13338 Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 

suppliers maintain in their records and 

make available to CMS and its agents 

upon request. Finally, this rule 

discusses CMS’ policy on 

documentation that may be requested by 

CMS and its agents to support a 

Medicare claim for payment. Form 

Number: CMS–10116 (OCN: 0938– 

0971); Frequency: Yearly; Affected 

Public: Private Sector—Business or 

other for-profits. Number of 

Respondents: 90,521. Number of 

Responses: 173,810. Total Annual 

Hours: 34,762. (For policy questions 

regarding this collection contact Susan 

Miller at 410–786–2118. For all other 

issues call 410–786–1326.) 

3. Type of Information Collection 

Request: New collection; Title of 

Information Collection: End Stage Renal 

Disease (ESRD) System Access Request 

Form; Use: Within CMS, the Office of 

Clinical Standards and Quality is 

developing a new suite of systems to 

support the End Stage Renal Disease 

(ESRD) program. Due to the sensitivity 

of the data being collected and reported, 

CMS must ensure that only authorized 

personnel have access to data. Personnel 

are given access to the ESRD systems 

through the creation of user IDs and 

passwords within the QualityNet 

Identity Management System (QIMS); 

however, once within the system, the 

system determines the rights and 

privileges the personnel has over the 

data within the system. 

The sole purpose the End Stage Renal 

Disease System (ESRD) System Access 

Request Form is to identify the 

individual’s data access rights once 

within the ESRD system. This function 

and the associated data collection is 

currently being accomplished under 

‘‘Part B’’ of the QualityNet Identity 

Management System Account Form 

(CMS–10267; OCN: 0938–1050). Once 

the ESRD System Access Form is 

approved, the QualityNet Identity 

Management System (QIMS) Account 

Form will be revised to remove Part B 

from the QIMS data collection. Form 

Number: CMS–10426 (OCN: 0938– 

New); Frequency: Yearly; Affected 

Public: Private Sector—Business or 

other for-profits. Number of 

Respondents: 25,000. Number of 

Responses: 25,000. Total Annual Hours: 

6,250. (For policy questions regarding 

this collection contact Michelle Tucker 

at 410–786–0736. For all other issues 

call 410–786–1326.) 

4. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Probable Fraud 

Measurement Pilot; Use: The Centers for 

Medicare & Medicaid Services (CMS) is 

seeking Office of Management and 

Budget (OMB) approval of the 

collections required for a probable fraud 

measurement pilot. The probable fraud 

measurement pilot would establish a 

baseline estimate of probable fraud in 

payments for home health care services 

in the fee-for-service Medicare program. 

CMS and its agents will collect 

information from home health agencies, 

the referring physicians and Medicare 

beneficiaries selected in a national 

random sample of home health claims. 

The pilot will rely on the information 

collected along with a summary of the 

service history of the HHA, the referring 

provider, and the beneficiary to estimate 

the percentage of total payments that are 

associated with probable fraud and the 

percentage of all claims that are 

associated with probable fraud for 

Medicare fee-for-service home health. 

Form Number: CMS–10406 (OCN: 

0938–New); Frequency: Yearly; Affected 

Public: Individual and Private Sector— 

Business or other for-profits. Number of 

Respondents: 6,000. Number of 

Responses: 6,000. Total Annual Hours: 

10,500. (For policy questions regarding 

this collection contact Kelly Gent at 

410–786–0918. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by May 7, 2012: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number lll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: March 1, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–5439 Filed 3–5–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Tribal Consultation Meetings 

AGENCY: Office of Head Start (OHS), 

Administration for Children and 

Families, HHS. 

ACTION: Notice of meetings. 

SUMMARY: Pursuant to the Improving 

Head Start for School Readiness Act of 

2007, Public Law 110–134, notice is 

hereby given of one-day Tribal 

Consultation Sessions to be held 

between the Department of Health and 

Human Services, Administration for 

Children and Families, Office of Head 

Start leadership and the leadership of 

Tribal Governments operating Head 

Start (including Early Head Start) 

programs. The purpose of these 

Consultation Sessions is to discuss ways 

to better meet the needs of American 

Indian and Alaska Native children and 

their families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations [42 U.S.C. 9835, 

Section 640(l)(4)]. 

DATES: March 22 and April 3, 2012. 

ADDRESSES: 2012 Office of Head Start 

Tribal Consultation Sessions will be 

held at the following locations: 

Thursday, March 22, 2012—Phoenix, 

Arizona—Sheraton Crescent Hotel, 2620 

West Dunlap Avenue Phoenix, AZ 

85021; Tuesday, April 3, 2012—Billings, 

Montana—Holiday Inn Grand Montana 

5500 Midland Road, Billings, MT 59101. 

FOR FURTHER INFORMATION CONTACT: 

Camille Loya, Acting Regional Program 

Manager Region XI, email 

Camille.Loya@acf.hhs.gov or phone 

(202) 401–5964. Additional information 

and online meeting registration is 

available at http:// 

www.headstartresourcecenter.org. 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) announces Office of 

Head Start (OHS) Tribal Consultations 

with leaders of Tribal Governments 

operating Head Start (including Early 

Head Start) programs for each of the 

nine geographic regions of Head Start 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13339 

1Before passage of the Food and Drug 

Administration Amendments Act of 2007 (FDAAA), 

FDA could require postmarketing studies and 

clinical trials under the following circumstances: 

To verify adn describe clinical benefit for a human 

drug approved in accordance with the accelerated 

approval provisions in section 506(b)(2)(A) of the 

FD&C Act (21 CFR 314.510 and 601.41); for a drug 

approved on the basis of animal efficacy data 

because human efficacy trials are not ethical or 

feasible (21 CFR 314.610(b)(1) and 601.91(b)(1)): 

and for marketed drugs that not adequately labeled 

for children under section 505B of the FD&C Act 

(Pediatric Research Equity Act (21 U.S.C. 355c; Pub. 

L. 108–155)). 

where American Indian and Alaska 

Native (AI/AN) programs are located. 

We are convening the OHS Tribal 

Consultations in conjunction with other 

Tribal Leader events in order to 

minimize the financial and travel 

burden for participants. The sessions in 

Phoenix, Arizona, and Billings, 

Montana, are being held in conjunction 

with the HHS 2012 Regional Tribal 

Consultation Sessions. We will schedule 

additional consultations around the 

country for later in the year. 

The agenda for the scheduled OHS 

Tribal Consultations will be organized 

around the statutory purposes of Head 

Start Tribal Consultations related to 

meeting the needs of AI/AN children 

and families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations. In addition, OHS 

will share actions taken and in progress 

to address the issues and concerns 

raised in 2011 OHS Tribal 

Consultations. 

Tribal leaders and designated 

representatives interested in submitting 

written testimony or proposing specific 

agenda topics for these Consultation 

Sessions should contact Camille Loya at 

Camille.Loya@acf.hhs.gov. Proposals 

must be submitted at least three days in 

advance of the session and should 

include a brief description of the topic 

area, along with the name and contact 

information of the suggested presenter. 

The Consultation Sessions will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives [42 

U.S.C.9835, Section 640(l)(4)(A)]. 

Designees must have a letter from the 

Tribal Government authorizing them to 

represent the tribe. The letter should be 

submitted at least three days in advance 

of the Consultation Session to Camille 

Loya at (202) 205–9721 (fax). Other 

representatives of tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of each Consultation 

Session will be prepared and made 

available within 90 days of the 

Consultation Session to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Camille Loya at 

Camille.Loya@acf.hhs.gov either prior to 

the Consultation Session or within 30 

days after the meeting. 

Oral testimony and comments from 

the Consultation Sessions will be 

summarized in each report without 

attribution, along with topics of concern 

and recommendations. Hotel and 

logistical information for all 

Consultation Sessions has been sent to 

tribal leaders via email and posted on 

the Head Start Resource Center Web site 

at http:// 

www.headstartresourcecenter.org. 

Dated: February 28, 2012. 

Yvette Sanchez Fuentes, 

Director, Office of Head Start. 

[FR Doc. 2012–5438 Filed 3–5–12; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0169] 

Report on the Performance of Drug 

and Biologics Firms in Conducting 

Postmarketing Requirements and 

Commitments; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: Under the Food and Drug 

Administration Modernization Act of 

1997 (Modernization Act), the Food and 

Drug Administration (FDA) is required 

to report annually in the Federal 

Register on the status of postmarketing 

requirements and commitments 

required of, or agreed upon by, holders 

of approved drug and biological 

products. This notice is the Agency’s 

report on the status of the studies and 

clinical trials that applicants have 

agreed to, or are required to, conduct. 

FOR FURTHER INFORMATION CONTACT: Meg 

Pease-Fye, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 4156, Silver Spring, 

MD 20993–0002, 301–796–0700; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The Modernization Act 

Section 130(a) of the Modernization 

Act (Pub. L. 105–115) amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) by adding a new 

provision requiring reports of certain 

postmarketing studies, including 

clinical trials, for human drug and 

biological products (section 506B of the 

FD&C Act (21 U.S.C. 356b)). Section 

506B of the FD&C Act provides FDA 

with additional authority to monitor the 

progress of a postmarketing study or 

clinical trial that an applicant has been 

required to, or has agreed to, conduct by 

requiring the applicant to submit a 

report annually providing information 

on the status of the postmarketing 

study/clinical trial. This report must 

also include reasons, if any, for failure 

to complete the study/clinical trial. 

These studies and clinical trials are 

intended to further define the safety, 

efficacy, or optimal use of a product, 

and therefore play a vital role in fully 

characterizing the product. 

Under the Modernization Act, 

commitments to conduct postmarketing 

studies or clinical trials included both 

studies/clinical trials that applicants 

agreed to conduct, as well as studies/ 

clinical trials that applicants were 

required to conduct under FDA 

regulations.1

B. The Food and Drug Administration 

Amendments Act of 2007 

On September 27, 2007, the President 

signed Public Law 110–85, the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA). Section 901, in Title 

IX of FDAAA, created a new section 

505(o) of the FD&C Act authorizing FDA 

to require certain studies and clinical 

trials for human drug and biological 

products approved under section 505 of 

the FD&C Act or section 351 of the 

Public Health Service Act. Under 

FDAAA, FDA has been given additional 

authority to require applicants to 

conduct and report on postmarketing 

studies and clinical trials to assess a 

known serious risk, assess signals of 

serious risk, or identify an unexpected 

serious risk related to the use of a 

product. This new authority became 

effective on March 25, 2008. FDA may 

now take enforcement action against 

applicants who fail to conduct studies 

and clinical trials required under 

FDAAA, as well as studies and clinical 

trials required under FDA regulations 

(see sections 505(o)(1), 502(z), and 

303(f)(4) of the FD&C Act (21 U.S.C. 

355(o)(1), 352(z), and 333(f)(4))). 

Although regulations implementing 

the Modernization Act postmarketing 

authorities use the term ‘‘postmarketing 

commitment’’ to refer to both required 


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