Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed, 34744-34745 [2010-14813]

Download as PDF srobinson on DSKHWCL6B1PROD with NOTICES 34744 Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices Information Collection: Collection Requirements for Compendia for Determination of Medically-accepted Indications for Off-label Uses of Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen Use: Congress enacted the Medicare Improvement of Patients and Providers Act (MIPPA). Section 182(b) of MIPPA amended Section 1861(t)(2)(B) of the Social Security Act (42 U.S.C. 1395x(t)(2)(B)) by adding at the end the following new sentence: ‘On and after January 1, 2010, no compendia may be included on the list of compendia under this subparagraph unless the compendia has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interest.’ We believe that the implementation of this statutory provision that compendia have a ‘‘publicly transparent process for evaluating therapies and for identifying potential conflicts of interests’’ is best accomplished by amending 42 CFR 414.930 to include the MIPPA requirements and by defining the key components of publicly transparent processes for evaluating therapies and for identifying potential conflicts of interests. All currently listed compendia will be required to comply with these provisions, as of January 1, 2010, to remain on the list of recognized compendia. In addition, any compendium that is the subject of a future request for inclusion on the list of recognized compendia will be required to comply with these provisions. No compendium can be on the list if it does not fully meet the standard described in section 1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA. Form Number: CMS–10302 (OMB#: 0938– 1078); Frequency: Reporting, Recordkeeping and Third-party disclosure; Affected Public: Business and other for-profits and Not-for-profit institutions; Number of Respondents: 845; Total Annual Responses: 900; Total Annual Hours: 5,135. (For policy questions regarding this collection contact Brijet Burton at 410–786–7364. For all other issues call 410–786–1326.) 7. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: End Stage Renal Disease (ESRD) Medical Information Facility Survey; Form Number: CMS–2744 (OMB#: 0938– 0447); Use: The End Stage Renal Disease (ESRD) Medical Information Facility Survey form (CMS–2744) is completed annually by Medicare-approved providers of dialysis and transplant services. The CMS–2744 is designed to VerDate Mar<15>2010 16:17 Jun 17, 2010 Jkt 220001 collect information concerning treatment trends, utilization of services and patterns of practice in treating ESRD patients. The information is used to assess and evaluate the local, regional and national levels of medical and social impact of ESRD care and is used extensively by researchers and suppliers of services for trend analysis. The information is available on the CMS Dialysis Facility Compare website and will enable patients to make informed decisions about their care by comparing dialysis facilities in their area. Frequency: Yearly; Affected Public: Business or other for-profit, Not-forprofit institutions; Number of Respondents: 5,465; Total Annual Responses: 5,465; Total Annual Hours: 43,720. (For policy questions regarding this collection contact Connie Cole at 410–786–0257. For all other issues call 410–786–1326.) 8. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: End Stage Renal Disease Death Notification P.L. 95–292; 42 CFR 405.2133, 45 CFR 5–5b; 20 CFR Parts 401 and 422E Use: The ESRD Death Notification (CMS– 2746) is completed by all Medicareapproved ESRD facilities upon the death of an ESRD patient. Its primary purpose is to collect fact of death and cause of death of ESRD patients. Certain other identifying information (e.g., name, Medicare claim number, and date of birth) is required for matching purposes. Federal regulations require that the ESRD Networks examine the mortality rates of every Medicare-approved facility within its area of responsibility. The Death Form provides the necessary data to assist the ESRD Networks in making decisions that result in improved patient care and in costeffective distribution of ESRD resources. The data is used by the ESRD Networks to verify facility deaths and to monitor facility performance. Form Number: CMS–2746 (OMB#: 0938–0448); Frequency: On occasion; Affected Public: Business or other for-profit, Notfor-profit institutions; Number of Respondents: 5,173; Total Annual Responses: 82,768; Total Annual Hours: 41,384. (For policy questions regarding this collection contact Connie Cole at 410–786–0257. For all other issues call 410–786–1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on July 19, 2010. OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–6974, E-mail: OIRA_submission@omb.eop.gov. Dated: June 15, 2010. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2010–14780 Filed 6–17–10; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0083] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 19, 2010. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0339. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., E:\FR\FM\18JNN1.SGM 18JNN1 34745 Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices P150—400B, Rockville, MD 20850, 301– 796–3793. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed—(OMB Control Number 0910–0339)—Extension This information collection was established because epidemiological evidence gathered in the United Kingdom suggested that bovine spongiform encephalopathy (BSE), a progressively degenerative central nervous system disease, is spread to ruminant animals by feeding protein derived from ruminants infected with BSE. This regulation places general requirements on persons that manufacture, blend, process, and distribute products that contain or may contain protein derived from mammalian tissue, and feeds made from such products. In the Federal Register of February 26, 2010 (75 FR 8959), FDA published a 60-day notice requesting public comment on the proposed collection of information. In response, FDA received one comment. This comment was outside the scope of the four topics discussed in the 60-day notice. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers 21 CFR Section 589.2000(e)(1)(iv) 1 There 400 [FR Doc. 2010–14813 Filed 6–17–10; 8:45 am] BILLING CODE S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0267] Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on Consumers’ Emotional and Cognitive Reactions to Food Recalls Food and Drug Administration, HHS. srobinson on DSKHWCL6B1PROD with NOTICES ACTION: Total Annual Records 1 Hours per Record 400 Total Hours 14 5,600 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 14, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. AGENCY: Annual Frequency per Recordkeeping Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey on Consumers’ Emotional and Cognitive Reactions to Food Recalls. DATES: Submit either electronic or written comments on the collection of information by August 17, 2010. ADDRESSES: Submit electronic comments on the collection of information to https:// VerDate Mar<15>2010 16:17 Jun 17, 2010 Jkt 220001 www.regulations.gov. Submit written comments on the collection of information 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: Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Survey on Consumers’ Emotional and Cognitive Reactions to Food Recalls— 21 U.S.C. 393(d)(2)(C) (OMB Control Number 0910–NEW) I. Background The proposed ‘‘Survey on Consumers’ Emotional and Cognitive Reactions to Food Recalls’’ will be conducted under a cooperative agreement between the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the Center for Risk Communication Research at the University of Maryland. JIFSAN was established in 1996 and is a public and private partnership between FDA and the University of Maryland. The Center for Risk Communication Research will design and administer the study. The proposed study will assess consumers’ emotional and cognitive recollection of certain food recalls and gauge how these recollections affect their current perceptions about food recalls and their inclination to adhere to future recommended food recall behaviors. Existing data show that many consumers do not take appropriate protective actions during a foodborne illness outbreak or food recall (Refs. 1 E:\FR\FM\18JNN1.SGM 18JNN1

Agencies

[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34744-34745]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14813]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0083]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substances Prohibited
From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant
Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
19, 2010.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0339.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,

[[Page 34745]]

P150--400B, Rockville, MD 20850, 301-796-3793.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Substances Prohibited From Use in Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed--(OMB Control Number 0910-0339)--Extension

This information collection was established because epidemiological
evidence gathered in the United Kingdom suggested that bovine
spongiform encephalopathy (BSE), a progressively degenerative central
nervous system disease, is spread to ruminant animals by feeding
protein derived from ruminants infected with BSE. This regulation
places general requirements on persons that manufacture, blend,
process, and distribute products that contain or may contain protein
derived from mammalian tissue, and feeds made from such products.
In the Federal Register of February 26, 2010 (75 FR 8959), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. In response, FDA received one comment. This
comment was outside the scope of the four topics discussed in the 60-
day notice.
FDA estimates the burden of this collection of information as
follows:

Table 1.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Total Annual
Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
589.2000(e)( 400 1 400 14 5,600
1)(iv)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Dated: June 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-14813 Filed 6-17-10; 8:45 am]
BILLING CODE S

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