1890 Federal Register / Vol. 73, No. 7 / Thursday, January 10, 2008 / Notices 

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 into 

the environment. The primary purpose 

of this activity, which ATSDR has 

supported since 1992, is to develop, 

implement, and maintain a state-based 

surveillance system for hazardous 

substances emergency events which can 

be used to (1) describe the distribution 

of the hazardous substances releases; (2) 

describe the public health consequences 

(morbidity, mortality, and evacuations) 

associated with the events; (3) develop 

strategies to reduce future public health 

consequences. The study population 

will consist of all hazardous substance 

non permitted acute releases within the 

14 states (Colorado, Florida, Iowa, 

Louisiana, Michigan, Minnesota, New 

Jersey, New York, North Carolina, 

Oregon, Texas, Utah, Washington, and 

Wisconsin) participating in the 

surveillance system. 

Until this system was developed and 

implemented, there was no national 

public health-based surveillance system 

to coordinate the collation, analysis, and 

distribution of hazardous substances 

emergency release data to public health 

practitioners. It was necessary to 

establish this national surveillance 

system which describes the public 

health impact of hazardous substances 

emergencies on the health of the 

population of the United States. The 

data collection form will be completed 

by the state health department 

Hazardous Substances Emergency 

Events Surveillance (HSEES) 

coordinator using a variety of sources 

including written and oral reports from 

environmental protection agencies, 

police, firefighters, emergency response 

personnel; or researched by the HSEES 

coordinator using material safety data 

sheets, and chemical handbooks. There 

is a reduction in the annual burden 

hours per response because of the 

reduction in number of states from 15 to 

14 and because of a change in the case 

definition of an HSEES event in 2005, 

which excludes stack emissions of 

oxides of nitrogen (NOX), oxides of 

sulfur (SOx), and carbon monoxide (CO) 

when they are not mixed with another 

hazardous substance. 

The HSEES public use data set is 

available on the ATSDR HSEES Web 

site. Interested parties complete a brief 

description of who will be using the 

data and for what purpose in order to 

download the data. This allows ATSDR 

to widely distribute the data and track 

its usefulness. 

There is no cost to the respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per response 

(in hours) 

Total burden 

(in hours) 

Participating State Health Department HSEES Coordinators ......................... 14 536 45/60 5,628 

Persons interested in HSEES data through Web site ..................................... 500 1 6/60 50 

Total .......................................................................................................... 514 ........................ ........................ 5,678 

Dated: January 4, 2008. 

Marilyn S. Radke, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E8–270 Filed 1–9–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0493] 

International Conference on 

Harmonisation; Draft Guidance on 

Q8(R1) Pharmaceutical Development; 

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 

‘‘Q8(R1) Pharmaceutical Development 

Revision 1.’’ 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 is an annex to the 

parent ICH guidance entitled ‘‘Q8 

Pharmaceutical Development’’ (71 FR 

29344, May 22, 2006) (ICH Q8). It 

provides further clarification of key 

concepts outlined in ICH Q8 and 

describes the principles of quality by 

design (QbD). The draft guidance is 

intended to show how concepts and 

tools (e.g., design space) outlined in ICH 

Q8 could be put into practice by the 

applicant for all dosage forms. 

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 comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by April 9, 2008. 

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 either 

http://www.fda.gov/dockets/ecomments 

or http://www.regulations.gov. 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 CBER 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 

and other guidances mentioned in this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Moheb Nasr, 

Center for Drug Evaluation and Research 

(HFD–800), Food and Drug 

Administration, 10903 New Hampshire 

Ave., bldg. 21, rm. 2630, Silver Spring, 

MD 20993–0002, 301–796–1900; or 

Christopher Joneckis, Center for 

Biologics Evaluation and Research 

(HFM–20), Food and Drug 

Administration, 1401 Rockville Pike, 


yshivers on PROD1PC62 with NOTICES
Federal Register / Vol. 73, No. 7 / Thursday, January 10, 2008 / Notices 1891 

Rockville, MD 20852–1448, 301–435–

5681. 

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 the ICH 

sponsors and IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In November 2007, the ICH steering 

committee agreed that a draft guidance 

entitled ‘‘Q8(R1) Pharmaceutical 

Development Revision 1’’ should be 

made available for public comment. The 

draft guidance is the product of the 

Quality Expert Working Group of the 

ICH. Comments about this draft will be 

considered by FDA and the Quality 

Expert Working Group. 

The draft guidance is an annex to the 

parent guidance ICH Q8. It provides 

further clarification of key concepts 

outlined in ICH Q8 and describes the 

principles of QbD. The annex is not 

intended to establish new standards or 

increase regulatory expectations. It is 

intended to show how concepts and 

tools (e.g., design space) outlined in ICH 

Q8 could be put into practice by the 

applicant for all dosage forms. Where a 

company chooses to apply QbD and 

quality risk management (see ICH ‘‘Q9 

Quality Risk Management’’), linked to 

an appropriate pharmaceutical quality 

system (see ICH ‘‘Q10 Pharmaceutical 

Quality Systems’’), then opportunities 

arise to enhance science- and risk-based 

regulatory approaches. 

The draft guidance outlines the 

elements that should be included in 

pharmaceutical development and 

additional elements when QbD 

principles are applied. It elaborates, by 

means of description and example, 

possible approaches to gaining a more 

systematic, enhanced understanding of 

the product and process under 

development. The draft guidance also 

provides recommendations on the 

placement of pharmaceutical 

development and other related 

information in module 3 of a regulatory 

submission in the common technical 

document format. 

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 this topic. 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. 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 in January 2008, the 

FDA Web site is expected to transition 

to the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. After the transition 

date, electronic submissions will be 

accepted by FDA through the FDMS 

only. When the exact date of the 

transition to FDMS is known, FDA will 

publish a Federal Register notice 

announcing that date. 

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/publications.htm. 

Dated: January 2, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–213 Filed 1–9–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2007–29070] 

Collection of Information Under 

Review by Office of Management and 

Budget: OMB Control Number 1625–

0108 

AGENCY: Coast Guard, DHS. 

ACTION: Thirty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, this 

request for comments announces that 

the U.S. Coast Guard is forwarding an 

Information Collection Request (ICR), 

abstracted below, to the Office of 

Information and Regulatory Affairs 

(OIRA) of the Office of Management and 

Budget (OMB) requesting an extension 

of their approval for the following 

collection of information: 1625–0108, 

Standard Numbering System for 

Undocumented Vessels. Our ICR 

describes the information we seek to 

collect from the public. Review and 

comments by OIRA ensure we only 

impose paperwork burdens 

commensurate with our performance of 

duties. 

DATES: Please submit comments on or 

before February 11, 2008. 

ADDRESSES: To make sure your 

comments and related material do not 

enter the Coast Guard docket [USCG–

2007–29070] or are received by OIRA 

more than once, please submit them by 

only one of the following means: 

(1) Electronic submission. (a) To Coast 

Guard docket at http:// 

www.regulations.gov. (b) To OIRA by email to: nlesser@omb.eop.gov. 


yshivers on PROD1PC62 with NOTICES