62404 Federal Register / Vol. 75, No. 195 / Friday, October 8, 2010 / Notices 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 8–1099, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail a copy 

to summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: September 30, 2010. 

Elaine Parry, 

Director, Office of Management, Technology 

and Operations. 

[FR Doc. 2010–25439 Filed 10–7–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Financial Institution Data 

Match. 

OMB No.: 0970–0196. 

Description: Section 466(a)(17) of the 

Social Security Act (the Act) requires 

States to establish procedures under 

which the State Child Support 

Enforcement IV–D agencies shall enter 

into agreements with financial 

institutions doing business in States for 

the purpose of securing information 

leading to the enforcement of child 

support orders. Under 452(l) and 

466(a)(17)(A)(i) of the Act, the Secretary 

may aid State agencies conducting data 

matches with financial institutions 

doing business in multiple States by 

centrally matching through the Federal 

Parent Locator Service. 

Respondents: Financial institutions 

doing business in two or more States. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Financial Data Match Result File .................................................................. 259 4 0.33 341 .88 

Election Form ................................................................................................. 122 1 0.50 61 

Estimated Total Annual Burden Hours ................................................... ........................ ........................ ........................ 402 .88 

Additional Information: Copies of the 

proposed collection may be obtained 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. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: October 5, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–25414 Filed 10–7–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0493] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Additional Criteria 

and Procedures for Classifying Overthe-Counter Drugs as Generally 

Recognized as Safe and Effective and 

Not Misbranded 

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 and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the additional criteria and procedures 

for classifying over-the-counter (OTC) 

drugs as generally recognized as safe 

and effective and not misbranded. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 7, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. 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: 

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: 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 

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 


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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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