Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830, 46909-46911 [E8-18570]

Download as PDF sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 73, No. 156 / Tuesday, August 12, 2008 / Notices should be made for deliveries of boxed information. If you provide comments by mail or hand delivery, please submit three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies. Instructions: Direct your comments to Docket ID No. EPA–HQ–OAR–007– 1145. Please ensure that your comments are submitted within the specified comment period. Comments received after the closing date will be marked ‘‘late,’’ and may only be considered if time permits. It is EPA’s policy to include all comments it receives in the public docket without change and to make the comments available online at http://www.regulations.gov, including any personal information provided, unless a comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http:// www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through http:// www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. 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Publicly available docket materials are available either electronically in http:// VerDate Aug<31>2005 16:24 Aug 11, 2008 Jkt 214001 www.regulations.gov or in hard copy at the OEI Docket in the EPA Headquarters Docket Center. Dated: August 1, 2008. Rebecca Clark, Acting Director, National Center for Environmental Assessment. [FR Doc. E8–18610 Filed 8–11–08; 8:45 am] BILLING CODE 6560–50–P 46909 a. Monthly Participant Activity Report b. Legislative Report c. Investment Performance Report 3. Report on Potential Risk of Loss to TSP Assets as a result of the Theoretical Insolvency of Barclays Global Investors Parts Closed to the Public 4. Procurement CONTACT PERSON FOR MORE INFORMATION: FEDERAL RESERVE SYSTEM Change in Bank Control Notices, Acquisition of Shares of Bank or Bank Holding Companies; Correction This notice corrects a notice (FR Doc. E8–18107 published on pages 46005 and 46006 of the issue for Thursday, August 7, 2008. Under the Federal Reserve Bank of Kansas City heading, the entry for The Schifferdecker Limited Partnersip, Girard, Kansas, is revised to read as follows: A. Federal Reserve Bank of Kansas City (Todd Offenbacker, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. The Schifferdecker Limited Partnership, Girard, Kansas; Mark W. Schifferdecker, Girard, Kansas; Susan B. Friesen, Omaha, Nebraska; and Joy L. Shoop, Hiawatha, Kansas; as general partners, to acquire control of GN Bankshares, Inc., and thereby indirectly aacquire control of The Girard National Bank, both in Girard, Kansas. Comments on this application must be received by August 21, 2008. Board of Governors of the Federal Reserve System, August 7, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E8–18554 Filed 8–11–08; 8:45 am] BILLING CODE 6210–01–S FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Sunshine Act; Notice of Meeting 10 a.m. (Eastern Time), August 18, 2008. PLACE: 4th Floor Conference Room, 1250 H Street, NW., Washington, DC 20005. STATUS: Parts will be open to the public and parts closed to the public. MATTERS TO BE CONSIDERED: TIME AND DATE: Parts Open to the Public 1. Approval of the minutes of the July 21, 2008 Board member meeting 2. Thrift Savings Plan activity report by the Executive Director PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Thomas J. Trabucco, Director, Office of External Affairs, (202) 942–1640. Dated: August 8, 2008. Thomas K. Emswiler, Secretary, Federal Retirement Thrift Investment Board. [FR Doc. E8–18682 Filed 8–8–08; 12:00 pm] BILLING CODE 6760–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0439 ] Agency Information Collection Activities; Proposed Collection; 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 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, 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 the information collection requirements relating to the blood establishment registration and product listing requirements in the agency’s regulations and Form FDA 2830. DATES: Submit written or electronic comments on the collection of information by October 14, 2008. 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 E:\FR\FM\12AUN1.SGM 12AUN1 46910 Federal Register / Vol. 73, No. 156 / Tuesday, August 12, 2008 / Notices comments should be identified with the 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: 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. 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 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. Blood Establishment Registration and Product Listing, Form FDA 2830—21 CFR Part 607 (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 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 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. FDA estimates the burden of this collection as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section Form FDA 2830 sroberts on PROD1PC70 with NOTICES 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 No. of Respondents Re-registration VerDate Aug<31>2005 16:24 Aug 11, 2008 Jkt 214001 PO 00000 Annual Frequency per Response Total Annual Responses Hours Per Response Total Hours 111 111 1 111 2,621 Frm 00042 1 1 2,621 0.5 1,311 Fmt 4703 Sfmt 4703 E:\FR\FM\12AUN1.SGM 12AUN1 46911 Federal Register / Vol. 73, No. 156 / Tuesday, August 12, 2008 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 21 CFR Section 607.21, 607.25, 607.30(a), 607.31, and 607.40 Form FDA 2830 No. of Respondents Product Listing Update Annual Frequency per Response 180 Total Annual Responses 1 Hours Per Response 180 Total 1 There 45 1,467 are no capital costs or operating and maintenance costs associated with this collection of information. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. Dated: August 5, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–18570 Filed 8–11–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Advisory Commission on Childhood Vaccines (ACCV). Date and Time: September 4, 2008, 1 p.m. to 5 p.m. EDT. September 5, 2008, 8 a.m. to 12 p.m. EDT. Place: Parklawn Building (and via audio conference call), Conference Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857. The ACCV will meet on Thursday, September 4 from 1 p.m. to 5 p.m. (EDT) and Friday, September 5 from 9 a.m. to 12 p.m. (EDT). The public can join the meeting via audio conference call by dialing 1–888–220– 3083 on September 4 & 5 and providing the following information: Leader’s Name: Dr. Geoffrey Evans. Password: ACCV. Agenda: The agenda items for the September meeting will include, but are not limited to: updates from the Division of Vaccine Injury Compensation (DVIC), Department of Justice, National Vaccine Program Office, Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health), and Center for Biologics, Evaluation and Research (Food and Drug Administration). Agenda VerDate Aug<31>2005 16:24 Aug 11, 2008 Jkt 214001 items are subject to change as priorities dictate. Public Comments: Persons interested in providing an oral presentation should submit a written request, along with a copy of their presentation to: Michelle Herzog, DVIC, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 11C–26, 5600 Fishers Lane, Rockville, Maryland 20857 or e-mail: mherzog@hrsa.gov. Requests should contain the name, address, telephone number, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The allocation of time may be adjusted to accommodate the level of expressed interest. DVIC will notify each presenter by mail or telephone of their assigned presentation time. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may announce it at the time of the comment period. These persons will be allocated time as it permits. FOR FURTHER INFORMATION CONTACT: Advisory Commission on Childhood Vaccines; Notice of Meeting sroberts on PROD1PC70 with NOTICES 0.25 Total Hours Anyone requiring information regarding the ACCV should contact Michelle Herzog, DVIC, HSB, HRSA, Room 11C– 26, 5600 Fishers Lane, Rockville, MD 20857; telephone (301) 443–6593 or email: mherzog@hrsa.gov. Dated: August 7, 2008. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E8–18630 Filed 8–11–08; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Date and Time: September 15, 2008, 10 a.m.–1 p.m. Eastern Standard Time (EST). Place: (Audio Conference Call). Status: The meeting will be open to the public; audio conference access limited only by availability of telephone ports. Purpose: The Advisory Committee provides advice and recommendations on a broad range of issues dealing with programs and activities authorized under section 747 of the Public Health Service Act as amended by The Health Professions Education Partnership Act of 1998, Public Law 105– 392. At this meeting the Advisory Committee will finalize its seventh report on the topic of primary care providing a medical/dental home within the health care system. It will begin work on its eighth report on the topic of the redesign of primary care and its impact on training and Title VII, section 747. Reports are submitted to Congress and to the Secretary of the Department of Health and Human Services. Agenda: The agenda includes final approval of the recommendations and finalization of the seventh report as a whole. The Advisory Committee will plan the process for completion of the eighth report on the redesign of primary care training. An opportunity will be provided for public comment. Agenda items are subject to change as dictated by the priorities of the Advisory Committee. Supplementary Information: The ACTPCMD will convene on Monday, September 15 from 10 a.m. to 1 p.m. EST via audio conference. To participate in this audio conference call, please dial the toll-free number 1–800–475–0478 and provide the numeric passcode: 2219205. Anyone interested in participating in the audio conference should notify either Jerilyn K. Glass, M.D., Ph.D., or Anne F. Patterson by calling 301–443–6822 prior to September 8. For Further Information Contact: Anyone requesting information regarding the Advisory Committee should contact Jerilyn K. Glass, Designated Federal Official for the ACTPCMD, Bureau of Health Professions, Health Resources and Services Administration, Room 9A–27, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone (301) 443–6822. The Web address for information on the Advisory Committee is http://bhpr.hrsa.gov/ medicine-dentistry/actpcmd. Dated: August 7, 2008. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E8–18631 Filed 8–11–08; 8:45 am] BILLING CODE 4165–15–P E:\FR\FM\12AUN1.SGM 12AUN1

Agencies

[Federal Register Volume 73, Number 156 (Tuesday, August 12, 2008)]
[Notices]
[Pages 46909-46911]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18570]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0439 ]


Agency Information Collection Activities; Proposed Collection; 
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 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, 
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 the information collection 
requirements relating to the blood establishment registration and 
product listing requirements in the agency's regulations and Form FDA 
2830.

DATES: Submit written or electronic comments on the collection of 
information by October 14, 2008.

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

[[Page 46910]]

comments should be identified with the 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: 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.
    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 
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.

Blood Establishment Registration and Product Listing, Form FDA 2830--21 
CFR Part 607 (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 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 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.
    FDA estimates the burden of this collection as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                  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
 607.40
----------------------------------------------------------------------------------------------------------------
607.21,         Re-                    2,621                   1           2,621             0.5           1,311
 607.22,         registratio
 607.25,         n
 607.26,
 607.31, and
 607.40
----------------------------------------------------------------------------------------------------------------

[[Page 46911]]

 
607.21,         Product                  180                   1             180            0.25              45
 607.25,         Listing
 607.30(a),      Update
 607.31, and
 607.40
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      1,467
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: August 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18570 Filed 8-11-08; 8:45 am]
BILLING CODE 4160-01-S