71038 Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Notices 

Carcinogens on November 29, 2011, has 

been extended from 1–5 p.m. (EST) to 

1–7 p.m. (EST). Registration to present 

oral remarks is increased from the first 

15 to the first 23 registrants who wish 

to speak, with one time slot per 

organization. However, the total number 

of connections available for all 

registrants (including speakers plus 

observers) remains at 50. Presenters will 

speak in the order that they are 

registered. The agenda, including the 

list of speakers, will be posted on the 

NTP Web site (http://ntp.niehs.nih.gov/ 

go/rocprocess) prior to the November 

29, 2011, listening session. Information 

regarding the listening session was 

published on October 31, 2011, in the 

Federal Register (76 FR 67200) and is 

available on the NTP Web site (http:// 

ntp.niehs.nih.gov/go/rocprocess). The 

guidelines and deadlines published in 

the Federal Register notice still apply 

except as noted above. Any updates or 

additional information will be posted on 

the NTP Web site. 

DATES: The public listening session will 

be held November 29, 2011, 1–7 p.m. 

(EST). The deadline for submission of 

written comments is November 30, 

2011, and the deadline to register for the 

public listening session is November 21, 

2011. Registrants will receive 

information to access the listening 

session on or before November 22, 2011, 

and speakers should send oral 

statements and/or slides by close of 

business on November 21, 2011. 

ADDRESSES: Written public comments 

and materials from speakers for the 

listening session should be sent to Dr. 

Ruth Lunn, Director, Office of the 

Report on Carcinogens, DNTP, NIEHS, 

P.O. Box 12233, MD K2–14, Research 

Triangle Park, NC 27709; telephone: 

(919) 316–4637 or email 

lunn@niehs.nih.gov. Courier address: 

NIEHS, Room 2006, 530 Davis Drive, 

Morrisville, NC 27560. Registration for 

the listening session is via the NTP Web 

site (http://ntp.niehs.nih.gov/go/ 

rocprocess). TTY users should contact 

the Federal TTY Relay Service at (800) 

877–8330. Requests must be made at 

least 5 business days in advance of the 

listening session. 

FOR FURTHER INFORMATION CONTACT: 

Questions or comments should be 

directed to Dr. Lunn (see ADDRESSES). 

Dated: November 8, 2011. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2011–29615 Filed 11–15–11; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier: CMS–10408] 

Emergency Clearance: Public 

Information Collection Requirements 

Submitted to the Office of Management 

and Budget (OMB) 

AGENCY: Center for Medicare and 

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 and 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 functions; 

(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. 

We are, however, requesting an 

emergency review of the information 

collection referenced below. In 

compliance with the requirement of 

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

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. We 

are requesting an emergency review 

because the collection of this 

information is needed before the 

expiration of the normal time limits 

under OMB’s regulations at 5 CFR Part 

1320.13. This is necessary to ensure 

compliance with an initiative of the 

Administration. We cannot reasonably 

comply with the normal clearance 

procedures in that public harm is 

reasonably likely to result if normal 

clearance procedures are followed as 

stated in 5 CFR 1320.13(a)(2)(i). CMS’ 

use of the information collection request 

discussed in this notice is essential in 

order to comply with the requirements, 

under the Patient Protection and 

Affordable Care Act (42 U.S.C. 18002) 

and implementing regulations at 45 CFR 

part 149, that the Secretary of HHS 

develop a mechanism to monitor the 

appropriate use of funds under the Early 

Retiree Reinsurance Program. 

1. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Early Retiree 

Reinsurance Program Survey of Plan 

Sponsors; Use: Under the Patient 

Protection and Affordable Care Act (42 

U.S.C. 18002) and implementing 

regulations at 45 CFR part 149, 

employment-based plans that offer 

health coverage to early retirees and 

their spouses, surviving spouses, and 

dependents are eligible to receive taxfree reimbursement for a portion of the 

costs of health benefits provided to such 

individuals. The statute limits how the 

reimbursement funds can be used, and 

requires the Secretary of HHS to 

develop a mechanism to monitor the 

appropriate use of such funds. The 

survey that is the subject of this PRA 

package, is part of that mechanism. As 

part of the Secretary’s monitoring 

efforts, the Secretary intends to direct 

plan sponsors that have received ERRP 

funds to respond to this survey in order 

to obtain information about the ERRP 

program, including how and when plan 

sponsors have used, or intend to use, 

ERRP funds. Form Number: CMS–10408 

(OMB 0938–New); Frequency: Yearly; 

Affected Public: Private Sector: Business 

or other for-profit and not-for-profit 

institutions; Number of Respondents: 

2,076; Total Annual Responses: 2,076; 

Total Annual Hours: 22,836. (For policy 

questions regarding this collection 

contact David Mlawsky at (410) 786– 

6851. For all other issues call (410) 786– 

1326.) 

CMS is requesting OMB review and 

approval of this collection by November 

18, 2011, with a 180-day approval 

period. Written comments and 

recommendations will be considered 

from the public if received by the 

individuals designated below by 

November 16, 2011. 

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.gov/ 

PaperworkReductionActof1995/PRAL/ 

list.asp 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. 

Interested persons are invited to send 

comments regarding the burden or any 

other aspect of these collections of 

information requirements. However, as 

noted above, comments on these 

information collection and 

recordkeeping requirements must be 

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Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Notices 71039 

received via one of the following 

methods by November 16, 2011. 

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, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

3. By Email to OMB. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Email: 

OIRA_submission@omb.eop.gov. 

Dated: November 10, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–29629 Filed 11–10–11; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0555] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Extralabel Drug 

Use in Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by December 

16, 2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 

(202) 395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0325. Also 

include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Extralabel Drug Use in Animals—21 

CFR 530—(OMB Control Number 0910– 

0325)—Extension 

The Animal Medicinal Drug Use 

Clarification Act of 1994 allows a 

veterinarian to prescribe the extralabel 

use of approved new animal drugs. 

Also, it permits FDA, if it finds that 

there is a reasonable probability that the 

extralabel use of an animal drug may 

present a risk to the public health, to 

establish a safe level for a residue from 

the extralabel use of the drug, and to 

require the development of an analytical 

method for the detection of residues 

above that established safe level. 

Although to date, we have not 

established a safe level for a residue 

from the extralabel use of any new 

animal drug, and therefore, have not 

required the development of analytical 

methodology, we believe that there may 

be instances when analytical 

methodology will be required. We are 

therefore estimating the reporting 

burden based on two methods being 

required annually. The requirement to 

establish an analytical method may be 

fulfilled by any interested person. We 

believe that the sponsor of the drug will 

be willing to develop the method in 

most cases. Alternatively, FDA, the 

sponsor, and perhaps a third party may 

cooperatively arrange for method 

development. The respondents may be 

sponsors of new animal drugs, State, or 

Federal and/or State Agencies, 

academia, or individuals. 

In the Federal Register of August 16, 

2011 (76 FR 50736), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of 

respondents 

No. of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

530.22(b) .............................................................................. 2 1 2 4,160 8,320 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: November 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–29477 Filed 11–15–11; 8:45 am] 

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