Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 46021 

written or electronic comments on the 

draft guidance by October 6, 2008. 

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single copies of the draft guidance to the 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, 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. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Larry Ouderkirk, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4125, 

Silver Spring, MD 20993, 301–796–

1585. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Residual Solvents in Drug Products 

Marketed in the United States.’’

Beginning July 1, 2008, FDA will 

require that drug products marketed in 

the United States with an official USP 

monograph meet the residual solvents 

requirements in the revised General 

Chapter <467> ‘‘Residual Solvents.’’

For compendial drug products 

approved under a new drug application 

(NDA) or abbreviated new drug 

application (ANDA), changes made to 

the specifications in the approved 

application regarding the revised 

General Chapter <467> should be in 

accordance with applicable regulations 

described in 21 CFR 314.70 and the 

recommendations in the guidance for 

industry on ‘‘Changes to an Approved 

NDA or ANDA, April 2004.’’ FDA 

expects that in most cases, an annual 

report can be used to report changes. 

FDA recommends that applicants who 

have submitted NDAs or ANDAs to the 

agency for drug products that are not the 

subject of an official USP monograph 

control and limit the presence of 

residual solvents in the subject drug 

product as described in the guidance on 

‘‘Q3C Impurities: Residual Solvents.’’

Marketed compendial drug products 

that are not approved under an NDA or 

ANDA (for example, over-the-counter 

(OTC) drug products that are marketed 

under an FDA OTC monograph) are also 

subject to the provisions of the Federal 

Food, Drug, and Cosmetic Act, the 

revised General Chapter <467>, and 

current good manufacturing practice 

requirements in 21 CFR 211.165(e) and 

211.194(a)(2). 

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 control of residual solvents in drug 

products marketed in the United States. 

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) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: July 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–18127 Filed 8–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Advisory Committee for Reproductive 

Health Drugs; 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: Advisory 

Committee for Reproductive Health 

Drugs. 

General Function of the Committee: 

To provide advice and 

recommendations to theagency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on September 8, 2008, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Rockville, Plaza Ballrooms I and II, 1750 

Rockville Pike, Rockville, MD. The hotel 

phone number is 301–468–1100. 

Contact Person: Kalyani Bhatt, Center 

for Drug Evaluation and Research (HFD–

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–7001, FAX: 301–

827–6776, e-mail: 

kalyani.bhatt@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 301–451–

2537. 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 

new drug application (NDA) 22–242, 

proposed trade name FABLYN 

(lasofoxifene tartrate) Tablets, 0.5 

milligrams (mg), Pfizer Inc., for the 

proposed indication of the treatment of 

osteoporosis in postmenopausal women 

at increased risk of fracture. 

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 


sroberts on PROD1PC70 with NOTICES
46022 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 

1FDA has verified the Web site address, but FDA 

is not responsible for any subsequent changes to the 

Web site after this document publishes in the 

Federal Register. 

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/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2008 and scroll down to the 

appropriate advisory committee 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 August 27, 2008. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

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 August 19, 2008. 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 August 20, 2008. 

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 Kalyani 

Bhatt (301) 827–7001 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/oc/advisory/ 

default.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: July 29, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–18131 Filed 8–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0416] 

Consideration of FDA-Regulated 

Products That May Contain Nanoscale 

Materials; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting and a request for 

comments including available data to 

gather information that will assist the 

agency in further implementing the 

recommendations of the 

Nanotechnology Task Force Report (the 

Report) relating to the development of 

agency guidances. The Report’s 

recommendations covered foods 

(including dietary supplements), food 

and color additives (including food 

contact substances), animal drugs and 

feeds, cosmetics, human drugs and 

biologics, and medical devices. In 

addition to requesting comments in 

response to the questions in this notice 

and those that will be discussed at the 

public meeting, FDA is announcing a 

request for available data and 

information on the effects of nanoscale 

materials on quality, safety, and, where 

relevant, effectiveness of products 

subject to FDA oversight. 

DATES: The public meeting will be held 

on September 8, 2008, from 8:30 a.m. to 

5 p.m. Anyone who wishes to speak at 

the meeting must register and submit a 

summary of the presentation and an 

electronic copy of the presentation by 

Tuesday, September 2, 2008. See section 

IV of the SUPPLEMENTARY INFORMATION

section of this document for details on 

how to register. Submit written or 

electronic comments by Friday, October 

24, 2008. 

ADDRESSES: The public meeting will be 

held at the University Systems of 

Maryland Shady Grove Center/ 

Universities, 9630 Gudelsky Dr., 

Rockville, MD 20850 (http:// 

www.shadygrove.umd.edu/conference).1

There is parking near the building. 

Submit written comments, available 

data, and other information to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Megan Clark, Office of Policy, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

3360, e-mail: megan.clark@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Nanotechnology allows scientists to 

work on the scale of molecules to create, 

explore, and manipulate materials 

measured in nanometers; billionths of a 

meter. In July 2007, FDA issued the 

Report analyzing scientific and 

regulatory considerations relating to the 

safety and effectiveness of FDAregulated products containing nanoscale 

materials regulated by FDA, and making 

recommendations regarding these 

considerations. Additionally, the Report 

summarized the state of the science for 

biological interactions with nanoscale 

materials. The Report also 

recommended that FDA coordinate with 

other Federal agencies and the private 

sector in research and other activities to 

increase general scientific 

understanding and facilitate assessment 

of data needs for regulated products. 

This coordination includes developing 

an infrastructure to share and leverage 

knowledge and build upon information 

from individual studies of nanoscale 

materials. 

The agency has been considering 

development of guidances 

recommended in the Report and 

believes that holding a public meeting 

and announcing this request for 

comments and available data will 

provide information that will assist in 

this task. In addition, FDA is working 

with the National Institutes of Health 

(particularly the NanoHealth Enterprise) 

to explore methods for receiving and 

sharing data relating to, for example, 

general product development, including 

research on failed product candidates, 

and biological interactions of certain 

characteristics of nanoscale materials. 

Such a data repository could allow FDA 

and other stakeholders to share data and 

methods, and to develop models of 

biological interaction that could then 

inform product development and 

review. 

II. Meeting Agenda 

The primary purpose of the meeting is 

to determine what factors the agency 

should consider in providing guidance 

on: 

1. The information and data that may 

be needed to demonstrate the safety and 

effectiveness of FDA-regulated products 

containing nanoscale materials and 


sroberts on PROD1PC70 with NOTICES