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 http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

http://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 

[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 http:// 

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 http://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 


cprice-sewell on DSKGBLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 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 

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. 

SUMMARY: 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 

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. 

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] 

Kea ̄lia 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 Kea ̄lia 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 


cprice-sewell on DSKGBLS3C1PROD with NOTICES