Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 77515 

Dated: December 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30108 Filed 12–23–14; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Bioequivalence Recommendations for 

Methylphenidate Hydrochloride 

Extended-Release Oral Suspension; 

Draft Guidance for Industry; 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availability of a draft guidance for 

industry entitled ‘‘Bioequivalence 

Recommendations for Methylphenidate 

Hydrochloride Extended-Release Oral 

Suspension.’’ The recommendations 

provide specific guidance on the design 

of bioequivalence (BE) studies to 

support abbreviated new drug 

applications (ANDAs) for 

methylphenidate hydrochloride (HCl) 

extended-release oral suspension. 

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 comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by February 23, 

2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

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access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http://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: Kris 

Andre ́, Center for Drug Evaluation and 

Research (HFD–600), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4726, Silver Spring, 

MD 20993–0002, 240–402–7959. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of 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 notice 

announces the availability of draft BE 

recommendations for methylphenidate 

HCl extended-release oral suspension. 

New drug application 202100 for 

Quillivant XR (methylphenidate HCl) 

extended-release oral suspension was 

initially approved by FDA in September 

2012. There are no approved ANDAs for 

this product. FDA is now issuing a draft 

guidance for industry on BE 

recommendations for generic 

methylphenidate HCl extended-release 

oral suspension (Draft Methylphenidate 

HCl Oral Suspension BE 

Recommendations). 

In August 2014, Pfizer, Inc., 

manufacturer of the reference listed 

drug, Quillivant XR, submitted a citizen 

petition requesting that FDA establish 

certain BE requirements for any new 

drug product that references Quillivant 

XR and seeks approval by means of 

demonstrating BE to Quillivant XR 

(Docket No. FDA–2014–P–1269). FDA is 

reviewing the issues raised in the 

petition. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the design of BE studies to support 

ANDAs for methylphenidate HCl 

extended-release oral suspension. 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 to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 


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77516 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 

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 document at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: December 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30109 Filed 12–23–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

General and Plastic Surgery Devices 

Panel of the Medical Devices 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: General and 

Plastic Surgery Devices Panel of the 

Medical Devices Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

DATES: Date and Time: The meeting will 

be held on February 27, 2015, from 8 

a.m. to 6 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 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 ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Patricio Garcia, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 1535, Silver Spring MD 20993– 

0002, Patricio.Garcia@fda.hhs.gov, 301– 

796–6875, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area). 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 at http://www.fda.gov/Advisory

Committees/default.htm and scroll 

down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

Agenda: On February 27, 2015, the 

committee will discuss, make 

recommendations and vote on 

information regarding the premarket 

approval application (PMA) panel-track 

supplement to expand the indication for 

use for the Radiesse Injectable Implant 

(Radiesse) device to include subdermal 

implantation for hand augmentation to 

correct volume deficit in the hands. The 

proposed indication for use for the 

Radiesse device, as stated in the PMA is 

as follows: 

The Radiesse device is for hand 

augmentation to correct volume deficit 

in the hands. 

FDA has previously approved the 

Radiesse device for the following two 

indications for use: The Radiesse device 

is indicated for subdermal implantation 

for the correction of moderate to severe 

facial wrinkles and folds, such as 

nasolabial folds. It is also indicated for 

subdermal implantation for restoration 

and/or correction of the signs of facial 

fat loss (lipoatrophy) in people with 

human immunodeficiency virus. The 

Radiesse device remains unchanged 

from the current FDA approved version. 

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 meeting 

link. 

Procedure: 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 3, 2015. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. 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 January 

26, 2015. 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 January 27, 2015. 

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 Annmarie 

Williams at Annmarie.Williams@

fda.hhs.gov, or 301–796–5966 at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: December 17, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–30149 Filed 12–23–14; 8:45 am] 

BILLING CODE 4164–01–P 

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