Notice of Availability of Final Policy Document, 12553-12554 [2010-5671]

Download as PDF 12553 Federal Register / Vol. 75, No. 50 / Tuesday, March 16, 2010 / Notices required to appear in advertising and packaging. FDA is required to review each plan submitted and approve the plan if it provides for rotation, display, and distribution of warnings in compliance with the requirements of the Smokeless Tobacco Act. To the best of FDA’s knowledge, all of the affected companies have previously submitted similar plans to the Federal Trade Commission (FTC), which had authority to implement the requirements of the Smokeless Tobacco Act prior to the Tobacco Control Act’s amendments. However, since the requirements of the Smokeless Tobacco Act have been revised and since FDA now has authority to implement the Smokeless Tobacco Act, each affected company will be required to submit a new plan to FDA instead of FTC. The Tobacco Control Act’s amendments to the Smokeless Tobacco Act are effective on June 22, 2010. In the Federal Register of August 7, 2007 (72 FR 44138), FTC published a 30-day notice announcing an opportunity for public comment and that the information collection would be sent to OMB for review. Based on FTC’s previous experience with the submission of rotational plans and FDA’s experience with smokeless tobacco companies (e.g., correspondence associated with user fees under section 919 of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act), FDA estimates that there are 14 companies affected by this information collection. To account for the entry of new smokeless tobacco companies who may be affected by this information collection, FDA is estimating the total number of respondents to be 20. When FTC originally implemented the rotational plan requirements in 1986, the Smokeless Tobacco Council, Inc. indicated that the 6 companies it represented would require 700 to 800 hours in total (133 hours each) to complete an initial rotational plan, involving multiple brands, multiple brand varieties, and multiple forms of both packaging and advertising. When FTC requested an extension of their PRA clearance in 2007, FTC decreased the estimate for submitting an initial plan from 143 hours to 60 hours, accounting for increased computerization and improvements in electronic communication over the subsequent 20 years since the Smokeless Tobacco Act was enacted. FDA believes the estimate of 60 hours to complete an initial rotational plan continues to be reasonable. However, since the requirements of the new Smokeless Tobacco Act are unfamiliar to industry, FDA is increasing the time estimate for submitting initial plans to 100 hours. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Activity Submission of rotational plans for health warning label statements 1 There 20 Total Annual Responses 1 Hours per Response 20 Total Hours 100 2,000 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 11, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. and/or for Federally Qualified Health Center Look-Alike designation. The PIN, ‘‘Confirming Public Agency Status under the Health Center Program and FQHC Look-Alike Program,’’ and the Agency’s ‘‘Response to Public Comments’’ are available on the Internet at http:// bphc.hrsa.gov/policy/pin1001/and http://bphc.hrsa.gov/policy/pin1001/ PublcCommentsPIN2010–01.pdf, respectively. [FR Doc. 2010–5654 Filed 3–15–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Final Policy Document AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Final agency guidance and response to public comments. sroberts on DSKD5P82C1PROD with NOTICES Annual Frequency per Response SUMMARY: HRSA is publishing a Final Agency Guidance (‘‘Policy Information Notice’’ (PIN) 2010–01) to describe the documentation that will be considered by the Health Resources and Services Administration (HRSA) in confirming public agency status for organizations that self-identify as public agencies (also referred to in previous PINs as ‘‘public entities’’ or ‘‘public applicants’’) for Health Center Program grant funding authorized under section 330 of the Public Health Service Act, as amended, VerDate Nov<24>2008 16:33 Mar 15, 2010 Jkt 220001 DATES: The effective date of this final Agency guidance is February 5, 2010. Background: HRSA administers the Health Center Program, which supports more than 1,100 organizations operating more than 7,500 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve medically underserved communities delivering preventive and primary care services to patients regardless of their ability to pay. The Health Center Program’s authorizing statute and implementing regulations (Section 330 of the PHS Act, as amended, 42 CFR part 51c, and 42 CFR part 56) state that any public or non-profit private entity is eligible to apply for a grant under the Health PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Center Program. The term ‘‘public agency’’ is not defined in section 330 of the PHS Act, as amended, or in the Health Center Program’s regulations; however, reference is made to public agencies in section 330 of the PHS Act, as amended, in the context of defining a public center as ‘‘a health center funded (or to be funded) through a grant under this section to a public agency.’’ (Sentence following Section 330(k)(3)(M) of the PHS Act, as amended) HRSA is issuing this PIN to describe the documentation that will be considered by HRSA in confirming public agency status for organizations that self-identify as public agencies (also referred to in previous PINs as ‘‘public entities’’ or ‘‘public applicants’’) for Health Center Program grant funding authorized under section 330 of the Public Health Service Act, as amended, and/or for Federally Qualified Health Center Look-Alike designation. On August 14, 2009, the Health Resources and Services Administration (HRSA) made the draft Program Information Notice (PIN), ‘‘Confirming Public Agency Status under the Health Center Program and FQHC Look-Alike Program,’’ available for public comment. HRSA also published a notice in the E:\FR\FM\16MRN1.SGM 16MRN1 12554 Federal Register / Vol. 75, No. 50 / Tuesday, March 16, 2010 / Notices Federal Register of August 28, 2009, requesting comments on this draft PIN. Sixteen parties, including both individuals and groups, submitted a total of 31 comments regarding the draft PIN. After review and careful consideration of all comments received, HRSA has amended the PIN to incorporate certain recommendations from the public. The final PIN reflects these changes. In addition to making the final PIN available on HRSA’s Web site, HRSA is also posting the Agency’s ‘‘Response to Public Comments.’’ The purpose of that document is to summarize the major comments received and describe the Agency’s response, including any corresponding changes made to the PIN. Where comments did not result in a revision to the PIN, explanations are provided. FOR FURTHER INFORMATION CONTACT: For questions regarding this notice, please contact the Office of Policy and Program Development, Bureau of Primary Health Care, HRSA, at OPPDGeneral@hrsa.gov. Dated: March 8, 2010. Mary K. Wakefield, Administrator. [FR Doc. 2010–5671 Filed 3–15–10; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention sroberts on DSKD5P82C1PROD with NOTICES Clinical Laboratory Improvement Advisory Committee: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92– 463) of October 6, 1972, that the Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through February 19, 2012. For information, contact Thomas Hearn, PhD, Designated Federal Officer, Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention, Department of Health and Human Services, 1600 Clifton Road, NE., Mailstop C12, Atlanta, Georgia 30333, telephone (404) 718–1048 or fax (404) 639–3039. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the CDC VerDate Nov<24>2008 16:33 Mar 15, 2010 Jkt 220001 and the Agency for Toxic Substances and Disease Registry. Dated: March 9, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. Dated: March 9, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2010–5628 Filed 3–15–10; 8:45 am] BILLING CODE 4163–18–P [FR Doc. 2010–5633 Filed 3–15–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Centers for Disease Control and Prevention National Advisory Council on Nurse Education and Practice; Notice of Meeting Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92–463), notice is hereby given of the following meetings: Name: National Advisory Council on Nurse Education and Practice (NACNEP). Dates and Times: April 22, 2010, 8:30 a.m.–4:30 p.m. April 23, 2010, 8:30 a.m.–4 p.m. Place: Doubletree Bethesda Hotel & Executive Meeting Center, 8120 Wisconsin Avenue, Bethesda, MD 20814. Status: The meeting will be open to the public. Agenda: Agency and Bureau administrative updates will be provided. Purpose: The purpose of this meeting is to address issues relating to the role of nursing in primary care and implications for workforce. The objectives of the meeting are to: (1) Delineate the variety of roles nurses play in primary care including health promotion, screening, public education, illness prevention, primary care and management of stable chronic conditions; (2) review and evaluate the data related to education preparation and supply of primary care nurses and advanced practice registered nurses; (3) describe factors that facilitate and sustain primary care practice by qualified, competent advanced practice registered nurses; (4) identify the financial and regulatory barriers to effective, accessible primary care delivered by nurses and recommended strategies for resolution; and (5) review and recommend community-based, nurse-directed models for primary care delivery that are cost effective and produce quality outcomes. This meeting is a continuation of the meeting that was held November 2009. Experts from professional nursing, public and private organizations will make presentations on primary care delivery models. During this meeting, the NACNEP council In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting for the aforementioned committee: Time and Date: 8:15 a.m.–5 p.m., March 30, 2010; 8 a.m.–11:30 a.m., March 31, 2010. Place: Hilton Garden Inn Pittsburgh/ Southpointe, 1000 Corporate Drive, Canonsburg, Pennsylvania 15317, telephone (724) 743–5000, fax (724) 743–5010. Status: Open to public, limited only by the space available. The meeting room accommodates approximately 50 people. Purpose: This committee is charged with providing advice to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NIOSH, on priorities in mine safety and health research, including grants and contracts for such research, 30 U.S.C. 812(b)(2), Section 102(b)(2). Matters To Be Discussed: The meeting will focus on deep cover retreat mining research, mine illumination research, mine escape and rescue, human factors research, coal dust particle size surveys, and updates on proximity detection, a mine escape vehicle, robotics research, and results of broad agency announcements for mining research. Agenda items are subject to change as priorities dictate. For More Information Contact: Jeffery L. Kohler, PhD, Designated Federal Officer, MSHRAC, NIOSH, CDC, 626 Cochrans Mill Road, telephone (412) 386–5301, fax (412) 386–5300. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 75, Number 50 (Tuesday, March 16, 2010)]
[Notices]
[Pages 12553-12554]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Notice of Availability of Final Policy Document

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Final agency guidance and response to public comments.

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SUMMARY: HRSA is publishing a Final Agency Guidance (``Policy 
Information Notice'' (PIN) 2010-01) to describe the documentation that 
will be considered by the Health Resources and Services Administration 
(HRSA) in confirming public agency status for organizations that self-
identify as public agencies (also referred to in previous PINs as 
``public entities'' or ``public applicants'') for Health Center Program 
grant funding authorized under section 330 of the Public Health Service 
Act, as amended, and/or for Federally Qualified Health Center Look-
Alike designation. The PIN, ``Confirming Public Agency Status under the 
Health Center Program and FQHC Look-Alike Program,'' and the Agency's 
``Response to Public Comments'' are available on the Internet at http:/
/bphc.hrsa.gov/policy/pin1001/and http://bphc.hrsa.gov/policy/pin1001/PublcCommentsPIN2010-01.pdf, respectively.

DATES: The effective date of this final Agency guidance is February 5, 
2010.
    Background: HRSA administers the Health Center Program, which 
supports more than 1,100 organizations operating more than 7,500 health 
care delivery sites, including community health centers, migrant health 
centers, health care for the homeless centers, and public housing 
primary care centers. Health centers serve medically underserved 
communities delivering preventive and primary care services to patients 
regardless of their ability to pay. The Health Center Program's 
authorizing statute and implementing regulations (Section 330 of the 
PHS Act, as amended, 42 CFR part 51c, and 42 CFR part 56) state that 
any public or non-profit private entity is eligible to apply for a 
grant under the Health Center Program. The term ``public agency'' is 
not defined in section 330 of the PHS Act, as amended, or in the Health 
Center Program's regulations; however, reference is made to public 
agencies in section 330 of the PHS Act, as amended, in the context of 
defining a public center as ``a health center funded (or to be funded) 
through a grant under this section to a public agency.'' (Sentence 
following Section 330(k)(3)(M) of the PHS Act, as amended) HRSA is 
issuing this PIN to describe the documentation that will be considered 
by HRSA in confirming public agency status for organizations that self-
identify as public agencies (also referred to in previous PINs as 
``public entities'' or ``public applicants'') for Health Center Program 
grant funding authorized under section 330 of the Public Health Service 
Act, as amended, and/or for Federally Qualified Health Center Look-
Alike designation.
    On August 14, 2009, the Health Resources and Services 
Administration (HRSA) made the draft Program Information Notice (PIN), 
``Confirming Public Agency Status under the Health Center Program and 
FQHC Look-Alike Program,'' available for public comment. HRSA also 
published a notice in the

[[Page 12554]]

Federal Register of August 28, 2009, requesting comments on this draft 
PIN.
    Sixteen parties, including both individuals and groups, submitted a 
total of 31 comments regarding the draft PIN. After review and careful 
consideration of all comments received, HRSA has amended the PIN to 
incorporate certain recommendations from the public. The final PIN 
reflects these changes.
    In addition to making the final PIN available on HRSA's Web site, 
HRSA is also posting the Agency's ``Response to Public Comments.'' The 
purpose of that document is to summarize the major comments received 
and describe the Agency's response, including any corresponding changes 
made to the PIN. Where comments did not result in a revision to the 
PIN, explanations are provided.

FOR FURTHER INFORMATION CONTACT: For questions regarding this notice, 
please contact the Office of Policy and Program Development, Bureau of 
Primary Health Care, HRSA, at OPPDGeneral@hrsa.gov.

    Dated: March 8, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010-5671 Filed 3-15-10; 8:45 am]
BILLING CODE 4165-15-P