1620 Federal Register / Vol. 76, No. 7 / Tuesday, January 11, 2011 / Notices 

review process to inform their own 

system development efforts. 

No small businesses will be involved 

in this data collection effort. 

Respondents: Title IV–E Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

SACWIS Assessment Review Guide (SARG) ................................................. 3 1 250 750 

Estimated Total Annual Burden 

Hours: 750. 

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. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–332 Filed 1–10–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0637] 

Trials to Verify and Describe Clinical 

Benefit of Midodrine Hydrochloride; 

Establishment of Public Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

opening of a public docket to provide a 

forum to facilitate communication 

regarding the conduct of clinical trials 

needed to verify and describe the 

clinical benefit of midodrine 

hydrochloride (HCl) when used to treat 

symptomatic orthostatic hypotension. 

DATES: Submit either electronic or 

written comments by July 11, 2011. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments 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: Wei 

Lu, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6196, Silver Spring, 

MD 20993–0002, e-mail: 

Wei.Lu@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA 

approved PROAMATINE (midodrine 

HCl) for marketing under its accelerated 

approval regulations, 21 CFR part 314, 

subpart H, on September 6, 1996, to 

treat patients with symptomatic 

orthostatic hypotension. Since that time, 

FDA has approved five generic versions 

of this product. Orthostatic hypotension 

is a condition in which patients are 

unable to maintain blood pressure in the 

upright position and become dizzy or 

faint upon standing. Subpart H allows 

approval of drugs to treat serious or lifethreatening illnesses based on adequate 

and well-controlled clinical trials 

establishing that the drug has an effect 

on a surrogate endpoint that is 

reasonably likely to predict clinical 

benefit or based on a clinical endpoint 

other than survival or irreversible 

morbidity. Approval of PROAMATINE 

was based on trials demonstrating that 

PROAMATINE increased 1-minute 

standing systolic blood pressure, a 

surrogate marker considered likely to 

correspond to a clinical benefit, 

principally relief of symptoms of 

orthostatic hypotension and improved 

ability to perform life activities. 

The subpart H regulations specify that 

approvals based upon surrogate 

endpoints are ‘‘subject to the 

requirement that the applicant study the 

drug further to verify and describe its 

clinical benefit’’ in postmarketing 

studies. The postmarketing study 

requirement for midodrine HCl was 

described in the new drug application 

(NDA) submission seeking its approval 

and referenced in the Agency’s 1996 

approval letter. In the time since 

PROAMATINE was approved, the NDA 

holder has sponsored clinical trials and 

information regarding the drug’s 

efficacy has been published, but data 

submitted to the Agency have not 

verified the drug’s clinical benefit to 

FDA’s satisfaction. Accordingly, on 

August 16, 2010, FDA issued a notice of 

opportunity for a hearing (NOOH) on a 

proposal to withdraw approval of the 

NDA for midodrine HCl. 

Although the NOOH process is 

proceeding on a separate track, FDA 

recognizes that existing and potential 

sponsors may wish to conduct the 

clinical trials needed to support 

continued marketing authorization of 

midodrine HCl. To assist sponsors in 

planning and designing such trials, we 

are placing in the docket a brief 

description of a recommended clinical 

trial design. We are also inviting 

interested parties to submit information 

to the docket such as any existing 

controlled studies that verify the 

clinical benefit of midodrine HCl when 

used to treat orthostatic hypotension. 

Physicians who treat orthostatic 

hypotension and patient organizations 

that would like to work with any 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 7 / Tuesday, January 11, 2011 / Notices 1621 

sponsors of new clinical trials are 

invited to submit correspondence to the 

docket identifying themselves. We 

anticipate that any sponsor planning to 

conduct new clinical studies may 

contact interested physicians and 

organizations to solicit information and 

suitable volunteer test subjects. 

The public docket is available for 

public review in the Division of Dockets 

Management (see ADDRESSES) between 9 

a.m. and 4 p.m., Monday through 

Friday. 

Dated: January 6, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–355 Filed 1–10–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; NIH Toolbox for Assessment 

of Neurological and Behavioral 

Function 

SUMMARY: In compliance with the 

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

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute on Aging (NIA), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: NIH 

Toolbox for Assessment of Neurological 

and Behavioral Function. Type of 

Information Collection Request: New. 

Need and Use of Information Collection: 

The overall goal of the NIH Toolbox 

project is to develop unified, integrated 

methods and measures of four domains 

of neurological and behavioral 

functioning (cognitive, emotional, motor 

and sensory) for use in large 

longitudinal or epidemiological studies 

where functioning is monitored over 

time. The current phase (‘‘Norming’’), 

will involve a large sample of 12,900 for 

the purpose of establishing comparative 

norms. Existing recruitment databases 

will be randomly sampled and screened 

for household members’ age, gender, 

race/ethnicity, education and primary 

language. The targeted population will 

be non-institutionalized U.S. residents, 

aged 3–85, with 70% English-speaking 

and 30% Spanish-speaking. Frequency 

of Response: Once or twice (depending 

on subsample). Affected Public: 

Individuals. Type of Respondents: U.S. 

residents (persons aged 3–85 years). The 

annual reporting burden is as follows: 

Estimated Number of Respondents: 

12,900; Estimated Number of Responses 

per Respondent: 1–2; Average Burden 

Hours per Response: 1.96; and 

Estimated Total Annual Burden Hours 

Requested: 29,700. The annualized cost 

to respondents is estimated at: $414,375. 

There are no Capital Costs, Operating 

Costs, and/or Maintenance Costs to 

report. 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated total 

annual burden 

hours 

requested 

Adults * 

Adult study participants, single assessment .................................................... 3,150 1 3 9,450 

Adult study participants, two assessments ...................................................... 750 2 3 4,500 

Parent proxies for child participants, single assessment ................................ 3,750 1 0.5 1,875 

Parent proxies for child participants, two assessments .................................. 750 2 0.5 750 

Children 

Single assessment ........................................................................................... 3,750 1 2.5 9,375 

Two assessments ............................................................................................ 750 2 2.5 3,750 

Totals ........................................................................................................ * 12,900 ........................ ........................ 29,700 

* Some adults may participate both as a study participant and as a parent proxy if their child is also a study participant. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Eddie Billingslea, 

PhD, Division of Neuroscience, National 

Institute on Aging, NIH, DHHS, 7201 

Wisconsin Avenue, Suite 350, Bethesda, 

Maryland 20892–9205 or call non-tollfree number 301–496–9350 or e-mail 

your request, including your address to: 

billingsleae@nia.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: January 4, 2011. 

Melissa Fraczkowski, 

National Institute on Aging, Project Clearance 

Liaison, National Institutes of Health. 

[FR Doc. 2011–379 Filed 1–10–11; 8:45 am] 

BILLING CODE 4140–01–P 

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