Federal Register / Vol. 70, No. 19 / Monday, January 31, 2005 / Notices 4853

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

A Library Of Participant Questions To 

Be Used In Exposure Investigation 

Questionnaires—New—The Agency for 

Toxic Substances and Disease Registry 

(ATSDR). 

ATSDR is mandated pursuant to the 

1980 Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) and its 1986 

Amendments, the Superfund 

Amendments and Reauthorization Act 

(SARA) to prevent or mitigate adverse 

human health effects and diminished 

quality of life resulting from the 

exposure to hazardous substances in the 

environment. Exposure Investigations 

are an approach developed by ATSDR 

that employs targeted biologic and 

environmental sampling to assist 

ATSDR to better characterize past, 

current, and possible future human 

exposures to hazardous substances in 

the environment. The purpose of 

Exposure Investigations is to determine 

in a timely manner whether community 

residents are being exposed to chemical 

contaminants at levels that might affect 

their health. Exposure Investigations are 

usually requested by officials of a state 

health agency, county health 

departments, the Environmental 

Protection Agency, the general public, 

and ATSDR staff. 

During an Exposure Investigation 

ATSDR conducts biomarker testing or 

environmental testing or both. 

Biomarkers may be sampled in urine, 

blood, or hair. Environmental samples 

(e.g., air, water, soil, or food) can be 

taken from the environment where 

people live, spend leisure time, or other 

places they might come into contact 

with contaminants under investigation. 

In addition to the suspected 

environmental exposure source being 

investigated, additional exposure to the 

contaminant may come from other 

sources encountered in daily activities 

such as jobs, hobbies, household 

products, lifestyle, medicines, and 

foods. 

To assist in interpreting the sampling 

results, a survey questionnaire 

appropriate to the specific contaminant 

will be administered to participants. 

Only a limited number of questions 

pertinent to exposure routes of the 

contaminant of concern will be 

administered in an investigation. 

Questions will be asked about the 

presence or absence of a specific 

exposure and an estimate of its extent 

and duration. Exposure to other sources 

of the contaminant of concern will also 

be queried in the survey. The 

information gathered in the survey will 

allow ATSDR to more accurately 

interpret its testing results and 

determine a likely source of elevated 

biomarker tests. 

Questionnaires will generally be 

administered face-to-face and 

occasionally by phone or mail. 

Typically, ATSDR conducts between 

10–15 exposure investigations 

nationally each year that would require 

a questionnaire. The number of 

participants per investigation ranges 

from 10 to less than 50. 

ATSDR is seeking approval for a set 

of 40–43 potential questions. Of these, 

approximately 12–15 questions about 

the pertinent environmental pathways 

in an Exposure Investigation will be 

used. This number can vary depending 

on the number of contaminants being 

investigated, the route of exposure 

(breathing, eating, touching), and a 

number of other sources (e.g., products, 

jobs) of the chemical(s). We will also 

collect general information (e.g., name, 

address,) necessary to conduct the 

investigation; there are approximately 

28 questions that will collect 

demographic information. There are no 

costs to respondents other than their 

time. 

Topic areas for the complete set of 

questions include the following: 

(1) Media specific which includes: air 

(indoor/outdoor); water (water source 

and plumbing); soil, and food 

(gardening, fish, game, domestic 

animals). 

(2) Other sources such as: occupation; 

hobbies; household uses or house 

construction; lifestyle (e.g., smoking); 

medicines and/or health conditions, and 

foods.

Respondents Number of

respondents 

Number of

responses

per respondent 

Average

burden

per response

in hours) 

Total

burden

(in hours) 

Exposure Investigation Participants ................................................................ 750 1 30/60 375 

Total .......................................................................................................... ........................ ........................ ........................ 375 

Dated: January 25, 2005. 

Betsey Dunaway, 

Acting Reports Clearance Officer, Office of 

the Chief Science Officer, Centers for Disease 

Control and Prevention.

[FR Doc. 05–1713 Filed 1–28–05; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0441]

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Application for 

Food and Drug Administration 

Approval to Market a New Drug

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the 

collection of information by March 2, 

2005.

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: Fumie Yokota, Desk Officer 

for FDA, FAX: 202–395–6974.

4854 Federal Register / Vol. 70, No. 19 / Monday, January 31, 2005 / Notices 

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance.

Application for FDA Approval to 

Market a New Drug—(OMB Control 

Number 0910–0001)—Extension

Under section 505(a) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 355(a)), a new drug may not 

be commercially marketed in the United 

States, imported, or exported from the 

United States, unless an approval of an 

application filed with FDA under 

section 505(b) or 505(j) of the act is 

effective with respect to such drug. 

Section 505(b) and 505(j) of the act 

requires a sponsor to submit to FDA a 

new drug application (NDA) containing, 

among other things, full reports of 

investigations that show whether or not 

the drug is safe and effective for use, a 

full list of articles used as components 

in the drug, a full description of 

manufacturing methods, samples of the 

drugs required, specimens of the 

labeling proposed to be used, and 

certain patent information as applicable. 

Under the act, it is the sponsor’s 

responsibility to provide the 

information needed by FDA to make a 

scientific and technical determination 

that the product is safe and effective.

This information collection approval 

request is for all information 

requirements imposed on sponsors by 

the regulations under part 314 (21 CFR 

314), who apply for approval of a new 

drug application in order to market or 

to continue to market a drug.

Section 314.50(a) requires that an 

application form (Form FDA 356h) be 

submitted that includes introductory 

information about the drug as well as a 

checklist of enclosures.

Section 314.50(b) requires that an 

index be submitted with the archival 

copy of the application and that it 

reference certain sections of the 

application.

Section 314.50(c) requires that a 

summary of the application be 

submitted that presents a good general 

synopsis of all the technical sections 

and other information in the 

application.

Section 314.50(d) requires that the 

NDA contain the following technical 

sections about the new drug: Chemistry, 

manufacturing, and controls; 

nonclinical pharmacology and 

toxicology; human pharmacokinetics 

and bioavailability; microbiology; 

clinical data; and statistical section.

Section 314.50(e) requires the 

applicant to submit samples of the drug 

if requested by FDA. In addition, the 

archival copy of the application must 

include copies of the label and all 

labeling for the drug.

Section 314.50(f) requires that case 

report forms and tabulations be 

submitted with the archival copy.

Section 314.50(h) requires that patent 

information, as described under 

§ 314.53, be submitted with the 

application.

Section 314.50(i) requires that patent 

certification information be submitted 

in section 505(b)(2) applications for 

patents claiming the drug, drug product, 

method of use, or method of 

manufacturing.

Section 314.50(j) requires that 

applicants that request a period of 

marketing exclusivity submit certain 

information with the application.

Section 314.50(k) requires that an 

archival, review, and field copy of the 

application be submitted.

Section 314.52 requires that notice of 

certification of invalidity or 

noninfringement of a patent to patent 

holders and NDA holders be sent by 

section 505(b)(2) applicants.

Section 314.54 sets forth the content 

requirements for applications filed 

under section 505(b)(2) of the act.

Section 314.60 sets forth reporting 

requirements for sponsors who amend 

an unapproved application.

Section 314.65 states that the sponsor 

must notify FDA when withdrawing an 

unapproved application.

Sections 314.70 and 314.71 require 

that supplements be submitted to FDA 

for certain changes to an approved 

application.

Section 314.72 requires sponsors to 

report to FDA any transfer of ownership 

of an application.

Section 314.80(c)(1) and (c)(2) sets 

forth requirements for expedited 

adverse drug experience postmarketing 

reports and followup reports, as well as 

for periodic adverse drug experience 

postmarketing reports (Form FDA 

3500A). (The burden hours for 

§ 314.80(c)(1) and (c)(2) are already 

approved by OMB under OMB control 

numbers 0910–0230 and 0910–0291 and 

are not included in the hour burden 

estimates in table 1 of this document.)

Section 314.80(i) establishes 

recordkeeping requirements for reports 

of postmarketing adverse drug 

experiences. (The burden hours for 

§ 314.80(i) are already approved by 

OMB under OMB control numbers 

0910–0230 and 0910–0291 and are not 

included in the hour burden estimates 

in table 1 of this document.)

Section 314.81(b)(1) requires that field 

alert reports be submitted to FDA (Form 

FDA 3331).

Section 314.81(b)(2) requires that 

annual reports be submitted to FDA 

(Form FDA 2252). This form has been 

revised as a result of the requirements 

in the final rule ‘‘Postmarketing Studies 

for Approved Human Drug and 

Licensed Biological Products; Status 

Reports,’’ published in the Federal 

Register of October 30, 2000 (65 FR 

64607). The rule describes the types of 

postmarketing studies covered by the 

status reports, the information to be 

included in the reports, and the type of 

information that FDA would consider 

appropriate for public disclosure. The 

rule implemented section 130(a) of the 

Food and Drug Administration 

Modernization Act of 1997 (FDAMA). 

The changes to the form include adding 

new spaces for the new status reports, 

reporting for biological products, and 

editorial changes.

Section 314.81(b)(3)(i) requires that 

drug advertisements and promotional 

labeling be submitted to FDA (Form 

FDA 2253).

Section 314.81(b)(3)(iii) sets forth 

reporting requirements for sponsors 

who withdraw an approved drug 

product from sale. (The burden hours 

for § 314.81(b)(3)(iii) are already 

approved by OMB under OMB control 

number 0910–0045 and are not included 

in the hour burden estimates in table 1 

of this document.)

Section 314.90 sets forth requirements 

for sponsors who request waivers from 

FDA for compliance with §§ 314.50 

through 314.81. (The information 

collection hour burden estimate for 

NDA waiver requests is included in 

table 1 of this document under estimates 

for §§ 314.50, 314.60, 314.70 and 

314.71.)

Section 314.93 sets forth requirements 

for submitting a suitability petition in 

accordance with § 10.20 (21 CFR 10.20) 

and § 10.30. (The burden hours for 

§ 314.93 are already approved by OMB 

under 0910–0183 and are not included 

in the hour burden estimates in table 1 

of this document.)

Section 314.94(a) and (d) requires that 

an ANDA contain the following 

information: Application form; table of 

contents; basis for ANDA submission; 

conditions of use; active ingredients; 

route of administration, dosage form, 

and strength; bioequivalence; labeling; 

chemistry, manufacturing, and controls; 

samples; patent certification.

Section 314.95 requires that notice of 

certification of invalidity or 

noninfringement of a patent to patent 

Federal Register / Vol. 70, No. 19 / Monday, January 31, 2005 / Notices 4855

holders and NDA holders be sent by 

ANDA applicants.

Section 314.96 sets forth requirements 

for amendments to an unapproved 

ANDA.

Section 314.97 sets forth requirements 

for submitting supplements to an 

approved ANDA for changes that 

require FDA approval.

Section 314.98(a) sets forth 

postmarketing adverse drug experience 

reporting and recordkeeping 

requirements for ANDAs. (The burden 

hours for § 314.98(a) are already 

approved by OMB under OMB control 

numbers 0910–0230 and 0910–0291 and 

are not included in the hour burden 

estimates in table 1 of this document.)

Section 314.98(c) requires other 

postmarketing reports for ANDAs: Field 

alert reports (Form FDA 3331), annual 

reports (Form FDA 2252), and 

advertisements and promotional 

labeling (Form FDA 2253). (The 

information collection hour burden 

estimate for field alert reports is 

included in table 1 of this document 

under § 314.81(b)(1); the estimate for 

annual reports is included under 

§ 314.81(b)(2); the estimate for 

advertisements and promotional 

labeling is included under 

§ 314.81(b)(3)(i).)

Section 314.99(a) requires that 

sponsors comply with certain reporting 

requirements for withdrawing an 

unapproved ANDA and for a change in 

ownership of an ANDA.

Section 314.99(b) sets forth 

requirements for sponsors who request 

waivers from FDA for compliance with 

§§ 314.92 through 314.99. (The 

information collection hour burden 

estimate for ANDA waiver requests is 

included in table 1 of this document 

under estimates for § 314.94(a) and (d) 

and §§ 314.96 and 314.97.)

Section 314.101(a) states that if FDA 

refuses to file an application, the 

applicant may request an informal 

conference with FDA and request that 

the application be filed over protest.

Section 314.107(c)(4) requires notice 

to FDA by ANDA or section 505(b)(2) 

application holders of any legal action 

concerning patent infringement.

Section 314.107(e)(2)(iv) requires that 

an applicant submit a copy of the entry 

of the order or judgment to FDA within 

10 working days of a final judgment.

Section 314.107(f) requires that 

ANDA or section 505(b)(2) applicants 

notify FDA of the filing of any legal 

action filed within 45 days of receipt of 

the notice of certification. A patent 

owner may also notify FDA of the filing 

of any legal action for patent 

infringement. The patent owner or 

approved application holder who is an 

exclusive patent licensee must submit to 

FDA a waiver that waives the 

opportunity to file a legal action for 

patent infringement.

Section 314.110(a)(3) and (a)(4) states 

that, after receipt of an FDA approvable 

letter, an applicant may request an 

opportunity for a hearing on the 

question of whether there are grounds 

for denying approval of the application. 

(The burden hours for § 314.110(a)(3) 

and (a)(4) are included under parts 10 

through 16 (21 CFR part 16) hearing 

regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document.)

Section 314.110(a)(5) states that, after 

receipt of an approvable letter, an 

applicant may notify FDA that it agrees 

to an extension of the review period so 

that it can determine whether to 

respond further.

Section 314.110(b) states that, after 

receipt of an approvable letter, an 

ANDA applicant may request an 

opportunity for a hearing on the 

question of whether there are grounds 

for denying approval of the application. 

(The burden hours for § 314.110(b) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document.)

Section 314.120(a)(3) states that, after 

receipt of a not approvable letter, an 

applicant may request an opportunity 

for a hearing on the question of whether 

there are grounds for denying approval 

of the application. (The burden hours 

for § 314.120(a)(3) are included under 

parts 10 through 16 hearing regulations, 

in accordance with § 314.201, and are 

not included in the hour burden 

estimates in table 1 of this document.)

Section 314.120(a)(5) states that, after 

receipt of a not approvable letter, an 

applicant may notify FDA that it agrees 

to an extension of the review period so 

that it can determine whether to 

respond further.

Section 314.122(a) requires that an 

ANDA or a suitability petition that 

relies on a listed drug that has been 

voluntarily withdrawn from sale must 

be accompanied by a petition seeking a 

determination whether the drug was 

withdrawn for safety or effectiveness 

reasons. (The burden hours for 

§ 314.122(a) are already approved by 

OMB under OMB control number 0910–

0183 and are not included in the hour 

burden estimates in table 1 of this 

document.)

Section 314.122(d) sets forth 

requirements for relisting petitions for 

unlisted discontinued products. (The 

burden hours for § 314.122(d) are 

already approved by OMB under OMB 

control number 0910–0183 and are not 

included in the hour burden estimates 

in table 1 of this document.)

Section 314.126(c) sets forth 

requirements for a petition to waive 

criteria for adequate and well-controlled 

studies. (The burden hours for 

§ 314.126(c) are already approved by 

OMB under 0910–0183 and are not 

included in the hour burden estimates 

in table 1 of this document.)

Section 314.151(a) and (b) set forth 

requirements for the withdrawal of 

approval of an ANDA and the 

applicant’s opportunity for a hearing 

and submission of comments. (The 

burden hours for § 314.151(a) and (b) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document.)

Section 314.151(c) sets forth the 

requirements for withdrawal of approval 

of an ANDA and the applicant’s 

opportunity to submit written objections 

and participate in a limited oral hearing. 

(The burden hours for § 314.151(c) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document.)

Section 314.152(b) sets forth the 

requirements for suspension of an 

ANDA when the listed drug is 

voluntarily withdrawn for safety and 

effectiveness reasons, and the 

applicant’s opportunity to present 

comments and participate in a limited 

oral hearing. (The burden hours for 

§ 314.152(b) is included under parts 10 

through 16 hearing regulations, in 

accordance with § 314.201, and is not 

included in the hour burden estimates 

in table 1 of this document.)

Section 314.161(b) and (e) sets forth 

the requirements for submitting a 

petition to determine whether a listed 

drug was voluntarily withdrawn from 

sale for safety or effectiveness reasons. 

(The burden hours for § 314.161(b) and 

(e) are already approved by OMB under 

OMB control number 0910–0183 and 

are not included in the hour burden 

estimates in table 1 of this document.)

Section 314.200(c), (d), and (e) 

requires that applicants or others subject 

to a notice of opportunity for a hearing 

who wish to participate in a hearing file 

a written notice of participation and 

request for a hearing as well as the 

studies, data, and so forth, relied on. 

Other interested persons may also 

submit comments on the notice. This 

section also sets forth the content and 

format requirements for the applicants’

submission in response to notice of 

4856 Federal Register / Vol. 70, No. 19 / Monday, January 31, 2005 / Notices 

opportunity for hearing. (The burden 

hours for § 314.200(c), (d), and (e) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document.)

Section 314.200(f) states that 

participants in a hearing may make a 

motion to the presiding officer for the 

inclusion of certain issues in the 

hearing. (The burden hours for 

§ 314.200(f) are included under parts 10 

through 16 hearing regulations, in 

accordance with § 314.201, and are not 

included in the hour burden estimates 

in table 1 of this document.)

Section 314.200(g) states that a person 

who responds to a proposed order from 

FDA denying a request for a hearing 

provide sufficient data, information, and 

analysis to demonstrate that there is a 

genuine and substantial issue of fact 

which justifies a hearing. (The burden 

hours for § 314.200(g) are included 

under parts 10 through 16 hearing 

regulations, in accordance with 

§ 314.201, and is not included in the 

hour burden estimates in table 1 of this 

document.)

Section 314.420 states that an 

applicant may submit to FDA a drug 

master file in support of an application, 

in accordance with certain content and 

format requirements.

Section 314.430 states that data and 

information in an application are 

disclosable under certain conditions, 

unless the applicant shows that 

extraordinary circumstances exist. (The 

burden hours for § 314.430 is included 

under parts 10 through 16 hearing 

regulations, in accordance with 

§ 314.201, and is not included in the 

hour burden estimates in table 1 of this 

document.)

Section 314.530(c) and (e) states that, 

if FDA withdraws approval of a drug 

approved under the accelerated 

approval procedures, the applicant has 

the opportunity to request a hearing and 

submit data and information. (The 

burden hours for § 314.530(c) and (e) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

hour burden estimates in table 1 of this 

document.)

Section 314.530(f) requires that an 

applicant first submit a petition for stay 

of action before requesting an order 

from a court for a stay of action pending 

review. (The burden hours for 

§ 314.530(f) are already approved by 

OMB under 0910–0194 and are not 

included in the hour burden estimates 

in table 1 of this document.)

In the Federal Register of October 8, 

2004 (69 FR 60402), FDA announced an 

opportunity for public comment on 

these information collection estimates. 

No comments were submitted that 

pertained to the information collection 

estimates in the October 8, 2004, 

document.

Respondents to this collection of 

information are all persons who submit 

an application or abbreviated 

application or an amendment or 

supplement to FDA under part 314 to 

obtain approval of a new drug, and any 

person who owns an approved 

application or abbreviated application.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section; 

[FDA Form Number] No. of Respondents No. of Responses per Respondent 

Total Annual Responses Hours Per Response Total Hours 

314.50 (a), (b), (c), 

(d), (e), (f), (h), 

and (k) 72 1.44 104 1,642 170,768

314.50(i) and 

314.94(a)(12) 194 2.34 454 2 908

314.50(j) 70 3.71 260 2 520

314.52 and 314.95 24 2.25 54 16 864

314.54 16 1 16 300 4,800

314.60 275 19.06 5,242 80 419,320

314.65 10 1 10 2 20

314.70 and 314.71 234 10.99 2,572 150 385,800

314.72 61 4.52 276 2 552

314.81(b)(1) [3331] 115 3.88 447 8 3,576

314.81(b)(2) [2252] 612 12.47 7,632 40 305,280

314.81(b)(3)(i) 

[2253] 332 44.09 14,638 2 29,276

314.94(a) and (d) 100 4.59 459 480 220,320

314.96 275 23.63 6,500 80 520,000

314.97 200 16.75 3,350 80 268,000

314.99(a) 44 2.02 89 2 178

314.101(a) 2 1 2 .50 1

Federal Register / Vol. 70, No. 19 / Monday, January 31, 2005 / Notices 4857

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

21 CFR Section; 

[FDA Form Number] No. of Respondents No. of Responses per Respondent 

Total Annual Responses Hours Per Response Total Hours 

314.107(c)(4), 

314.107(e)(2)(iv), 

and 314.107(f) 3 2 6 1 6

314.110(a)(5) 41 1.26 52 .50 26

314.120(a)(5) 12 1.16 14 .50 7

314.420 403 1.72 694 61 42,334

Total 2,372,556

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: January 25, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–1814 Filed 1–27–05; 12:53 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D–0514]

Draft Guidance for Industry on 

Abbreviated New Drug Applications: 

Impurities in Drug Substances; 

Chemistry, Manufacturing, and 

Controls Information; 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 ‘‘ANDAs: Impurities in 

Drug Substances; Chemistry, 

Manufacturing, and Controls 

Information.’’ This draft guidance 

provides recommendations on what 

chemistry, manufacturing, and controls 

information to include regarding the 

reporting, identification, and 

qualification of impurities in drug 

substances produced by chemical 

synthesis when submitting 

documentation for an abbreviated new 

drug application (ANDA), drug master 

file (DMF), or a supplement to support 

changes in drug substance synthesis or 

process.

DATES: Submit written or electronic 

comments on the draft guidance May 2, 

2005. General comments on agency 

guidance documents are welcome at any 

time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed 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.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Scott Furness, Center for Drug 

Evaluation and Research (HFD–640), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–5849.

SUPPLEMENTARY INFORMATION:

I. Background

On December 3, 1999, FDA published 

in the Federal Register (64 FR 67917) 

the guidance for industry entitled 

‘‘ANDA’s: Impurities in Drug 

Substances.’’ The guidance provided 

recommendations for including 

information in ANDAs and supporting 

DMFs on the content and qualification 

of impurities in drug substances 

produced by chemical syntheses.

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘ANDAs: Impurities in Drug 

Substances,’’ which revises the 

December 3, 1999, guidance. The 

guidance is being revised to update 

information on listing of impurities, 

setting acceptance criteria, and 

qualifying impurities in conformance 

with the revision of the guidance for 

industry entitled ‘‘Q3A Impurities in 

New Drug Substances’’ (Q3A(R), 

published in February 2003). The 

guidance is also being revised to remove 

sections of the guidance containing 

recommendations that are no longer 

needed because they are addressed in 

the more recent Q3A(R).

This draft guidance contains 

information collection provisions 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 this draft guidance was 

approved under OMB Control Nos. 

0910–0001 and 0910–0032.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance represents the 

agency’s current thinking on these 

topics. 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 on the draft guidance. Two 

copies of any comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination 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 http://

www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: January 24, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–1752 Filed 1–28–05; 8:45 am]

BILLING CODE 4160–01–S