13498 Federal Register / Vol. 72, No. 55 / Thursday, March 22, 2007 / Notices 

Parkway, Cincinnati, OH 45226 (513) 

533–8370. 

Dated: March 14, 2007. 

James D. Seligman, 

Chief Information Officer, Center for Disease 

Control and Prevention. 

[FR Doc. E7–5219 Filed 3–21–07; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0092] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Food and 

Drug Administration Rapid Response 

Surveys 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the use of rapid response surveys to 

obtain data on safety information to 

support quick-turnaround 

decisionmaking about potential safety 

problems or risk management solutions 

from health care professionals, hospitals 

and other user-facilities (e.g., nursing 

homes, etc.); consumers; manufacturers 

of biologics, drugs, and medical devices; 

distributors; and importers when FDA 

must quickly determine whether or not 

a problem with a biologic, drug, or 

medical device impacts the public 

health. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 21, 2007. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (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 Food and Drug Administration 

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; 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. 

FDA estimates the burden of this 

collection of information as follows: 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 55 / Thursday, March 22, 2007 / Notices 13499 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

200 30 6,000 .5 3,000 

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

FDA projects 30 emergency risk 

related 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 one 

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: March 15, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5195 Filed 3–21–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0527] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Threshold of 

Regulation for Substances Used in 

Food-Contact Articles 

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 April 23, 

2007. 

ADDRESSES: 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: FDA Desk Officer, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

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. 

Threshold of Regulation for Substances 

Used in Food-Contact Articles (OMB 

Control Number 0910–0298)—Extension 

Under section 409(a) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 348(a)), the use of a food 

additive is deemed unsafe unless one of 

the following is applicable: (1) It 

conforms to an exemption for 

investigational use under section 409(j) 

of the act, (2) it conforms to the terms 

of a regulation prescribing its use, or (3) 

in the case of a food additive which 

meets the definition of a food-contact 

substance in section 409(h)(6) of the act, 

there is either a regulation authorizing 

its use in accordance with section 

409(a)(3)(A) or an effective notification 

in accordance with section 409(a)(3)(B). 

The regulations in § 170.39 (21 CFR 

170.39) established a process that 

provides the manufacturer with an 

opportunity to demonstrate that the 

likelihood or extent of migration to food 

of a substance used in a food-contact 

article is so trivial that the use need not 

be the subject of a food additive listing 

regulation or an effective notification. 

The agency has established two 

thresholds for the regulation of 

substances used in food-contact articles. 

The first exempts those substances used 

in food-contact articles where the 

resulting dietary concentration would 

be at or below 0.5 part per billion (ppb). 

The second exempts regulated direct 

food additives for use in food-contact 

articles where the resulting dietary 

exposure is 1 percent or less of the 

acceptable daily intake for these 

substances. 

In order to determine whether the 

intended use of a substance in a foodcontact article meets the threshold 

criteria, certain information specified in 

§ 170.39(c) must be submitted to FDA. 

This information includes the following 

components: (1) The chemical 

composition of the substance for which 

the request is made, (2) detailed 

information on the conditions of use of 

the substance, (3) a clear statement of 

the basis for the request for exemption 

from regulation as a food additive, (4) 

data that will enable FDA to estimate 

the daily dietary concentration resulting 

from the proposed use of the substance, 

(5) results of a literature search for 

toxicological data on the substance and 

its impurities, and (6) information on 

the environmental impact that would 

result from the proposed use. 

FDA uses this information to 

determine whether the food-contact 

article meets the threshold criteria. 

Respondents to this information 

collection are individual manufacturers 

and suppliers of substances used in 

food-contact articles (i.e., food 

packaging and food processing 

equipment) or of the articles themselves. 

In the Federal Register of January 8, 

2007 (72 FR 792), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 


rwilkins on PROD1PC63 with NOTICES