Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Notices 53021 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: August 22, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–17602 Filed 9–2–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0324] 

International Conference on 

Harmonisation; Draft Guidance on M5 

Data Elements and Standards for Drug 

Dictionaries; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘M5 Data Elements and Standards for 

Drug Dictionaries.’’ The draft guidance 

was prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft guidance describes the data 

elements and standards that ICH 

recommends be made available to 

interested parties to assist in the 

development and maintenance of drug 

dictionaries. The draft guidance is 

intended to facilitate the exchange and 

practical use of medicinal product 

information at the international level, 

such as with postmarketing safety 

reporting. 

DATES: Submit written or electronic 

comments on the draft guidance by 

October 21, 2005. General comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: 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on the draft guidance to the Division of 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. 

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copies of the draft guidance to the 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 the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. The draft 

guidance may also be obtained by mail 

by calling the CBER Voice Information 

System at 1–800–835–4709 or 301–827–

1800. Send two self-addressed adhesive 

labels to assist the office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Randy Levin, 

Center for Drug Evaluation and 

Research (HFD–001), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–

827–7784; or Ann Schwartz, Center 

for Biologics Evaluation and 

Research (HFM–475), Food and 

Drug Administration, 1401 

Rockville Pike, rm. 300N, Rockville, 

MD 20832, 301–827–3070. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of ICH’s 

sponsors and IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In May 2005, the ICH Steering 

Committee agreed that a draft guidance 

entitled ‘‘M5 Data Elements and 

Standards for Drug Dictionaries’’ should 

be made available for public comment. 

The draft guidance is the product of the 

M5 Expert Working Group of the ICH. 

Comments about this draft will be 

considered by FDA and the M5 expert 

working group. 

The draft guidance describes the data 

elements that ICH recommends be made 

available to interested parties to assist in 

the development and maintenance of 

drug dictionaries. The draft guidance 

outlines each data element and provides 

recommended standards for the data 

elements. The draft guidance addresses 

medicinal products (drugs and 

biologics) and is intended to accomplish 

the following goals: 

• Improve the exchange of medicinal 

product information, 

• Improve consistency in evaluating 

and comparing medicinal products for 

postmarketing surveillance activities, 

• Provide consistent terminology for 

the health care community, and 

• Reduce administrative burdens for 

the pharmaceutical industry when 

complying with different regional 

regulatory requirements. 

The draft guidance refers to approved 

medicinal products. The draft guidance 

does not apply to homeopathic 

medicinal products or investigational 

medicinal products. The draft guidance 

does not cover the establishment and 

maintenance of a drug dictionary. 

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 M5 data elements and standards for 

drug dictionaries. 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. 

53022 Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Notices 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. 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. The draft guidance and 

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 http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, http://www.fda.gov/cder/ 

guidance/index.htm, or http:// 

www.fda.gov/cber/reading.htm. 

Dated: August 29, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17597 Filed 9–2–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

ACTION: Notice and request for 

comments. 

SUMMARY: The Federal Emergency 

Management Agency, as part of its 

continuing effort to reduce paperwork 

and respondent burden, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on proposed information 

collections. In accordance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3506(c)(2)(A)), this notice seeks 

comments concerning information 

required by FEMA to amend or revise 

National Flood Insurance Program Maps 

to remove certain property from the 1- 

percent annual chance floodplain. 

SUPPLEMENTARY INFORMATION. With the 

passage of the Flood Disaster Protection 

Act of 1973, an owner of a structure, 

with a federally backed mortgage, 

located in the 1-percent annual chance 

floodplain, was required to purchase 

federal flood insurance. This was in 

response to the escalating damage 

caused by flooding and the 

unavailability of flood insurance from 

commercial insurance companies. As 

part of this effort, FEMA mapped the 1- 

percent annual chance floodplain in 

communities. However, due to scale 

limitations, individual structures that 

may be above the base flood cannot 

always be shown as being out of the 1- 

percent annual chance floodplain. 

FEMA will issue a Letter of Map 

Amendment (LOMA) or a Letter of Map 

Revision—Based on Fill (LOMR–F) to 

waive the Federal requirement for flood 

insurance when data is submitted to 

show that the property or structure is 

‘‘reasonably safe from flooding’’ and at 

or above the elevation of the base flood. 

Collection of Information 

Title: Right to Submit Technical or 

Scientific Data to Correct Mapping 

Deficiencies. 

Type of Information Collection: 

Revision of a Currently Approved 

Collection. 

OMB Number: 1660–0015. 

Form Numbers: FEMA Forms 81–87, 

81–87A, 81–87B. 

Abstract: The certification forms 

(referred to as MT–1 series forms) are 

designed to assist requesters in 

gathering information that FEMA needs 

to determine whether a certain property 

is likely to be flooded during the flood 

event that has a 1-percent annual 

chance of being equaled or exceeded in 

any given year (base flood). FEMA Form 

81–87, Property Information, describes 

the location of the property, what is 

being requested, and what data are 

required to support the request. FEMA 

Form 81–87A, Elevation Information, 

indicates what the Base (1-percent 

annual chance) Flood Elevation (BFE) 

for the property is, how the BFE was 

determined, the lowest ground elevation 

on the property, and/or the elevation of 

the lowest adjacent grade to any 

structures on the property. This 

information is required in order for 

FEMA to determine if the property that 

the requester would like removed from 

the SFHA FEMA Form 81–87B, 

Community Acknowledgment, requires 

that a community official certify that the 

request complies with minimum 

floodplain management criteria 

specified in 44 CFR 60.3, as per NFIP 

regulations 44 CFR 65.5(a)(4). 

Estimated Total Annual Burden 

Hours: 57,300. 

ANNUAL BURDEN HOURS

Project/activity (survey, form(s), focus group, etc.) 

Number of 

respondents 

(A) 

Frequency of 

responses 

(B) 

Burden hours 

per respondent 

(C) 

Annual 

responses 

(A × B) 

Total annual 

burden hours 

(A × B × C) 

81–87 ................................................................................ 18,272 Annual (1) ......... 1.63 18,272 29,783 

81–87A .............................................................................. 18,272 Annual (1) ......... 1.25 18,272 22,840 

81–87B .............................................................................. 3,389 Annual (1) ......... 1.38 3,389 4,677 

Total ........................................................................... 39,933 ........................... 4.26 39,933 57,300 

Estimated Cost. Cost to respondents is 

estimated to be $1,325,597 annually, 

while the cost to the Federal 

Government is estimated to be $94,300 

annually. 

Comments: Written comments are 

solicited to (a) evaluate whether the 

proposed data collection is necessary for 

the proper performance of the agency, 

including whether the information shall 

have practical utility; (b) evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) minimize the burden 

of the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses. Comments should be 

received within 60 days of the date of 

this notice. 

ADDRESSES: Interested persons should 

submit written comments to Chief, 

Records Management Section, 

Information Resources Management 

Branch, Information Technology