Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB), 71038-71039 [2011-29629]

Download as PDF 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. 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. DATES: 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. ADDRESSES: mstockstill on DSK4VPTVN1PROD with NOTICES 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] BILLING CODE 4140–01–P VerDate Mar<15>2010 17:45 Nov 15, 2011 Jkt 226001 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) 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 AGENCY: PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 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 E:\FR\FM\16NON1.SGM 16NON1 Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Notices 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. 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. SUMMARY: 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 71039 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 1 There 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] mstockstill on DSK4VPTVN1PROD with NOTICES BILLING CODE 4160–01–P VerDate Mar<15>2010 17:45 Nov 15, 2011 Jkt 226001 PO 00000 Frm 00086 Fmt 4703 Sfmt 9990 E:\FR\FM\16NON1.SGM 16NON1

Agencies

[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71038-71039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29629]


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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 tax-free 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

[[Page 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