Standards for Private Laboratory Analytical Packages and Introduction to Laboratory Related Portions of the Food Modernization Safety Act for Private Laboratory Managers, 16551-16552 [2012-6800]

Download as PDF Federal Register / Vol. 77, No. 55 / Wednesday, March 21, 2012 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9996–N3] Early Retiree Reinsurance Program Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This notice establishes a timeframe by which plan sponsors participating in the Early Retiree Reinsurance Program (ERRP) are expected to use ERRP reimbursement funds. Sponsors are expected to use such funds as soon as possible, but not later than December 31, 2014. DATES: Effective Date: This notice is effective March 16, 2012. FOR FURTHER INFORMATION CONTACT: David Mlawsky, (410) 786–6851. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background erowe on DSK2VPTVN1PROD with NOTICES The Patient Protection and Affordable Care Act (Pub. L. 111–148, enacted on March 23, 2010) (the Affordable Care Act), included a provision that established the temporary Early Retiree Reinsurance Program (ERRP) which provides reimbursement to eligible sponsors of employment-based plans for a portion of the costs of providing health coverage to early retirees (and eligible spouses, surviving spouses, and dependents of such retirees), during the period beginning on the date on which the program is established, and ending on January 1, 2014. Section 1102(a)(l) of the Affordable Care Act required the Secretary to establish the program within 90 days of enactment of the law (by June 21, 2010). In the May 5, 2010 Federal Register (75 FR 24450), we published an interim final regulation with comment period, implementing the program as of June 1, 2010. Section 1102(e) of the Affordable Care Act appropriates funding of $5 billion for the temporary program. Consistent with section 1102(c)(4) of the Affordable Care Act, the rule at 45 CFR 149.200 states: A sponsor must use the proceeds under this program to—(1) reduce the sponsor’s health benefit premiums or health benefit costs, (2) reduce health benefit premium contributions, copayments, deductibles, coinsurance, or other out-of-pocket costs, or any combination of these costs, for plan participants, or (3) reduce any combination of the costs in (a)(1) and (a)(2) of this section. Proceeds under this program must not be used as general revenue for the sponsor. VerDate Mar<15>2010 15:15 Mar 20, 2012 Jkt 226001 We have published several guidance documents that further clarify this section of the rule (see the Guidance on Complying with the Prohibition on Using Early Retiree Reinsurance Program Reimbursements as General Revenue under the Regulations and Guidance section of www.errp.gov, and the Common Questions under the Use of Reimbursement section at www.errp.gov). We have provided the available ERRP funds to reimburse plan sponsors’ eligible early retiree health care costs with the expectation that plan sponsors will use the funds in an allowable manner, as outlined in 45 CFR 149.200, as soon as possible after receiving ERRP funds. In February 2012, we released Common Question 800–13, which provided the date, December 31, 2014, by which plan sponsors are expected to use the received funds. II. Provisions of This Notice Section 1102(c)(4) of the Affordable Care Act, immediately following its discussion of how ERRP reimbursements may be used, states: ‘‘The Secretary shall develop a mechanism to monitor the appropriate use of such payments by such entities.’’ We believe that one necessary component of such a mechanism is a deadline by when plan sponsors are expected to use ERRP reimbursements. Thus, one of the Common Questions we have published to clarify the ERRP rule at 45 CFR 149.200 sets forth our expectation as to when a plan sponsor that has received ERRP reimbursement will use that reimbursement (Common Question 800–13). This notice reiterates and formalizes our expectation that a sponsor will use ERRP reimbursement funds as soon as possible, but not later than December 31, 2014. We believe this deadline is consistent with the January 1, 2014 statutory end date of the ERRP, and also affords plan sponsors the flexibility and time they may need in order to appropriately use ERRP reimbursement. Common Question 800–13 also states, and we reiterate in this notice, that a sponsor is not required to use ERRP reimbursement funds by the end of the plan year in which they are received. Sponsors may use ERRP reimbursement funds in a manner permitted under the statute, regulation, and other ERRP program guidance. III. Collection of Information Requirements This document does not impose any new information collection and recordkeeping requirements. Consequently, it need not be reviewed PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 16551 by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. However, the information collection requirements associated with the ERRP are currently approved under OMB control number 0938–1087, with an expiration date of September 30, 2014. Authority: Sections 1102(a)(l) and 1102(c)(4) of the Affordable Care Act (42 U.S.C. 18002(a)(l) and(c)(4)). Dated: March 13, 2012. Marilyn Tavenner, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2012–6728 Filed 3–16–12; 11:15 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Standards for Private Laboratory Analytical Packages and Introduction to Laboratory Related Portions of the Food Modernization Safety Act for Private Laboratory Managers AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meetings. The Food and Drug Administration (FDA) is announcing two meetings entitled ‘‘Standards for Private Laboratory Analytical Packages and Introduction to Laboratory Related Portions of the Food Modernization Safety Act for Private Laboratory Managers.’’ The topic to be discussed is the quality standards expected in all analytical packages and an introduction to sections of the Food Safety Modernization Act of January 6, 2011, that affect laboratories. Date and Time: The meetings will be held on April 3, 2012, from 1 p.m. to 4:30 p.m. in Bothell, WA, and on April 5, 2012, from 1 p.m. to 4:30 p.m. in Oakland, CA. Location: The meeting in Bothell, WA, will be held at the FDA Seattle District Office, 22201 23rd Dr. SE., Bothell, WA 98021. The Oakland, CA, meeting will be held in the R. Dellums Federal Building, Conference Room A/B, 2nd Floor North, 1301 Clay St., Oakland, CA 94612. Contact: R.V. Asmundson, Food and Drug Administration, 1301 Clay St., Suite 1180N, Oakland, CA 94612–5217, 510–287–2715, FAX: 510–287–3739, email: rod.asmundson@fda.hhs.gov. Registration: Send registration information (including name, title, firm E:\FR\FM\21MRN1.SGM 21MRN1 16552 Federal Register / Vol. 77, No. 55 / Wednesday, March 21, 2012 / Notices name, address, telephone, FAX, and email) to the contact person by March 27, 2012. If you need special accommodations due to a disability, please contact Nguyen Ngoc-Lan (nguyen.ngoclan@fda.hhs.gov) for the Bothell, WA, meeting or Bernadette Thiry (bthiry@mmcor.com) for the Oakland, CA, meeting by March 27, 2012. Dated: March 16, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–6800 Filed 3–20–12; 8:45 am] BILLING CODE 4160–01–P the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to oira_submission@omb.eop.gov or faxed to (202) 395–6974. FOR FURTHER INFORMATION CONTACT: Joanna Johnson, TSA PRA Officer, Office of Information Technology (OIT), TSA–11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598–6011; telephone (571) 227–3651; email TSAPRA@dhs.gov. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HOMELAND SECURITY Comments Invited Transportation Security Administration [Docket No. TSA–2005–20118] Extension of Agency Information Collection Activity Under OMB Review: Maryland-Three Airports: Enhanced Security Procedures at Certain Airports in the Washington, DC, Area Transportation Security Administration, DHS. ACTION: 30-Day notice. AGENCY: This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652–0029, abstracted below to OMB for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. TSA published a Federal Register notice, with a 60-day comment period soliciting comments, of the following collection of information on January 5, 2012, 77 FR 513. This collection requires individuals to submit information that will allow TSA to conduct a terrorist threat assessment that could allow a pilot to operate an aircraft to, from, or between the three Maryland airports that are located within the Washington, DC, Metropolitan Area Flight Restricted Zone (Maryland-Three airports), or allow an individual to serve as an airport security coordinator at one of these three airports. DATES: Send your comments by April 20, 2012. A comment to OMB is most effective if OMB receives it within 30 days of publication. ADDRESSES: Interested persons are invited to submit written comments on erowe on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:15 Mar 20, 2012 Jkt 226001 In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The ICR documentation is available at https://www.reginfo.gov. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to— (1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Information Collection Requirement Title: Maryland-Three Airports: Enhanced Security Procedures at Certain Airports in the Washington, DC, Area. Type of Request: Extension of a currently approved collection. OMB Control Number: 1652–0029. Form(s): Personal Identification Number Issuance Form. Affected Public: Maryland-Three airports and individuals who seek to operate an aircraft to or from one of the three Maryland airports, or to serve as an airport security coordinator at one of these three airports. Abstract: Part 1562 of 49 CFR sets forth security measures that permit flight operations at the Maryland-Three PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 airports (College Park Airport, Potomac Airfield, and Washington Executive/ Hyde Field). TSA requires applicants seeking to fly to, from, or between the Maryland-Three airports, or seeking to serve as security coordinators in one of these airports, to submit personal information and fingerprints. TSA will use the applicant’s information and fingerprints to conduct a security threat assessment. An applicant will not receive TSA’s approval to fly to, from, or between the Maryland-Three airports, or to serve as a security coordinator in one of these airports, if the applicant does not successfully complete the security threat assessment. Number of Respondents: 312. Estimated Annual Burden Hours: An estimated 6,473 hours annually. Issued in Arlington, Virginia, on March 15, 2012. Joanna Johnson, TSA Paperwork Reduction Act Officer, Office of Information Technology. [FR Doc. 2012–6738 Filed 3–20–12; 8:45 am] BILLING CODE 9110–05–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Agency Information Collection Activities: JADE Act U.S. Customs and Border Protection, Department of Homeland Security. ACTION: 30-Day notice and request for comments; Extension of an existing information collection: 1651–0133. AGENCY: U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: JADE Act. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments from the public and affected agencies. This information collection was previously published in the Federal Register (77 FR 1947) on January 12, 2012, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10. DATES: Written comments should be received on or before April 20, 2012. SUMMARY: E:\FR\FM\21MRN1.SGM 21MRN1

Agencies

[Federal Register Volume 77, Number 55 (Wednesday, March 21, 2012)]
[Notices]
[Pages 16551-16552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Standards for Private Laboratory Analytical Packages and 
Introduction to Laboratory Related Portions of the Food Modernization 
Safety Act for Private Laboratory Managers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meetings.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing two meetings 
entitled ``Standards for Private Laboratory Analytical Packages and 
Introduction to Laboratory Related Portions of the Food Modernization 
Safety Act for Private Laboratory Managers.'' The topic to be discussed 
is the quality standards expected in all analytical packages and an 
introduction to sections of the Food Safety Modernization Act of 
January 6, 2011, that affect laboratories.
    Date and Time: The meetings will be held on April 3, 2012, from 1 
p.m. to 4:30 p.m. in Bothell, WA, and on April 5, 2012, from 1 p.m. to 
4:30 p.m. in Oakland, CA.
    Location: The meeting in Bothell, WA, will be held at the FDA 
Seattle District Office, 22201 23rd Dr. SE., Bothell, WA 98021. The 
Oakland, CA, meeting will be held in the R. Dellums Federal Building, 
Conference Room A/B, 2nd Floor North, 1301 Clay St., Oakland, CA 94612.
    Contact: R.V. Asmundson, Food and Drug Administration, 1301 Clay 
St., Suite 1180N, Oakland, CA 94612-5217, 510-287-2715, FAX: 510-287-
3739, email: rod.asmundson@fda.hhs.gov. Registration: Send registration 
information (including name, title, firm

[[Page 16552]]

name, address, telephone, FAX, and email) to the contact person by 
March 27, 2012.
    If you need special accommodations due to a disability, please 
contact Nguyen Ngoc-Lan (nguyen.ngoc-lan@fda.hhs.gov) for the Bothell, 
WA, meeting or Bernadette Thiry (bthiry@mmcor.com) for the Oakland, CA, 
meeting by March 27, 2012.

    Dated: March 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6800 Filed 3-20-12; 8:45 am]
BILLING CODE 4160-01-P
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