Source: https://regulations.justia.com/regulations/fedreg/2008/12/17/E8-29898.html
Timestamp: 2020-08-11 10:35:26
Document Index: 138161963

Matched Legal Cases: ['art 225', '§ 225', 'art 607', 'art 607', 'art 607', 'art 607']

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830, 76654-76655 [E8-29898] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830, 76654-76655 [E8-29898]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830, 76654-76655 [E8-29898]
Download as PDF 76654 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices shares up to 9.9 percent of the voting shares of Chinatrust Financial Holding Company, Ltd., Taipei, Taiwan, and thereby acquire Chinatrust Bank (U.S.A.), Torrance, California. Board of Governors of the Federal Reserve System, December 12, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E8–29913 Filed 12–16–08; 8:45 am] Board of Governors of the Federal Reserve System, December 12, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E8–29914 Filed 12–16–08; 8:45 am] BILLING CODE 6210–01–S BILLING CODE 6210–01–S Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2008–N–0439] FEDERAL RESERVE SYSTEM pwalker on PROD1PC71 with NOTICES Notice of Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR Part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Additional information on all bank holding companies may be obtained from the National Information Center website at www.ffiec.gov/nic/. Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 12, 2008. A. Federal Reserve Bank of Richmond (A. Linwood Gill, III, Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528: 1. Capital One Financial Corporation, McLean, Virginia; to acquire Chevy Chase Bank, Federal Savings Bank, McLean, Virginia, and thereby engage in operation a savings and loan association pursuant to section 225.28(b)(4)(ii) of Regulation Y. VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830 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 January 16, 2009. 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: 202–395–6974, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0052. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3794. 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. Blood Establishment Registration and Product Listing, Form FDA 2830— (OMB Control Number 0910–0052)— Extension Under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), any person owning or operating an establishment that manufactures, prepares, propagates, compounds, or PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 processes a drug or device must register with the Secretary of Health and Human Services, on or before December 31 of each year, his or her name, place of business, and all such establishments, and must submit, among other information, a listing of all drug or device products manufactured, prepared, propagated, compounded, or processed by him or her for commercial distribution. In part 607 (21 CFR part 607), FDA has issued regulations implementing these requirements for manufacturers of human blood and blood products. Section 607.20(a), in brief, requires owners or operators of certain establishments that engage in the manufacture of blood products to register and to submit a list of every blood product in commercial distribution. Section 607.21, in brief, requires the owners or operators of establishments entering into the manufacturing of blood products to register within 5 days after beginning such operation and to submit a list of every blood product in commercial distribution at the time. If the owner or operator of the establishment has not previously entered into such operation for which a license is required, registration must follow within 5 days after the submission of a biologics license application. In addition, establishments are required to register annually between November 15 and December 31 and update their blood product listing every June and December of each year. Section 607.22 requires the use of Form FDA 2830, Blood Establishment Registration and Product Listing, for initial registration, for annual registration, and for blood product listing. Section 607.25 indicates the information required for establishment registration and blood product listing. Section 607.26, in brief, requires certain changes to be submitted on FDA Form 2830 as amendments to the establishment registration within 5 days of such changes. Section 607.30(a), in brief, indicates the information required for owners or operators of establishments to update their blood product listing information every June and December, or at the discretion of the registrant at the time the change occurs. Section 607.31 requires that additional blood product listing information be provided upon FDA request. Section 607.40, in brief, requires certain foreign blood product establishments to register and submit the blood product listing information, and to provide the name and address of the establishment and the name of the individual responsible for submitting blood product listing E:\FR\FM\17DEN1.SGM 17DEN1 76655 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices information as well as the name, address, and phone number of its U.S. agent. Among other uses, this information assists FDA in its inspections of facilities, and its collection is essential to the overall regulatory scheme designed to ensure the safety of the nation’s blood supply. Form FDA 2830 is used to collect this information. Respondents to this collection of information are human blood and plasma donor centers, blood banks, certain transfusion services, other blood product manufacturers, and independent laboratories that engage in quality control and testing for registered blood product establishments. FDA estimates the burden of this collection of information based upon information obtained from FDA’s Center for Biologics Evaluation and Research’s database and FDA experience with the blood establishment registration and product listing requirements. The time needed for industry to complete the Form FDA 2830 is estimated to be 1 hour for new firms. The blood establishments for the most part are familiar with the regulations and registration requirements to fill out this form for the first time. Approximately 111 new Form FDA 2830s are received annually. With annual re-registration of blood establishments, the time needed for industry to complete the Form FDA 2830 is estimated to be 0.5 hours. The blood establishments need only to refer to their files or written instructions for a small portion of the information required. Approximately 2,621 Form FDA 2830s are received annually for reregistration. Approximately 180 Form FDA 2830s are received annually for the product listing update with an estimated average of 0.25 hours to complete the form. In the Federal Register of August 12, 2008 (73 FR 46909), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section Form FDA 2830 607.20(a), 607.21, 607.22, 607.25, and 607.40 Initial Registration 607.21, 607.22, 607.25, 607.26, 607.31, and 607.40 Re-registration 607.21, 607.25, 607.30(a), 607.31, and 607.40 No. of Respondents Product Listing Update Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 111 1 111 1 111 2,621 1 2,621 0.5 1,311 180 1 180 0.25 45 Total 1,467 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 10, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–29898 Filed 12–16–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0606] Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES ACTION: 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 VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements imposed on firms that intend to export to countries that require an export certificate as a condition of entry for FDA regulated products, pharmaceuticals, biologics, and devices as indicated in the Federal Food, Drug, and Cosmetic Act (the act) as amended. DATES: Submit written or electronic comments on the collection of information by February 17, 2009. ADDRESSES: Submit electronic comments on the collection of information to http:// 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. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3794. 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, including each proposed extension of an existing 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\17DEN1.SGM 17DEN1
[Pages 76654-76655]
[FR Doc No: E8-29898]
[Docket No. FDA-2008-N-0439]
of Management and Budget Review; Comment Request; Blood Establishment
Registration and Product Listing, Form FDA 2830
comments should be identified with the OMB control number 0910-0052.
Blood Establishment Registration and Product Listing, Form FDA 2830--
(OMB Control Number 0910-0052)--Extension
on or before December 31 of each year, his or her name, place of
business, and all such establishments, and must submit, among other
information, a listing of all drug or device products manufactured,
commercial distribution. In part 607 (21 CFR part 607), FDA has issued
regulations implementing these requirements for manufacturers of human
distribution. Section 607.21, in brief, requires the owners or
operators of establishments entering into the manufacturing of blood
products to register within 5 days after beginning such operation and
to submit a list of every blood product in commercial distribution at
the time. If the owner or operator of the establishment has not
previously entered into such operation for which a license is required,
biologics license application. In addition, establishments are required
to register annually between November 15 and December 31 and update
their blood product listing every June and December of each year.
Section 607.22 requires the use of Form FDA 2830, Blood Establishment
Registration and Product Listing, for initial registration, for annual
registration, and for blood product listing. Section 607.25 indicates
the information required for establishment registration and blood
product listing. Section 607.26, in brief, requires certain changes to
be submitted on FDA Form 2830 as amendments to the establishment
registration within 5 days of such changes. Section 607.30(a), in
brief, indicates the information required for owners or operators of
establishments to update their blood product listing information every
June and December, or at the discretion of the registrant at the time
the change occurs. Section 607.31 requires that additional blood
product listing information be provided upon FDA request. Section
607.40, in brief, requires certain foreign blood product establishments
to register and submit the blood product listing information, and to
provide the name and address of the establishment and the name of the
individual responsible for submitting blood product listing
information as well as the name, address, and phone number of its U.S.
of facilities, and its collection is essential to the overall
supply. Form FDA 2830 is used to collect this information.
registration and product listing requirements. The time needed for
industry to complete the Form FDA 2830 is estimated to be 1 hour for
new firms. The blood establishments for the most part are familiar with
the regulations and registration requirements to fill out this form for
the first time. Approximately 111 new Form FDA 2830s are received
annually. With annual re-registration of blood establishments, the time
needed for industry to complete the Form FDA 2830 is estimated to be
0.5 hours. The blood establishments need only to refer to their files
or written instructions for a small portion of the information
required. Approximately 2,621 Form FDA 2830s are received annually for
re-registration. Approximately 180 Form FDA 2830s are received annually
for the product listing update with an estimated average of 0.25 hours
In the Federal Register of August 12, 2008 (73 FR 46909), FDA
Form FDA        No. of       Annual Frequency    Total Annual      Hours per
21 CFR Section      2830        Respondents      per Response        Responses       Response       Total Hours
607.20(a),      Initial                  111                   1             111               1             111
607.21,         Registratio
607.22,         n
607.25, and
607.21,         Re-                    2,621                   1           2,621             0.5           1,311
607.22,         registratio
607.25,         n
607.26,
607.31, and
607.21,         Product                  180                   1             180            0.25              45
607.25,         Listing
607.30(a),      Update
Total                                                                                                      1,467