Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease; Availability, 9396-9397 [2013-02863]

Download as PDF 9396 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices Dated: February 4, 2013. Leslie Kux, Assistant Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1–877–287–1373, gerie.voss@fda.hhs.gov. SUPPLEMENTARY INFORMATION: [FR Doc. 2013–02858 Filed 2–7–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2012–D–1083] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.’’ This draft guidance provides responses to questions FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) relating to tobacco products in retail outlets. This draft guidance is not final nor is it in effect at this time. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft by April 9, 2013. ADDRESSES: Submit written requests for single copies of the guidance entitled ‘‘Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions’’ to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850–3229. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance 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. sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:23 Feb 07, 2013 Jkt 229001 Dated: February 4, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–02861 Filed 2–7–13; 8:45 am] BILLING CODE 4160–01–P I. Background Food and Drug Administration AGENCY: Products/GuidanceCompliance RegulatoryInformation/default.htm. This draft guidance provides responses to questions FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the FD&C Act relating to tobacco products in retail outlets. In this draft guidance, FDA provides responses to questions relating to civil money penalties for violations of the requirement that tobacco products may not be sold or distributed in violation of FDA’s ‘‘Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents’’ (75 FR 13225, March 19, 2010, codified at 21 CFR part 1140). This draft guidance also provides additional information regarding the complaint procedure used for civil money penalties. II. Significance of Guidance This draft guidance is being issued 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 ‘‘Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.’’ 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 Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. It is only necessary to send one set of 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, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access An electronic version of the draft guidance document is available on the Internet at https://www.regulations.gov and https://www.fda.gov/Tobacco PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0077] Draft Guidance for Industry on Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease.’’ This guidance outlines FDA’s current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer’s disease that occur before the onset of overt dementia. 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 April 9, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance 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. FOR FURTHER INFORMATION CONTACT: Nicholas A. Kozauer, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4351, SUMMARY: E:\FR\FM\08FEN1.SGM 08FEN1 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease.’’ This guidance outlines FDA’s current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer’s disease (AD) that occur before the onset of overt dementia. Specifically, this guidance addresses FDA’s current thinking regarding the selection of patients with early AD, or who are determined to be at risk of developing AD, for enrollment into clinical trials. The selection of outcome measures for trials in these populations that are designed to demonstrate a clinical benefit, as well as the manner in which disease modification might be demonstrated, are also addressed. The design of clinical trials that are specifically focused on the treatment of patients with established Alzheimer’s disease dementia (i.e., dementia of the Alzheimer’s type), or any of the autosomal dominant forms of AD, are not explicitly discussed although many of the principles in this guidance will be pertinent. This draft guidance is being issued 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 developing drugs for the treatment of early Alzheimer’s disease. 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 statutes and regulations. sroberts on DSK5SPTVN1PROD with NOTICES Silver Spring, MD 20993–0002, 301– 796–2250. SUPPLEMENTARY INFORMATION: Dated: February 5, 2013. Leslie Kux, Assistant Commissioner for Policy. II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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, and will be posted to the docket at https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance VerDate Mar<15>2010 17:23 Feb 07, 2013 Jkt 229001 [FR Doc. 2013–02863 Filed 2–7–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0448] International Drug Scheduling; Convention on Psychotropic Substances; World Health Organization Scheduling Recommendations for Gammahydroxybutyric Acid AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice and/or public meeting will be considered in preparing the U.S. position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2013. This notice is issued under the Controlled Substances Act (the CSA). DATES: Submit either electronic or written comments by February 25, 2013. Submit requests for a public meeting on or before February 19, 2013. (For additional information, see also section IV of this document). ADDRESSES: 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. FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug Evaluation and Research, Controlled Substance Staff, Food and Drug Administration, Bldg. 51, rm. 5150, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3156, email: james.hunter@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 9397 I. Background The United States is a party to the 1971 Convention on Psychotropic Substances (the Convention). Section 201(d)(2)(B) of the CSA (21 U.S.C. 811(d)(2)(B)) provides that when the United States is notified under Article 2 of the Convention that CND proposes to decide whether to add a drug or other substance to one of the schedules of the Convention, transfer a drug or substance from one schedule to another, or delete it from the schedules, the Secretary of State must transmit notice of such information to the Secretary of Health and Human Services (Secretary of HHS). The Secretary of HHS must then publish a summary of such information in the Federal Register and provide opportunity for interested persons to submit comments. The Secretary of HHS must then evaluate the proposal and furnish a recommendation to the Secretary of State that shall be binding on the representative of the United States in discussions and negotiations relating to the proposal. As detailed in the following paragraphs, the Secretary of State has received one notification from the Secretary-General of the United Nations (the Secretary-General) regarding substances to be considered for control under the Convention. This notification reflects the recommendation from the 35th WHO Expert Committee for Drug Dependence (ECDD), which met in June 2012. In the Federal Register of September 05, 2008 (73 FR 51823), FDA announced the WHO ECDD review and invited interested persons to submit information for WHO’s consideration. The full text of the notification from the Secretary-General is provided in section II of this document. Section 201(d)(2)(B) of the CSA requires the Secretary of HHS, after receiving a notification proposing scheduling, to publish a notice in the Federal Register to provide the opportunity for interested persons to submit information and comments on the proposed scheduling action. II. United Nations Notification The formal United Nations notification that identifies the drug substance and explains the basis for the recommendations is reproduced as follows: Reference: NAR/CL.6/2012 WHO/ECDD35 1971C–Art.2 CU 2012/196/DTA/SGB The Secretary-General of the United Nations presents his compliments to the Secretary of State of the United States of America and has the honour to inform the Government that the Director- E:\FR\FM\08FEN1.SGM 08FEN1

Agencies

[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Notices]
[Pages 9396-9397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02863]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0077]

Draft Guidance for Industry on Alzheimer's Disease: Developing
Drugs for the Treatment of Early Stage Disease; 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 ``Alzheimer's
Disease: Developing Drugs for the Treatment of Early Stage Disease.''
This guidance outlines FDA's current thinking as to how a sponsor could
demonstrate efficacy in clinical trials in patients in the early stages
of Alzheimer's disease that occur before the onset of overt dementia.

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 April 9, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance 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.

FOR FURTHER INFORMATION CONTACT: Nicholas A. Kozauer, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4351,

[[Page 9397]]

Silver Spring, MD 20993-0002, 301-796-2250.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of
Early Stage Disease.'' This guidance outlines FDA's current thinking as
to how a sponsor could demonstrate efficacy in clinical trials in
patients in the early stages of Alzheimer's disease (AD) that occur
before the onset of overt dementia. Specifically, this guidance
addresses FDA's current thinking regarding the selection of patients
with early AD, or who are determined to be at risk of developing AD,
for enrollment into clinical trials. The selection of outcome measures
for trials in these populations that are designed to demonstrate a
clinical benefit, as well as the manner in which disease modification
might be demonstrated, are also addressed. The design of clinical
trials that are specifically focused on the treatment of patients with
established Alzheimer's disease dementia (i.e., dementia of the
Alzheimer's type), or any of the autosomal dominant forms of AD, are
not explicitly discussed although many of the principles in this
guidance will be pertinent.
This draft guidance is being issued 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 developing
drugs for the treatment of early Alzheimer's disease. 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 statutes and
regulations.

II. Comments

Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at https://www.regulations.gov.

III. Electronic Access

Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

Dated: February 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02863 Filed 2-7-13; 8:45 am]
BILLING CODE 4160-01-P

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