Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78251 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant, Commissioner for Policy. 

[FR Doc. 2010–31380 Filed 12–14–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0380] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

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 January 14, 

2011. 

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: 

202–395–7285, or e-mailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0500. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850. 301–796– 

5156. Daniel.Gittleson@fda.hhs.gov. 

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. 

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 FD&C 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 FD&C Act (21 U.S.C. 372) authorizes 

investigational powers to FDA for 

enforcement of the FD&C Act. Under 

section 519 of the FD&C Act (21 U.S.C. 

360i), FDA is authorized to require 

manufacturers to report medical devicerelated 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 FD&C 

Act (21 U.S.C. 360l) authorizes FDA to 

require manufacturers to conduct 

postmarket surveillance of medical 

devices. Section 705(b) of the FD&C 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 

FD&C 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 FD&C 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 projects 6 emergency risk related 

surveys per year with a sample of 

between 50 and 10,000 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 

may be able to obtain by working with 

health care professional organizations. 

The annual number of surveys was 

determined by the maximum number of 

surveys per year FDA has ever 

conducted under this collection. 

In the Federal Register of August 6, 

2010 (75 FR 47599), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response 

Total 

hours 

10,000 .............................................................................................................. 2 6 60,000 .5 30,000 

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

2 Maximum. 


hsrobinson on DSK69SOYB1PROD with NOTICES
78252 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31381 Filed 12–14–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0418] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Institutional 

Review Boards 

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 January 14, 

2011. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0130. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850,. 301– 

796–3792. 

Elizabeth.Berbakos@fda.hhs.gov. 

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. 

Institutional Review Boards—OMB 

Control Number 0910–0130—Extension 

When reviewing clinical research 

studies regulated by FDA, institutional 

review boards (IRBs) are required to 

create and maintain records describing 

their operations, and make the records 

available for FDA inspection when 

requested. These records include: 

Written procedures describing the 

structure and membership of the IRB 

and the methods that the IRB will use 

in performing its functions; the research 

protocols, informed consent documents, 

progress reports, and reports of injuries 

to subjects submitted by investigators to 

the IRB; minutes of meetings showing 

attendance, votes and decisions made 

by the IRB, the number of votes on each 

decision for, against, and abstaining, the 

basis for requiring changes in or 

disapproving research; records of 

continuing review activities; copies of 

all correspondence between 

investigators and the IRB; statement of 

significant new findings provided to 

subjects of the research; and a list of IRB 

members by name, showing each 

member’s earned degrees, representative 

capacity, and experience in sufficient 

detail to describe each member’s 

contributions to the IRB’s deliberations, 

and any employment relationship 

between each member and the IRB’s 

institution. This information is used by 

FDA in conducting audit inspections of 

IRBs to determine whether IRBs and 

clinical investigators are providing 

adequate protections to human subjects 

participating in clinical research. 

In the Federal Register of August 17, 

2010 (75 FR 50766), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received regarding the information 

collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

recordkeeper Total hours 

56.115 ........................................................................ 2,500 14.6 36,500 100 3,650,000 

Total .................................................................... .......................... .......................... .......................... .......................... 3,650,000 

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

The recordkeeping requirement 

burden is based on the following: The 

burden for each of the paragraphs under 

21 CFR 56.115 has been considered as 

one estimated burden. FDA estimates 

that there are approximately 2,500 IRBs. 

The IRBs meet on an average of 14.6 

times annually. The agency estimates 

that approximately 100 hours of persontime per meeting are required to meet 

the requirements of the regulation. 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant, Commissioner for Policy. 

[FR Doc. 2010–31389 Filed 12–14–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0184] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study of Patient Information 

Prototypes 

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 January 14, 

2011. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–new and 

title ‘‘Experimental Study of Patient 

Information Prototypes.’’ Also include 


hsrobinson on DSK69SOYB1PROD with NOTICES