Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug Administration Safety and Innovation Act Section 1138, 41803 [2013-16617]

Download as PDF Federal Register / Vol. 78, No. 133 / Thursday, July 11, 2013 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for July 24 and 25, 2013, is cancelled. This meeting was announced in the Federal Register of April 25, 2013 (78 FR 24426). FOR FURTHER INFORMATION CONTACT: Sara J. Anderson, Center for Devices and Radiological Health, Food and Drug Administration,10903 New Hampshire Ave., Bldg. 66, rm. 1611, Silver Spring, MD 20993, 301–796–7047, Sara.Anderson@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. SUMMARY: Dated: July 5, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–16621 Filed 7–10–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0757] Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug Administration Safety and Innovation Act Section 1138 AGENCY: Food and Drug Administration, HHS. Establishment of docket; request for comments. emcdonald on DSK67QTVN1PROD with NOTICES ACTION: The Food and Drug Administration (FDA) is announcing the establishment of a public docket for comments pertaining to the report SUMMARY: VerDate Mar<15>2010 18:23 Jul 10, 2013 Jkt 229001 mandated under the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 1138, enacted July 9, 2012, and posted on the FDA Web site on July 9, 2013. This docket is intended to solicit input on this report from all relevant stakeholders. DATES: Submit electronic or written comments by September 9, 2013. 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. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonca Bull, Office of Minority Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4274, Silver Spring, MD 20993–0002, 301–796–8000, email: jonca.bull@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On July 9, 2012, President Obama signed FDASIA (Pub. L. 112–144) into law. Section 1138 of FDASIA requires that FDA review and modify, as necessary, the FDA communication plan to inform and educate health care providers and patients on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups. Section 1138 of FDASIA requires that FDA shall publicly post the communication plan on the Internet Web site of the Office of Minority Health of FDA, and provide links to any other appropriate Internet Web site, and seek public comment on the communication plan. FDA is opening a docket for 60 days to solicit input from all relevant stakeholders regarding the communication plan and Internet links. This docket is intended to ensure that stakeholders have an opportunity to provide comments for further improvements to the plan. II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 41803 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 will be posted to the docket at https://www.regulations.gov and may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: July 5, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–16617 Filed 7–10–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Amendment to Consent Decree Under the Clean Water Act On July 5, 2013, the Department of Justice lodged a proposed amendment to a consent decree with the United States District Court for the Eastern District of Missouri in the lawsuit entitled in United States, et al. v. Metropolitan St. Louis Sewer District, Civil Action No. 4:07–CV–01120. Under the original 2012 consent decree, the Metropolitan St. Louis Sewer District (‘‘MSD’’) agreed to undertake numerous measures to come into compliance with the Clean Water Act, including constructing and implementing specific combined sewer overflow control measures. MSD still is in the process of complying with the 2012 decree. However, the proposed amendment would replace two CSO control measures (a treatment facility and a local storage facility) as required by the 2012 decree with one single CSO storage facility. The publication of this notice opens a period of public comment on the proposed amendment. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States, et al. v. Metropolitan St. Louis Sewer District, D.J. Ref. No. 90–5–1–1–08111. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: E:\FR\FM\11JYN1.SGM 11JYN1

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[Federal Register Volume 78, Number 133 (Thursday, July 11, 2013)]
[Notices]
[Page 41803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0757]


Establishment of a Public Docket for Comment on the Report 
Prepared Under the Food and Drug Administration Safety and Innovation 
Act Section 1138

AGENCY: Food and Drug Administration, HHS.

ACTION: Establishment of docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a public docket for comments pertaining to the report 
mandated under the Food and Drug Administration Safety and Innovation 
Act (FDASIA) Section 1138, enacted July 9, 2012, and posted on the FDA 
Web site on July 9, 2013. This docket is intended to solicit input on 
this report from all relevant stakeholders.

DATES: Submit electronic or written comments by September 9, 2013.

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. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonca Bull, Office of Minority Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 
4274, Silver Spring, MD 20993-0002, 301-796-8000, email: 
jonca.bull@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, President Obama signed FDASIA (Pub. L. 112-144) 
into law. Section 1138 of FDASIA requires that FDA review and modify, 
as necessary, the FDA communication plan to inform and educate health 
care providers and patients on the benefits and risks of medical 
products, with particular focus on underrepresented subpopulations, 
including racial subgroups.
    Section 1138 of FDASIA requires that FDA shall publicly post the 
communication plan on the Internet Web site of the Office of Minority 
Health of FDA, and provide links to any other appropriate Internet Web 
site, and seek public comment on the communication plan.
    FDA is opening a docket for 60 days to solicit input from all 
relevant stakeholders regarding the communication plan and Internet 
links. This docket is intended to ensure that stakeholders have an 
opportunity to provide comments for further improvements to the plan.

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 
will be posted to the docket at https://www.regulations.gov and may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: July 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16617 Filed 7-10-13; 8:45 am]
BILLING CODE 4160-01-P
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