturer of the RLD Nitrolingual 

Pumpspray, filed a citizen petition 

challenging FDA’s Draft Nitroglycerin 

Spray BE Recommendations of February 

2010 (Docket No. FDA–2010–P–0648). 

FDA is reviewing the issues raised in 

the petition and will consider any 

comments on the Revised Draft 

Nitroglycerin Spray BE 

Recommendations before responding to 

Pohl’s citizen petition and finalizing its 

BE recommendation for nitroglycerin 

metered spray/sublingual products. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidances, when 

finalized, will represent the Agency’s 

current thinking on the design of BE 

studies to support ANDAs for 

nitroglycerin metered spray/sublingual 

products and nitroglycerin metered 

aerosol/sublingual products. They do 

not create or confer any rights for or on 

any person and do 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 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. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the documents at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: February 7, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3233 Filed 2–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Gastrointestinal 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Gastrointestinal 

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 March 13, 2012, from 8 a.m. to 

5 p.m. 

Location: Hilton Washington, DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

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, email: GIDAC@fda.hhs.gov, 

FAX: 301–847–8533, 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 

and provide general advice on the 

appropriate target populations, 

objectives and designs of trials intended 

to evaluate products for the control of 

hyperbilirubinemia (increased levels of 

bilirubin in the body) in newborn 

infants. 

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: On March 13, 2012, from 

8 a.m. to 12:30 p.m., the meeting is open 

to the public. 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 February 28, 2012. 

Oral presentations from the public will 

be scheduled between approximately 11 

a.m. and 12 noon. 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 February 

17, 2012. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 21, 2012. 

Closed Presentation of Data: On 

March 13, 2012, from 1:15 p.m. to 5 

p.m., the meeting will be closed to 

permit discussion and review of trade 

secret and/or confidential commercial 

information (5 U.S.C. 552b(c)(4)). 

During this session, the committee will 

discuss the drug development program 

of an investigational drug. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Nicole 


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