Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices 58317 

burden of the collection on respondents, 

including through the use of automated 

collection techniques, when 

appropriate, and other forms of 

information technology. 

Title: Postmarketing Adverse Event 

Reporting and Recordkeeping for 

Nonprescription Human Drug Products 

Marketed Without an Approved 

Application as Required by the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers, packers, 

and distributors whose name (pursuant 

to section 502(b)(1) of the act) appears 

on the label of a nonprescription drug 

marketed in the United States. 

Burden Estimate: FDA is requesting 

public comment on estimates of annual 

submissions from these respondents, 

expected in 2008, as required by Public 

Law 109–462 and described in this 

guidance. This guidance document 

discusses what should be included in a 

serious adverse drug event report 

submitted under section 760(b)(1) of the 

act, including follow-up reports under 

760(c)(2) of the act, and how to submit 

these reports. The estimates for annual 

reporting burden and recordkeeping are 

based on FDA’s knowledge of adverse 

drug experience reports historically 

submitted per year for prescription drug 

products and for nonprescription drug 

products marketed under an approved 

application, including knowledge about 

the time needed to prepare the reports 

and to maintain records. 

FDA receives approximately 2,500 

serious adverse event reports for 

nonprescription drug products marketed 

under approved applications, which 

comprise approximately 20 percent of 

the overall nonprescription drug market. 

Based on this experience, we estimate 

between 10,000 and 15,000 (i.e., 12,500) 

total annual responses for 

nonprescription drugs marketed without 

an approved application. FDA estimates 

the burden of this collection of 

information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

No. of 

respondents 

Annual frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

Reports of serious adverse drug 

events (21 U.S.C. 379aa((b) 

and (c)) 50 250 12,500 2 25,000 

Total 25,000 

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

Section 760(e) of the act also requires 

that responsible persons maintain 

records of nonprescription adverse 

event reports, whether or not the event 

is serious, for a period of 6 years. The 

draft guidance recommends that 

responsible persons maintain records of 

efforts to obtain the minimum data 

elements for a report of a serious 

adverse drug event and any followup 

reports. Although the guidance does not 

provide recommendations on 

recordkeeping activities generally under 

section 760(e) of the act, FDA is 

providing an estimate for the burden of 

this collection. Historically, serious 

adverse event reports comprise 

approximately two-thirds, and 

nonserious adverse event reports 

comprise approximately one-third, of 

the total number of postmarketing 

adverse event reports associated with 

drugs and biologic therapeutics (except 

vaccines) received by FDA. Based on 

this generalization, FDA estimates the 

total annual records to be approximately 

20,000 records per year. FDA estimates 

that it takes 5 hours to maintain each 

record and the recordkeeping burden as 

follows: 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

No. of 

recordkeepers 

Annual frequency 

per recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

Recordkeeping (21 U.S.C. 

379aa(e)(1)) 200 100 20,000 5 100,000 

Total 100,000 

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

Therefore, the estimated annual 

reporting burden for this information is 

25,000 hours, and the estimated annual 

recordkeeping burden is 100,000 hours. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: October 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–5073 Filed 10–11–07; 11:34 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

Part M of the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) Statement of Organization, 

Functions, and Delegations of Authority 

for the Department of Health and 

Human Services at 72, Number 188, 

page 55232, September 28, 2007, is 


sroberts on PROD1PC70 with NOTICES
58318 Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices 

amended to reflect changes to the 

structure and functional statements for 

the Office of Program Services (OPS), 

Division of Management Systems 

(DMS). This amendment reflects the 

deletion of references to the information 

technology (IT) functions within the 

functional statement of DMS. In 

addition, it reflects the establishment of 

a new Division of Technology 

Management (DTM), within OPS. These 

changes will strengthen the 

management of this key function (IT) 

and provide better customer service and 

program coordination. The changes are 

as follows: 

Section M.20, Functions is amended 

as follows: 

The functional statements for the 

Office of Program Services (OPS), 

Division of Management Systems (DMS) 

is replaced, and a new functional 

statement within OPS is established for 

the new Division of Technology 

Management (DTM). 

Division of Management Systems (MBC) 

(1) Provides leadership in the 

development of policies for and the 

analysis, performance measurement, 

and improvement of SAMHSA 

administrative and management 

systems; (2) coordinates with other 

service providers the provision of 

human resource management services, 

equal employment opportunity services, 

and personnel security services, 

working with HHS service components 

and outside organizations as necessary 

and monitoring their performance; (3) 

manages the SAMBHSA ethics program; 

(4) coordinates and serves as a focal 

point for SAMHSA intern and summer 

employment programs; (5) provides 

advisory services to managers and 

supervisors in such matters as 

organizational development, analysis, 

performance, and performance 

measurement; (6) coordinates General 

Accounting Office and Office of the 

Inspector General reviews and 

information requests, internal control 

reviews, and Federal Managers 

Financial Integrity Act responses; (7) 

plans and coordinates various 

management activities such as records 

management, forms management, 

Privacy Act, and OPS Freedom of 

Information Act requests; (8) 

coordinates the Competitive Sourcing 

program for the agency, including the 

annual Federal Activities Inventory 

Reform Act (FAIR Act) Inventory, and 

activities and studies conducted in 

accordance in OMB Circular A–76, 

regarding competition of commercial 

activities; (9) develops, maintains, and 

manages administrative management 

systems regarding policies and 

procedures. 

Division of Technology Management 

(MBJ) 

(1) Provides leadership in the 

development of policies for and the 

analysis, performance measurement, 

and improvement of SAMHSA 

information systems; (2) Manages, 

operates, and enhances SAMHSA-wide 

administrative applications software 

systems; (3) coordinates with other 

service providers the provision of IT 

services, including operation of the 

local and wide area networks, personal 

computers, network servers, electronic 

mail and faxes, and general computer 

repairs, working with HHS service 

components and outside organizations 

as necessary and monitoring their 

performance; (4) serves as the Agency 

focal point for IT policy, strategic 

planning, budget preparation, 

coordination with the Department 

regarding these issues, and the 

submission of required reports to the 

Department on a timely basis; (5) makes 

certain that the appropriate level of IT 

security is in place so that the safety of 

Agency data can be assured; (6) oversees 

Agency-wide database administration 

and systems configuration management, 

providing advice, assistance, and 

training to Agency staff to obtain 

maximum utilization of and services 

from its information/application 

systems and databases; (7) exercises 

clearance authority for Agency IT 

management projects; and (8) reviews 

and analyzes new IT management 

developments and ensures necessary 

support services are provided. 

Delegation of Authority 

All delegations and redelegations of 

authority to officers and employees of 

SAMHSA which were in effect 

immediately prior to the effective date 

of this reorganization shall continue to 

be in effect pending further 

redelegations, providing they are 

consistent with the reorganization. 

These organizational changes are effective: 

October 9, 2007. 

Terry L. Cline, 

Administrator. 

[FR Doc. 07–5060 Filed 10–12–07; 8:45 am] 

BILLING CODE 4160–01–M 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–566, Extension of an 

Existing Information Collection; 

Comment Request 

ACTION: 30-Day Notice of Information 

Collection Under Review: Form I–566, 

Interagency Record of Individual 

Requesting Change/Adjustment to or 

From A or G Status or Requesting A, G, 

or NATO Dependent Employment 

Authorization; OMB Control No. 1615–

0027. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) has 

submitted the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection was 

previously published in the Federal 

Register on July 30, 2007, at 72 FR 

41515. The notice allowed for a 60-day 

public comment period. No comments 

were received on this information 

collection. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted until November 14, 

2007. This process is conducted in 

accordance with 5 CFR 1320.10. 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the 

Department of Homeland Security 

(DHS), USCIS, Chief, Regulatory 

Management Division, Clearance Office, 

111 Massachusetts Avenue, 3rd floor, 

Washington, DC 20529. Comments may 

also be submitted to DHS via facsimile 

to 202–272–8352 or via e-mail at 

rfs.regs@dhs.gov, and to the OMB USCIS 

Desk Officer via facsimile at 202–395–

6974 or via e-mail at 

kastrich@omb.eop.gov. 

When submitting comments by e-mail 

please make sure to add OMB Control 

Number 1615–0027 in the subject box. 

Written comments and suggestions from 

the public and affected agencies should 

address one or more of the following 

four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 


sroberts on PROD1PC70 with NOTICES