Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus-Developing Medical Products for Treatment; Withdrawal of Guidance, 38305-38306 [2012-15716]

Download as PDF 38305 Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers 21 CFR Section Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours 314.80(i) ........................................................... 665 601.5 399,998 16 6,399,968 Total .......................................................... ............................ ............................ ............................ ............................ 6,400,368 1 There are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually. These estimates are based on FDA’s knowledge of adverse drug experience reporting, including the time needed to prepare the reports, and the number of reports submitted to the Agency. Dated: June 22, 2012. Leslie Kux, Assistant Commissioner for Policy. information collection and has assigned OMB control number 0910–0710. The approval expires on June 30, 2014. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: June 18, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–15708 Filed 6–26–12; 8:45 am] BILLING CODE 4160–01–P [FR Doc. 2012–15714 Filed 6–26–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0640] Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Data To Support Food and Nutrition Product Communications as Used by the Food and Drug Administration Dated: June 20, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–15696 Filed 6–26–12; 8:45 am] [Docket No. FDA–2009–N–0535] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Data to Support Food and Nutrition Product Communications as Used by the Food and Drug Administration’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Denver Presley II, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUPPLEMENTARY INFORMATION: On May 27, 2011, the Agency submitted a proposed collection of information entitled ‘‘Data to Support Food and Nutrition Product Communications as Used by the Food and Drug Administration’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the SUMMARY: srobinson on DSK4SPTVN1PROD with NOTICES Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0711. The approval expires on October 31, 2013. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. VerDate Mar<15>2010 19:05 Jun 26, 2012 Jkt 226001 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; ‘‘Real Time’’ Surveys of Consumers’ Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘‘Real Time’ Surveys of Consumers’ Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Denver Presley II, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUPPLEMENTARY INFORMATION: On June 27, 2011, the Agency submitted a proposed collection of information entitled ‘‘‘Real Time’ Surveys of Consumers’ Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls’’ to OMB for review and clearance under 44 U.S.C. 3507. An SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0249] Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus—Developing Medical Products for Treatment; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance published in the Federal Register of June 22, 2010. DATES: June 27, 2012. FOR FURTHER INFORMATION CONTACT: Leila P. Hann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 22, rm. 3143, Silver Spring, MD 20993–0002, 301– 796–3367; or Philip Desjardins, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. 5437, Silver Spring, MD 20993–0002, 301– 796–5678; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), SUMMARY: E:\FR\FM\27JNN1.SGM 27JNN1 38306 Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Notices Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of June 22, 2010 (75 FR 35492), FDA announced the availability of a guidance entitled ‘‘Lupus Nephritis Caused By Systemic Lupus Erythematosus— Developing Medical Products for Treatment.’’ This guidance is being withdrawn because it does not reflect FDA’s current thinking on the development of medical products for the treatment of lupus nephritis. Dated: June 22, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–15716 Filed 6–26–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS–2011–0116] GFIRST Conference Stakeholder Evaluation National Protection and Programs Directorate, DHS. ACTION: 30–Day Notice and request for comments; New Information Collection Request: 1670–NEW. AGENCY: The Department of Homeland Security (DHS), National Protection and Programs Directorate (NPPD), Office of Cybersecurity and Communications (CS&C), National Cyber Security Division (NCSD), United States Computer Emergency Readiness Team (US–CERT) will submit the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chapter 35). NPPD is soliciting comments concerning new Information Collection Request— GFIRST Conference Stakeholder Evaluation. DHS previously published this ICR in the Federal Register on February 29, 2012, for a 60-day public comment period. DHS received two comments. The purpose of this notice is to allow an additional 30 days for public comments. DATES: Comments are encouraged and will be accepted until July 27, 2012. This process is conducted in accordance with 5 CFR 1320.10. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:05 Jun 26, 2012 Jkt 226001 Affairs, OMB. Comments should be addressed to OMB Desk Officer, DHS, Office of Civil Rights and Civil Liberties. Comments must be identified by ‘‘DHS– 2011–0116’’ and may be submitted by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. • Email: oira_submission@omb.eop.gov. Include the docket number in the subject line of the message. • Fax: (202) 395–5806. Instructions: All submissions received must include the words ‘‘Department of Homeland Security’’ and the docket number for this action. Comments received will be posted without alteration at https://www.regulations.gov, including any personal information provided. OMB is particularly interested in comments that: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 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 through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. FOR FURTHER INFORMATION CONTACT: Corliss McCain, DHS/NPPD/CS&C/ NCSD/US–CERT, Corliss.McCain@dhs.gov. GFIRST is DHS’s premier cyber conference and continually seeks to enhance collaborative efforts among cyber constituencies, partners, and stakeholders. The data provided will assist GFIRST planners in areas of improvement and efficiency. With the survey responses, we can better tailor our events, materials, and activities to improve efforts to protect our Nation’s cybersecurity. As part of the National Strategy for a Secure Cyberspace, US– CERT is required to assist in the fight against the disruption of the operation of critical information systems. The National Strategy for a Secure Cyberspace requires US–CERT to assist SUPPLEMENTARY INFORMATION: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 in the continuous assessment of threats and vulnerabilities to Federal cyber systems. As part of our mission, US– CERT is required to assist and urge state and local governments to consider establishing information technology security programs and participate in information sharing and analysis centers with similar governments. The GFIRST conference provides an annual forum to network with public and private stakeholders, while also acting as a conduit for state and local government information sharing critical to securing our Nation’s cyberspace. US–CERT received two comments from the 60-day comment window: • Public Comment DHS–2011–0116– 002—Summary: The comment referenced an issue with completing the new I–9 Form and instructions. Æ Action by Agency: NPPD will take no action to update the GFIRST Conference Stakeholder Evaluation Forms. There is no reference to the I–9 Form on the GFIRST Conference Stakeholder Evaluation Forms (DHS Form 9050 and DHS Form 9051). • Public Comment DHS–2011–0116– 003—Summary: The comment referenced the total burden cost. A suggestion was made to evaluate the accuracy of the estimated burden cost. There was also a question as to whether the benefit of the survey would outweigh the costs. Æ Action by Agency: NPPD will take no action to update the GFIRST Conference Stakeholder Evaluation Forms. The Total Burden Cost is the total annual costs for operating/ maintaining costs for the 1,000 (approximate number) respondents. Analysis Agency: The Department of Homeland Security, National Protection and Programs Directorate, Office of Cybersecurity and Communications, United States Computer Emergency Readiness Team. Title: GFIRST Conference Stakeholder Evaluation. OMB Number: 1670–NEW. Frequency: Annually. Affected Public: Conference attendees, comprising the general public. Number of Respondents: 1,000 respondents. Estimated Time Per Respondent: 2 minutes. Total Burden Hours: 16.6 annual burden hours. Total Burden Cost (capital/startup): $0. Total Recordkeeping Burden: $0. Total Burden Cost (operating/ maintaining): $675.95. E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38305-38306]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15716]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0249]


Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus 
Erythematosus--Developing Medical Products for Treatment; Withdrawal of 
Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of a guidance published in the Federal Register of June 22, 
2010.

DATES: June 27, 2012.

FOR FURTHER INFORMATION CONTACT: Leila P. Hann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 22, rm. 3143, Silver Spring, MD 20993-0002, 301-
796-3367;
    or

Philip Desjardins, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. 5437, 
Silver Spring, MD 20993-0002, 301-796-5678;
    or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),

[[Page 38306]]

Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 22, 2010 (75 FR 35492), FDA announced the availability 
of a guidance entitled ``Lupus Nephritis Caused By Systemic Lupus 
Erythematosus--Developing Medical Products for Treatment.'' This 
guidance is being withdrawn because it does not reflect FDA's current 
thinking on the development of medical products for the treatment of 
lupus nephritis.

    Dated: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15716 Filed 6-26-12; 8:45 am]
BILLING CODE 4160-01-P

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