Federal Register / Vol. 75, No. 195 / Friday, October 8, 2010 / Notices 62405 

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. 

Additional Criteria and Procedures for 

Classifying OTC Drugs as Generally 

Recognized as Safe and Effective and 

Not Misbranded—New 

In the Federal Register of January 23, 

2002 (67 FR 3060), we established 

regulations in § 330.14 (21 CFR 330.14) 

providing additional criteria and 

procedures for classifying OTC drugs as 

generally recognized as safe and 

effective and not misbranded (2002 TEA 

final rule). The regulations in § 330.14 

state that OTC drug products introduced 

into the U.S. market after the OTC drug 

review began and OTC drug products 

without any marketing experience in the 

United States can be evaluated under 

the monograph process if the conditions 

(e.g., active ingredients) meet certain 

‘‘time and extent’’ criteria outlined in 

§ 330.14(b). The regulations allow a 

‘‘time and extent’’ application (TEA) to 

be submitted to us by any party for our 

consideration to include new conditions 

in the OTC drug monograph system. 

TEAs must provide evidence described 

in § 330.14(c) demonstrating that the 

condition is eligible for inclusion in the 

monograph system. (Section 330.14(d) 

specifies the number of copies and 

address for submission of a TEA.) If a 

condition is found eligible, any 

interested parties can submit safety and 

effectiveness information as explained 

in § 330.14(f). Safety and effectiveness 

data include not only the data and 

information listed in 21 CFR 

330.10(a)(2) (§ 330.14(f)(1)) but also a 

listing of all serious adverse drug 

experiences that may have occurred 

(§ 330.14(f)(2)) as well as an official or 

proposed compendial monograph 

(§ 330.14(i)). 

In the 2002 TEA final rule, we 

estimated that 50 TEAs would be 

submitted to us annually by 

approximately 25 respondents (67 FR 

3060 at 3073). We also estimated that 

the time required for preparing and 

submitting each TEA would be 

approximately 480 hours. We continue 

to believe that a respondent will spend 

approximately 480 hours preparing a 

TEA, but we no longer expect to receive 

50 TEAs annually. Since 2003, we have 

received a total of 16 TEAs from 12 

respondents. This is equivalent to 2.3 

TEAs annually from 1.7 respondents. 

We now estimate that we will receive 2 

TEAs annually from 2 respondents (see 

table 1 of this document). 

We also estimated in the 2002 TEA 

final rule that we would receive three 

safety and effectiveness submissions for 

each condition found eligible for further 

consideration under a TEA (67 FR 3060 

at 3072). We estimated that we would 

receive 90 submissions of safety and 

effectiveness data annually. And, we 

estimated that it would take 

approximately 800 hours to prepare and 

submit each safety and effectiveness 

submission. We believe that each 

submission, including serious adverse 

drug experiences and a compendial 

monograph, will take approximately 800 

hours to complete (see table 1 of this 

document). However, we do not believe 

the estimated number of submissions is 

accurate. During the 8 years that have 

elapsed since publication of the 2002 

TEA final rule, we have found 14 

ingredients eligible under the TEA 

process and have received 16 

submissions of safety and effectiveness 

data from 9 respondents. Therefore, we 

now estimate that we will receive two 

submissions of safety and effectiveness 

data annually from two respondents. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

330.14(c) and (d) 1 ............................................................... 2 1 2 480 960 

330.14(f) and (i) 2 ................................................................. 2 1 2 800 1,600 

Total .............................................................................. ........................ ........................ ........................ ........................ 2,560 

1TEA. 

2Safety and effectiveness submission, including adverse events and compendial monograph. 

Dated: October 3, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25375 Filed 10–7–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[OMB No. 0970–0171] 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Required Data Elements for 

Voluntary Establishment of Paternity 

Affidavits. 

Description: Section 466(a)(5)(C)(iv) of 

the Social Security Act (the Act) 

requires States to develop and use an 

affidavit for the voluntary 

acknowledgement of paternity. The 

affidavit for the voluntary 

acknowledgement of paternity must 

include the minimum requirements 

specified by the Secretary under section 

452(a)(7) of the Act. The affidavits will 

be used by hospitals, birth record 

agencies, and other entities participating 

in the voluntary paternity establishment 

program, that collect information from 

parents of children that are born out of 

wedlock. 

Respondents: Parents of children that 

are born out of wedlock provide the 

required information to State and Tribal 

IV–D agencies, hospitals, birth record 

agencies and other entities participating 


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62406 Federal Register / Vol. 75, No. 195 / Friday, October 8, 2010 / Notices 

in the voluntary paternity establishment 

program. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

None ................................................................................................................ 1,167,097 1 .166 193,738 

Estimated Total Annual Burden 

Hours: 193,738. 

In compliance with the requirements 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; 

(c) the quality, utility, and clarity of the 

information to be collected; and 

(d) ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: September 29, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–25023 Filed 10–7–10; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Plan To Develop a Genetic Testing 

Registry at the National Institutes of 

Health; Public Meeting; Request for 

Comments 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The National Institutes of 

Health is announcing a public meeting 

to gather stakeholder perspectives on its 

plan to develop the Genetic Testing 

Registry. The meeting will provide a 

forum for interested stakeholders to 

provide comments on specific aspects of 

the plan. 

Date and Time: The public meeting 

will be held November 2, 2010, from 9 

a.m. to 12 p.m. 

Location: The public meeting will be 

held at the Walter E. Johnson 

Convention Center, Room 147, 801 

Mount Vernon Place, NW., Washington, 

DC 20001. For directions, please contact 

the Convention Center at 202–249–3000 

or refer to the following Web site: 

http://www.dcconvention.com/. 

Special accommodations: Anyone 

planning to attend the meeting who 

needs special assistance, such as sign 

language interpretation or other 

reasonable accommodations, is asked to 

contact Cathy Fomous (see Contacts 

section) by October 26, 2010. 

Registration: If you wish to attend the 

public meeting, please register by 

October 27, 2010. Registration is free 

and on a first-come, first-served basis. 

Pre-registration can be completed online 

at http://oba.od.nih.gov/gtr/ 

gtr_meetings.html. Persons without 

Internet access may call Ms. Nicole 

Numbers at 301–650–8660. Onsite 

registration will be based on space 

availability. 

Requests for Oral Presentations: 

Interested persons who would like to 

make oral comments during the meeting 

will be given 5 minutes to do so if they 

submit their request by October 27, 

2010, to Cathy Fomous. Send requests 

by e-mail to cfomous@od.nih.gov; by fax 

to 301–496–9839; or via postal service 

to Cathy Fomous, Ph.D., Office of 

Biotechnology Activities, National 

Institutes of Health, 6705 Rockledge Dr., 

Suite 750, Bethesda, MD 20892. The 

request should include the commenter’s 

name, title, affiliation, address, e-mail 

address, and telephone number. All 

requests should indicate which 

questions outlined below in the section 

on Public Meeting Focus will be 

addressed. Depending on the number of 

individuals and organizations that 

submit requests to make oral remarks, 

the allotted time may be expanded or 

shortened to provide all interested 

parties an opportunity to present. 

Written Comments: Interested persons 

who cannot attend the meeting may 

submit written comments on the 

questions outlined below. Comments 

should be submitted to Cathy Fomous 

via e-mail, fax, or postal service using 

the above contact information. The 

comment period for written comments 

closes on November 12, 2010. 

Contacts: For questions about the 

meeting logistics, please contact Ms. 

Nicole Numbers at 

numbers@palladianpartners.com or 

301–650–8660. For special 

accommodations or questions about the 

meeting agenda and public comments, 

please contact Cathy Fomous, Ph.D., 

NIH Office of Biotechnology Activities 

at cfomous@od.nih.gov or 301–496– 

9838. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Advances in the knowledge of genetic 

factors involved in health and disease 

have been accompanied by a rapid rise 

in the availability of genetic tests, 

including those tests that diagnose or 

assess the risk for disease, provide 

prognostic information, and guide the 

selection of drug therapies and dosing. 

Although more than 2,000 genetic tests 

are available, there is no public resource 

that provides centralized information 

about the availability and scientific 

basis of these tests. 

On March 18, 2010, the National 

Institutes of Health (NIH) announced its 

intent to develop the Genetic Testing 


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