Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Notices 37813 

Information provides funding to EPA’s 

Exchange Network partners (states, 

territories, and Federally recognized 

Indian Tribes) to support the 

development of the NEIEN. The NEIEN 

is an Internet and- standards-based, 

secure information system that supports 

the electronic collection, exchange, and 

integration of data among its partners. 

Funding for the Grant Program has been 

provided through annual congressional 

appropriations for the EPA. 

To enhance the quality and overall 

public benefit of the Network, EPA 

proposes to collect information from the 

NEIEN grantees about how they intend 

to ensure quality in their projects and 

the environmental outcomes and 

outputs from their projects. The 

proposed Quality Assurance Reporting 

Form is intended to provide a simple 

means for grant recipients to describe 

how quality will be addressed 

throughout their projects. The Quality 

Assurance Reporting Form is derived 

from guidelines provided in the NEIEN 

2006 grant solicitation notice. As a 

stipulation of their award, grant 

recipients are to submit the form within 

ninety days of grant award. 

Grantees are currently required to 

submit semi-annual progress reports as 

a stipulation of their award. In these 

reports, grantees outline project goals, 

activities required to meet these goals, 

and outputs and outcomes of activities 

to date. At the request of numerous 

grantees, we are proposing to offer the 

Progress Reporting Form as a vehicle for 

collecting information. This form is 

easier to complete than an unstructured 

narrative; it can be used as the semiannual and final report form and the 

information returned will be of higher 

quality and comparable. 

Burden Statement: The annual public 

reporting and recordkeeping burden for 

this collection of information is 

estimated to average 1.5 hours for the 

Semi-Annual Report Form per response 

and 1 hour per Quality Assurance Form 

per response. Burden means the total 

time, effort, or financial resources 

expended by persons to generate, 

maintain, retain, or disclose or provide 

information to or for a Federal agency. 

This includes the time needed to review 

instructions; develop, acquire, install, 

and utilize technology and systems for 

the purposes of collecting, validating, 

and verifying information, processing 

and maintaining information, and 

disclosing and providing information; 

adjust the existing ways to comply with 

any previously applicable instructions 

and requirements that have 

subsequently changed; train personnel 

to be able to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

Respondents/Affected Entities: State, 

Tribal, and Territorial Environmental 

Offices receiving NEIEN grants. 

Estimated Number of Respondents: 

225. Frequency of Response: Twice for 

the Semi-Annual Report Form; once for 

the Quality Assurance Form. 

Estimated Total Annual Hour Burden: 

733. Estimated Total Annual Cost: 

$37,000 includes $0 annualized capital 

or O&M costs and $37,000 annual labor 

costs. 

Are there changes in the estimates from 

the last approval? 

Changes in the Estimates: There is no 

change in estimate from the last ICR 

renewal. 

What is the next step in the process for 

this ICR? 

EPA will consider the comments 

received and amend the ICR as 

appropriate. The final ICR package will 

then be submitted to OMB for review 

and approval pursuant to 5 CFR 

1320.12. At that time, EPA will issue 

another Federal Register notice 

pursuant to 5 CFR 1320.5(a)(1)(iv) to 

announce the submission of the ICR to 

OMB and the opportunity to submit 

additional comments to OMB. If you 

have any questions about this ICR or the 

approval process, please contact the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

Dated: June 22, 2011. 

Jeffrey Wells, 

Acting Director, Information Exchange & 

Services Division. 

[FR Doc. 2011–16194 Filed 6–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10321] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Early Retiree 

Reinsurance Program (ERRP); Use: 

Under section 1102 of the Affordable 

Care Act and implementing regulations 

at 45 CFR part 149, employment-based 

plans that offer health benefits to early 

retirees and their spouses, surviving 

spouses and dependents are eligible 

under a temporary program to receive a 

tax-free reimbursement for the costs of 

certain health benefits for such 

individuals (the Early Retiree 

Reinsurance Program, or ERRP). In order 

to qualify, plan sponsors must submit a 

complete application to the U.S. 

Department of Health & Human Services 

(HHS). In order to receive 

reimbursement under the program, they 

must also submit documentation of 

actual costs for health care benefits, 

which consists of documentation of 

actual costs for the items and services 

involved, and a list of individuals to 

whom the documentation applies. Once 

HHS reviews and analyzes the 

information on the application, 

notification will be sent to the plan 

sponsor about its eligibility to 

participate in the program. Once HHS 

reviews and analyzes each 

reimbursement request, reimbursement 

under the program will be made to the 

sponsor, as appropriate. The program’s 

funding is limited to $5 billion, and the 

program sunsets on January 1, 2014. 

As compared with the burden 

estimates OMB approved on December 

22, 2010, for OMB #0938–1087. There is 

a nominal change to burden of 1 hour, 

to account for the fact that sponsors 

have an obligation to update any 

incorrect or outdated information in 

their applications. Beyond that, there is 

no change to burden. The burden hours 

associated with reading the guidance 

materials related to disclosing data 

inaccuracies that are being included 

with this revised PRA submission, and 

with completing the Prima Facie 

Evidence Cover Sheet that is being 

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37814 Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Notices 

included with this revised PRA 

submission, were already accounted for 

in the PRA package OMB approved on 

December 22, 2010. Specially, the 

burden associated with completing the 

Prima Facie Evidence cover sheet, was 

included in the burden estimate for 

submitting a reimbursement request. 

The burden associated with reading the 

guidance paper on reporting data 

inaccuracies was already included in 

the burden estimate for disclosing data 

inaccuracies. Form Number: CMS– 

10321 (OCN: 0938–1087); Frequency: 

Occasionally; Affected Public: Private 

Sector: Business or other for-profits and 

Not-for-profit institutions: State, Local, 

or Tribal Governments; Number of 

Respondents: 13,200; Number of 

Responses; 71,330; Total Annual Hours: 

1,927,575. (For policy questions 

regarding this collection, contact Dave 

Mlawsky at (410) 786–6851. 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on July 28, 2011. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: June 23, 2011. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2011–16233 Filed 6–24–11; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0481] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; New Animal Drugs 

for Investigational Uses 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the reporting and recordkeeping 

requirements for ‘‘New Animal Drugs 

for Investigational Uses.’’ 

DATES: Submit electronic or written 

comments on the collection of 

information by August 29, 2011. 

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: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

Juanmanuel.vilela@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, 

including each proposed extension of an 

existing 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 

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. 

New Animal Drugs for Investigational 

Uses—21 CFR Part 511 (OMB Control 

Number 0910–0117—Extension) 

FDA has the authority under the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) to approve new animal 

drugs. Section 512(j) of the FD&C Act 

(21 U.S.C. 360b(j)) authorizes FDA to 

issue regulations relating to the 

investigational use of new animal drugs. 

The regulations setting forth the 

conditions for investigational use of 

new animal drugs have been codified at 

part 511 (21 CFR part 511). If the new 

animal drug is only for tests in vitro or 

in laboratory research animals, the 

person distributing the new animal drug 

must maintain records showing the 

name and post office address of the 

expert or expert organization to whom 

it is shipped and the date, quantity, and 

batch or code mark of each shipment 

and delivery for a period of 2 years after 

such shipment or delivery. Before 

shipping a new animal drug for clinical 

investigations in animals, a sponsor 

must submit to FDA a Notice of Claimed 

Investigational Exemption (NCIE). The 

NCIE must contain, among other things, 

the following specific information: (1) 

Identity of the new animal drug, (2) 

labeling, (3) statement of compliance of 

any non-clinical laboratory studies with 

good laboratory practices, (4) name and 

address of each clinical investigator, (5) 

the approximate number of animals to 

be treated or amount of new animal 

drug(s) to be shipped, and (6) 

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