924 Federal Register / Vol. 69, No. 4 / Wednesday, January 7, 2004 / Notices 

docket number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of 

Management Programs (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659.

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document.

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology.

Generic FDA Rapid Response Surveys 

(OMB Control Number 0910–0500)—

Extension

Section 505 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355), requires that important safety 

information relating to all human 

prescription drug products be made 

available to FDA so that it can take 

appropriate action to protect the public 

health when necessary. Section 702 of 

the act (21 U.S.C. 372) authorizes 

investigational powers to FDA for 

enforcement of the act. Under section 

519 of the act (21 U.S.C. 360i), FDA is 

authorized to require manufacturers to 

report medical device-related deaths, 

serious injuries, and malfunctions to 

FDA, and to require user facilities to 

report device-related deaths directly to 

FDA and to manufacturers, and to report 

serious injuries to the manufacturer. 

Section 522 of the act (21 U.S.C. 360l) 

authorizes FDA to require 

manufacturers to conduct postmarket 

surveillance of medical devices. Section 

705(b) of the act (21 U.S.C. 375(b)) 

authorizes FDA to collect and 

disseminate information regarding 

medical products or cosmetics in 

situations involving imminent danger to 

health or gross deception of the 

consumer. Section 903(d)(2) of the act 

(21 U.S.C. 393(d)(2)) authorizes the 

Commissioner of Food and Drugs to 

implement general powers (including 

conducting research) to carry out 

effectively the mission of FDA. These 

sections of the act enable FDA to 

enhance consumer protection from risks 

associated with medical products usage 

that are not foreseen or apparent during 

the premarket notification and review 

process. FDA’s regulations governing 

application for agency approval to 

market a new drug (21 CFR part 314) 

and regulations governing biological 

products (21 CFR part 600) implement 

these statutory provisions. Currently 

FDA monitors medical product related 

postmarket adverse events via both the 

mandatory and voluntary MedWatch 

reporting systems using FDA Forms 

3500 and 3500A (OMB control number 

0910–0291) and the vaccine adverse 

event reporting system. FDA is seeking 

OMB clearance to collect vital 

information via a series of rapid 

response surveys. Participation in these 

surveys will be voluntary. This request 

covers rapid response surveys for 

community based health care 

professionals, general type medical 

facilities, specialized medical facilities 

(those known for cardiac surgery, 

obstetrics/gynecology services, pediatric 

services, etc.), other health care 

professionals, patients, consumers, and 

risk managers working in medical 

facilities. FDA will use the information 

gathered from these surveys to obtain 

quickly vital information about medical 

product risks and interventions to 

reduce risks so the agency may take 

appropriate public health or regulatory 

action including dissemination of this 

information as necessary and 

appropriate.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Response Total Hours 

200 30 (maximum) 6,000 0.5 3,000

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

FDA projects 30 emergency riskrelated surveys per year with a sample 

of between 50 and 200 respondents per 

survey. FDA also projects a response 

time of 0.5 hours per response. These 

estimates are based on the maximum 

sample size per questionnaire that FDA 

can analyze in a timely manner. The 

annual frequency of response was 

determined by the maximum number of 

questionnaires that will be sent to any 

individual respondent. Some 

respondents may be contacted only 1 

time per year, while other respondents 

may be contacted several times 

annually, depending on the human 

drug, biologic, or medical device under 

evaluation. It is estimated that, given the 

expected type of issues that will be 

addressed by the surveys, it will take 0.5 

hours for a respondent to gather the 

requested information and fill in the 

answers.

Dated: December 30, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–258 Filed 1–6–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[FDA 225–04–4001]

Memorandum of Understanding 

Between the Food and Drug 

Administration and Customs and 

Border Protection, Department of 

Homeland Security

AGENCY: Food and Drug Administration, 

HHS.

Federal Register / Vol. 69, No. 4 / Wednesday, January 7, 2004 / Notices 925

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between the Food 

and Drug Administration and Customs 

and Border Protection (CBP), 

Department of Homeland Security to 

allow FDA to commission CBP officers.

DATES: The agreement became effective 

December 3, 2003.

FOR FURTHER INFORMATION CONTACT:

Deborah Ralston, Office of Regional 

Operations (HFC–100), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–443–6230.

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU.

Dated: December 29, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

BILLING CODE 4160–01–S

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[FR Doc. 04–260 Filed 1–6–04; 8:45 am]

BILLING CODE 4160–01–C

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0571]

Draft Guidance for Industry on Drug 

Substance; Chemistry, Manufacturing, 

and Controls Information; Availability

AGENCY: Food and Drug Administration.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Drug Substance: 

Chemistry, Manufacturing, and Controls 

Information.’’ This draft guidance 

provides recommendations on the 

chemistry, manufacturing, and controls 

(CMC) information for drug substances 

that should be submitted to support 

original new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), new animal drug applications 

(NADAs), and abbreviated new animal 

drug applications (ANADAs). The draft 

guidance is structured to facilitate the 

preparation of applications submitted in 

Common Technical Document (CTD) 

format.

DATES: Submit written or electronic 

comments on the draft guidance by July 

5, 2004. 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, or to the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. 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.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Steve Miller, Center for Drug 

Evaluation and Research (HFD–

530), Food and Drug 

Administration, 9201 Corporate 

Blvd., Rockville, MD 20850, 301–

827–2392, or

Chris Joneckis, Center for Biologics 

Evaluation and Research (HFM–1), 

Food and Drug Administration, 

8800 Rockville Pike, Bethesda, MD 

20892, 301–435–5681, or

Dennis Bensley, Center for Veterinary 

Medicine (HFV–143), Food and 

Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 301–827–

6956

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Drug Substance: Chemistry, 

Manufacturing, and Controls 

Information.’’ This draft guidance 

provides recommendations on the drug 

substance information to be submitted 

in NDAs, ANDAs, NADAs, and 

ANADAs to ensure continued drug 

substance and drug product quality (i.e., 

the identity, strength, quality, purity, 

and potency). Recommendations are 

provided on the information that should 

be included for: (1) Nomenclature, 

structure, and general drug substance 

properties, (2) manufacture, (3) 

characterization, (4) control of drug 

substance, (5) reference standards or 

materials, (6) container closure system, 

and (7) stability. The draft guidance is 

structured to facilitate the preparation of 

applications submitted in CTD format. 

The draft guidance, when finalized, will 

replace the guidance entitled 

‘‘Submitting Supporting Documentation 

in Drug Applications for the 

Manufacture of Drug Substance’’

(February 1987).

This 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 guidance was approved under OMB 

control numbers 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 


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