Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents; Availability, 32791-32792 [2010-13922]

Download as PDF 32791 Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices MATERNAL AND CHILD HEALTH BUREAU SELECTED GRANT PROGRAMS [Extensions with funding] Grantee/organization name State Raising Special Kids ....................................................................................................................... Support for Families of Children w/Disabilities ............................................................................... Family Voices of District of Columbia, Inc. .................................................................................... Family Institute for Family Involvement .......................................................................................... Parent to Parent of Georgia, Inc. ................................................................................................... Hawaii Pediatric Association Research & Education Foundation .................................................. The Arc of Illinois ............................................................................................................................ About Special Kids, Inc. ................................................................................................................. Bayou Land Families Helping Families .......................................................................................... Federation for Children With Special Needs .................................................................................. The Parent’s Place of MD .............................................................................................................. Maine Parent Federation ................................................................................................................ Pacer Center Inc. ............................................................................................................................ University of Southern Mississippi .................................................................................................. Exceptional Children’s Assistance Center ...................................................................................... Family Voices of North Dakota, Inc ................................................................................................ PTI Nebraska .................................................................................................................................. Statewide Parent Advocacy Network of New Jersey ..................................................................... Parents Reaching Out To Help ...................................................................................................... Family TIES of Nevada, Inc ........................................................................................................... Parent to Parent of NYS ................................................................................................................. Oregon Family Support Network .................................................................................................... Parent Education & Advocacy Leadership Center ......................................................................... Rhode Island Parent Information Network, Inc. ............................................................................. South Dakota Parent Connection, Inc. ........................................................................................... Tennessee Disability Coalition ....................................................................................................... Texas Parent to Parent .................................................................................................................. Utah Parent Center ......................................................................................................................... Parent to Parent of Vermont .......................................................................................................... The Arc Wisconsin Disability Association ...................................................................................... AZ ................ CA ................ DC ................ FL ................. GA ................ HI ................. IL .................. IN ................. LA ................. MA ................ MD ............... ME ................ MN ............... MS ................ NC ................ ND ................ NE ................ NJ ................. NM ............... NV ................ NY ................ OR ................ PA ................ RI ................. SD ................ TN ................ TX ................ UT ................ VT ................ WI ................. Dated: June 3, 2010. Mary K. Wakefield, Administrator. [FR Doc. 2010–13788 Filed 6–8–10; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0277] Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents; Availability AGENCY: Food and Drug Administration, HHS. erowe on DSK5CLS3C1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents.’’ The draft guidance is intended to help small VerDate Mar<15>2010 15:10 Jun 08, 2010 Jkt 220001 entities comply with the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco in order to protect children and adolescents. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 31, 2010. ADDRESSES: The draft guidance for industry entitled ‘‘Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents’’ is available on the Internet at https:// www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatory Information/default.htm, or a paper copy may be ordered free of charge by calling 1–877–287–1373. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 FY 2009 authorized funding level $95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 95,700 Revised project end date 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. 31–May–11. found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Kathleen K. Quinn, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850–3229, 240–276– 1717, Kathleen.Quinn@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111–31; 123 Stat. 1776) was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act (FFDCA) and providing FDA with the authority to regulate tobacco products. Section 102 of the Tobacco Control Act requires FDA to publish final regulations regarding cigarettes and smokeless tobacco which are identical in their provisions to the regulations promulgated by FDA in 1996 (1996 final regulations) on August 28, 1996 (61 FR 44396), with certain specified exceptions. In the Federal Register of March 19, 2010 (75 FR 13225), FDA published its final regulations entitled ‘‘Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To E:\FR\FM\09JNN1.SGM 09JNN1 32792 Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices Protect Children and Adolescents,’’ at 21 CFR part 1140. The final regulations apply to manufacturers, distributors, and retailers who make, distribute, or sell cigarettes or smokeless tobacco products. Beginning on June 22, 2010, these Federal regulations will prohibit retailers from selling cigarettes, cigarette tobacco, or smokeless tobacco to persons under the age of 18, and will require retailers to verify the age of all customers under the age of 27 by checking a photographic identification that includes the bearer’s date of birth. FDA is announcing the availability of a draft guidance document, which is intended to help small businesses comply with the requirements of the new regulations. FDA is soliciting comments on the draft guidance document and may amend the guidance document periodically as a result of comments received. II. Significance of Guidance FDA is issuing this draft guidance document consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on ‘‘Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents.’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. erowe on DSK5CLS3C1PROD with NOTICES III. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access An electronic version of the guidance document is available on the Internet at https://www.regulations.gov and https:// www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatory Information/default.htm. VerDate Mar<15>2010 15:10 Jun 08, 2010 Jkt 220001 Dated: June 7, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–13922 Filed 6–7–10; 11:15 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Office of Public Health Support; Division of Planning, Evaluation & Research Native American Research Centers for Health (NARCH) V Evidence-Based Interventions for Tribal Communities Against AIDS and STDs Announcement Type: Competitive Supplements. Funding Announcement Number: HHS–2010–IHS–NARCH–0001. Catalog of Federal Domestic Assistance Number: 93.933. Key Dates Application Deadline Date: June 30, 2010. Review Date: July 15, 2010. Earliest Anticipated Start Date: September 1, 2010. I. Funding Opportunity Description Statutory Authority The Indian Health Service (IHS) is accepting competitive supplemental grant applications from existing Native American Research Centers for Health (NARCH) V grantees to establish and test Evidence-Based Interventions for Tribal Communities Against Acquired Immune Deficiency Syndrome (AIDS) and sexually transmitted diseases (STDs). This program is authorized under: the Snyder Act, 25 U.S.C. 13, the Public Health Service Act, 42 U.S.C. 241 as amended, and the Indian Health Care Improvement Act, 25 U.S.C. 1602(a)(b)(16). This program is described in the Catalog of Federal Domestic Assistance under 93.933. Background The NARCH V program supports partnerships between Federally recognized American Indian and Alaska Native (AI/AN) Tribes or Tribal organizations (including national and area Indian health boards, and Tribal colleges meeting the definition of a Tribal organization as defined by 25 U.S.C. 1603(d) or (e)) and institutions that conduct intensive academic-level biomedical, behavioral and health services research. These partnerships are called Native American Research Centers for Health (NARCH). Due to the PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 complexity of factors contributing to the health and disease of AI/ANs, and to their health disparities compared with other Americans, the collaborative efforts of the agencies of the Department of Health and Human Services (HHS) and the collaboration of academic researchers and AI/AN communities are needed to achieve significant improvements in the health status of AI/ AN people. To accomplish this goal, in addition to objectives set by the Tribes, Tribal organizations or Indian health boards, the IHS NARCH program pursues the following program objectives: To develop a cadre of AI/AN scientists and health professionals— Opportunities are needed to develop more AI/AN scientists and health professionals engaged in research, and to conduct biomedical, clinical, behavioral and health services research that is responsive to the needs of the AI/ AN community and the goals of this initiative. Faculty/researchers and students at each proposed NARCH develop investigator-initiated, scientifically meritorious research projects, including pilot research projects, and will be supported through science education projects designed to increase the numbers of, and to improve the research skills of, AI/AN investigators and investigators involved with AI/ANs. To enhance partnerships and reduce distrust of research by AI/AN communities—Recent community-based participatory research suggests that AI/ AN communities can work collaboratively in partnership with health researchers to further the research needs of AI/ANs. Fully utilizing all cultural and scientific knowledge, strengths, and competencies, such partnerships can lead to better understanding of the biological, genetic, behavioral, psychological, cultural, social, and economic factors either promoting or hindering improved health status of AI/ ANs, and generate the development and evaluation of interventions to improve their health status. Community distrust of research and researchers will be reduced by offering the Tribe greater control over the research process. Purpose The purpose of this opportunity for supplementing the existing NARCH V program is to determine the feasibility of adapting and implementing HIV evidence based interventions (EBI)(s) supported by the CDC for effective use within AI/AN communities, and to contribute to, and document, a successful adaption and implementation E:\FR\FM\09JNN1.SGM 09JNN1

Agencies

[Federal Register Volume 75, Number 110 (Wednesday, June 9, 2010)]
[Notices]
[Pages 32791-32792]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13922]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0277]


Draft Guidance for Industry: Compliance With Regulations 
Restricting the Sale and Distribution of Cigarettes and Smokeless 
Tobacco to Protect Children and Adolescents; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Draft Guidance 
for Industry: Compliance with Regulations Restricting the Sale and 
Distribution of Cigarettes and Smokeless Tobacco To Protect Children 
and Adolescents.'' The draft guidance is intended to help small 
entities comply with the final regulations restricting the sale and 
distribution of cigarettes and smokeless tobacco in order to protect 
children and adolescents.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 31, 2010.

ADDRESSES:  The draft guidance for industry entitled ``Draft Guidance 
for Industry: Compliance with Regulations Restricting the Sale and 
Distribution of Cigarettes and Smokeless Tobacco To Protect Children 
and Adolescents'' is available on the Internet at https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm, or 
a paper copy may be ordered free of charge by calling 1-877-287-1373.
    Submit electronic comments to https://www.regulations.gov. Submit 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Identify comments with the docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Kathleen K. Quinn, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 240-276-1717, Kathleen.Quinn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Public Law 111-31; 123 Stat. 1776) was enacted on June 
22, 2009, amending the Federal Food, Drug, and Cosmetic Act (FFDCA) and 
providing FDA with the authority to regulate tobacco products. Section 
102 of the Tobacco Control Act requires FDA to publish final 
regulations regarding cigarettes and smokeless tobacco which are 
identical in their provisions to the regulations promulgated by FDA in 
1996 (1996 final regulations) on August 28, 1996 (61 FR 44396), with 
certain specified exceptions. In the Federal Register of March 19, 2010 
(75 FR 13225), FDA published its final regulations entitled 
``Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco To

[[Page 32792]]

Protect Children and Adolescents,'' at 21 CFR part 1140. The final 
regulations apply to manufacturers, distributors, and retailers who 
make, distribute, or sell cigarettes or smokeless tobacco products.
    Beginning on June 22, 2010, these Federal regulations will prohibit 
retailers from selling cigarettes, cigarette tobacco, or smokeless 
tobacco to persons under the age of 18, and will require retailers to 
verify the age of all customers under the age of 27 by checking a 
photographic identification that includes the bearer's date of birth.
    FDA is announcing the availability of a draft guidance document, 
which is intended to help small businesses comply with the requirements 
of the new regulations. FDA is soliciting comments on the draft 
guidance document and may amend the guidance document periodically as a 
result of comments received.

II. Significance of Guidance

    FDA is issuing this draft guidance document consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the agency's current thinking on 
``Compliance with Regulations Restricting the Sale and Distribution of 
Cigarettes and Smokeless Tobacco To Protect Children and Adolescents.'' 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statute and regulations.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) either 
electronic or written comments regarding this document. It is only 
necessary to send one set of comments. It is no longer necessary to 
send two copies of mailed comments. Identify comments with the docket 
number found in brackets in the heading of this document. Received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    An electronic version of the guidance document is available on the 
Internet at https://www.regulations.gov and https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13922 Filed 6-7-10; 11:15 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.