Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2010 Proposed Guidance Development, 53754-53755 [E9-25179]

Download as PDF 53754 Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 201 have been approved under OMB Control No. 0910–0572; 21 CFR part 211 have been approved under OMB Control No. 0910–0139; 21 CFR part 600 have been approved under OMB Control No. 0910–0308; 21 CFR parts 601, 610, and FDA Form 356(h) have been approved under OMB Control No. 0910–0338; 21 CFR part 1271 have been approved under OMB Control Nos. 0910–0559, 0910–0469, and 0910–0543; and FDA Form 3500A has been approved under OMB Control No. 0910– 0291. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments regarding the guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. Dated: October 14, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–25135 Filed 10–19–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration cprice-sewell on DSKGBLS3C1PROD with NOTICES [Docket No. FDA–2007–N–0270] Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2010 Proposed Guidance Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the VerDate Nov<24>2008 14:46 Oct 19, 2009 Jkt 220001 Web location where it will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances. DATES: Submit written or electronic comments at any time. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. WO66, rm. 4436, Silver Spring, MD 20993, 301–796–5739. SUPPLEMENTARY INFORMATION: I. Background During negotiations over the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA), FDA agreed, in return for additional funding from industry, to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly. These commitments include annually posting a list of guidance documents that CDRH is considering for development and providing stakeholders an opportunity to provide comments and/or draft language for those topics, or suggestions for new or different guidances. This notice announces the Web location of the list of guidances on which CDRH is intending to work over the next fiscal year. We note that the agency is not required to issue every guidance on the list, nor is it precluded from issuing guidance documents that are not on the list. The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CDRH has already issued level 1 drafts that may be finalized following review of public comments. We will consider stakeholder comments as we prioritize our guidance efforts. FDA and CDRH priorities are subject to change at any time. Topics on this and past guidance priority lists may be removed or modified based on current priorities. We also note that CDRH’s experience over the years has shown PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 that there are many reasons CDRH staff does not complete the entire annual agenda of guidances it undertakes. Staff are frequently diverted from guidance development to other activities, including review of premarket submissions or postmarket problems. In addition, the Center is required each year to issue a number of guidances that it cannot anticipate at the time the annual list is generated. These may involve newly identified public health issues as well as special control guidance documents for de novo classifications of devices. It will be helpful, therefore, to receive comments that indicate the relative priority of different guidance topics to interested stakeholders. Through feedback from stakeholders, including draft language for guidance documents, CDRH expects to be able to better prioritize and more efficiently draft guidances that will be useful to industry and other stakeholders. This will be the third annual list CDRH has posted. FDA intends to update the list each year. FDA invites interested persons to submit comments on any or all of the guidance documents on the list. FDA has established a specific docket where comments about the fiscal year 2010 list, draft language for guidance documents on those topics, and suggestions for new or different guidances may be submitted (see ADDRESSES). FDA believes this docket is an important tool for receiving information from interested parties and for sharing this information with the public. Similar information about planned guidance development is included in the annual agency-wide notice issued by FDA under its good guidance practices (21 CFR 10.115(f)(5)). This CDRH list, however, will be focused exclusively on device-related guidances and will be made available on FDA’s Web site prior to the beginning of each fiscal year from 2008 to 2012. To access the list of the guidance documents CDRH is considering for development in 2010, visit the FDA Web site https://www.fda.gov/ MedicalDevices/DeviceRegulation andGuidance/Overview/ MedicalDeviceUser FeeandModernizationActMDUFMA/ ucm109196.htm. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that E:\FR\FM\20OCN1.SGM 20OCN1 Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices individuals may submit one paper copy. Comments are to be identified 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. Comments submitted to this docket may include draft guidance documents that stakeholders have prepared for FDA’s consideration. Dated: October 2, 2009. Jeffrey Shuren, Acting Director, Center for Devices and Radiological Health. [FR Doc. E9–25179 Filed 10–19–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5283–N–02] Notice of Proposed Information Collection: Comment Request; Affirmative Fair Housing Marketing (AFHM) Plan AGENCY: Office of the Assistant Secretary for Fair Housing and Equal Opportunity, HUD. ACTION: Notice. The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act of 1995. The Department of Housing and Urban Development (the Department) is soliciting public comments on the subject proposal. DATES: Comments Due Date: December 21, 2009. ADDRESSES: Interested persons are invited to submit comments regarding this proposed information collection requirement. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Lillian L. Deitzer, Reports Management Officer, QDAM, Office of Investments Strategies, Department of Housing and Urban Development, 451 7th Street, SW., Room 4178, Washington, DC 20410–2000; e-mail Lillian.L.Deitzer@hud.gov or telephone (202) 402–8048. FOR FURTHER INFORMATION CONTACT: Pamela D. Walsh, Director, Office of Policy, Legislative Initiatives, and Outreach, Department of Housing and Urban Development, 451 7th Street, SW., Room 5224, Washington, DC 20410–2000; telephone: (202) 708–1145 (this is not a toll-free number) for copies of the proposed forms and other cprice-sewell on DSKGBLS3C1PROD with NOTICES SUMMARY: VerDate Nov<24>2008 14:46 Oct 19, 2009 Jkt 220001 available information. Hearing or speech-impaired individuals may access this number TTY by calling the toll-free Federal Information Relay Service at 1–800–877–8339. SUPPLEMENTARY INFORMATION: The Department is submitting this proposed information collection requirement to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). This Notice solicits comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed information collection is necessary for the proper performance of the functions of the agency; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information; (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 the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, information collection on responders, including the use of appropriate automated collection techniques or other forms of information technology (e.g., electronic submission of responses). This Notice also lists the following information: Title of Proposal: Affirmative Fair Housing Marketing (AFHM) Plan. Title of Regulation: Affirmative Fair Housing Marketing Regulations (24 CFR Part 200.600 and Affirmative Fair Housing Marketing Compliance Regulations (24 CFR Part 108). OMB Control Number, if applicable: 2529–0013. Description of the need for the information and proposed use: HUD uses this information to assess the adequacy of the applicant’s proposed actions to carry out the Affirmative Fair Housing Marketing requirements of 24 CFR 200.600 and review compliance with these requirements under 24 CFR Part 108, the AFHM Compliance Regulations. Agency form numbers, if applicable: HUD–935.2A Affirmative Fair Housing Marketing (AFHM) Plan (Multifamily), HUD–935.2B Affirmative Fair Housing Marketing (AFHM) Plan (SingleFamily), and HUD–935.2C Affirmative Fair Housing Market (AFHM) Plan (Condominiums or Cooperatives). Members of affected public: Applicants for mortgage insurance under the Department’s insured singlefamily and multi-family subsidized and unsubsidized programs. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 53755 Estimation of the total numbers of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response: The number of burden hours is 25,540, which includes time for initial submission, review of existing plans, and any necessary revision. On an annual basis, there are approximately 4,360 respondents who submit initial plans or updated plans. On an annual basis, an additional 3,720 respondents simply review their existing plans. The frequency of annual response is once, and the average burden hour per response is 6 hours for initial submitted plans, and 4 hours for review and updating of existing plans. Status of the proposed information collection: Extension of currently approved collection. Authority: The Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, as amended. Dated: October 9, 2009. John Malgeri, Director, Office of Program Standards and Compliance Division. [FR Doc. E9–25211 Filed 10–19–09; 8:45 am] BILLING CODE 4210–67–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS–R1–R–2009–N118; 1265–0000–10137– S3] ¯ Kealia Pond National Wildlife Refuge and Kakahai‘a National Wildlife Refuge, Maui County, HI AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of intent to prepare a comprehensive conservation plan and National Environmental Policy Act document and announcement of public open house meetings. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), intend to prepare a comprehensive conservation ¯ plan (CCP) for the Kealia Pond and Kakahai‘a National Wildlife Refuges (NWRs). We will also prepare an evaluation under the National Environmental Policy Act (NEPA) to analyze the potential environmental effects of various CCP alternatives. We provide this notice in compliance with our CCP policy to advise the public, other Federal and State agencies, and Native Hawaiian organizations of our intentions and to obtain suggestions and information on the scope of issues to be considered in the planning process. We are also announcing two public open E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[Federal Register Volume 74, Number 201 (Tuesday, October 20, 2009)]
[Notices]
[Pages 53754-53755]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25179]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0270]


Medical Device User Fee and Modernization Act; Notice to Public 
of Web Location of 2010 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the Web 
location where it will post a list of guidance documents the Center for 
Devices and Radiological Health (CDRH) is considering for development. 
In addition, FDA has established a docket where stakeholders may 
provide comments and/or draft language for those topics as well as 
suggestions for new or different guidances.

DATES: Submit written or electronic comments at any time.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. WO66, rm. 4436, Silver Spring, MD 20993, 301-796-5739.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations over the reauthorization of the Medical Device 
User Fee and Modernization Act (MDUFMA), FDA agreed, in return for 
additional funding from industry, to meet a variety of quantitative and 
qualitative goals intended to help get safe and effective medical 
devices to market more quickly. These commitments include annually 
posting a list of guidance documents that CDRH is considering for 
development and providing stakeholders an opportunity to provide 
comments and/or draft language for those topics, or suggestions for new 
or different guidances. This notice announces the Web location of the 
list of guidances on which CDRH is intending to work over the next 
fiscal year. We note that the agency is not required to issue every 
guidance on the list, nor is it precluded from issuing guidance 
documents that are not on the list. The list includes topics that 
currently have no guidance associated with them, topics where updated 
guidance may be helpful, and topics for which CDRH has already issued 
level 1 drafts that may be finalized following review of public 
comments. We will consider stakeholder comments as we prioritize our 
guidance efforts.
    FDA and CDRH priorities are subject to change at any time. Topics 
on this and past guidance priority lists may be removed or modified 
based on current priorities. We also note that CDRH's experience over 
the years has shown that there are many reasons CDRH staff does not 
complete the entire annual agenda of guidances it undertakes. Staff are 
frequently diverted from guidance development to other activities, 
including review of premarket submissions or postmarket problems. In 
addition, the Center is required each year to issue a number of 
guidances that it cannot anticipate at the time the annual list is 
generated. These may involve newly identified public health issues as 
well as special control guidance documents for de novo classifications 
of devices. It will be helpful, therefore, to receive comments that 
indicate the relative priority of different guidance topics to 
interested stakeholders.
    Through feedback from stakeholders, including draft language for 
guidance documents, CDRH expects to be able to better prioritize and 
more efficiently draft guidances that will be useful to industry and 
other stakeholders. This will be the third annual list CDRH has posted. 
FDA intends to update the list each year.
    FDA invites interested persons to submit comments on any or all of 
the guidance documents on the list. FDA has established a specific 
docket where comments about the fiscal year 2010 list, draft language 
for guidance documents on those topics, and suggestions for new or 
different guidances may be submitted (see ADDRESSES). FDA believes this 
docket is an important tool for receiving information from interested 
parties and for sharing this information with the public. Similar 
information about planned guidance development is included in the 
annual agency-wide notice issued by FDA under its good guidance 
practices (21 CFR 10.115(f)(5)). This CDRH list, however, will be 
focused exclusively on device-related guidances and will be made 
available on FDA's Web site prior to the beginning of each fiscal year 
from 2008 to 2012.
    To access the list of the guidance documents CDRH is considering 
for development in 2010, visit the FDA Web site https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that

[[Page 53755]]

individuals may submit one paper copy. Comments are to be identified 
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. Comments 
submitted to this docket may include draft guidance documents that 
stakeholders have prepared for FDA's consideration.

    Dated: October 2, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-25179 Filed 10-19-09; 8:45 am]
BILLING CODE 4160-01-S
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