Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Food and Drug Administration Form 2830, 79691-79692 [2011-32777]

Download as PDF 79691 Federal Register / Vol. 76, No. 246 / Thursday, December 22, 2011 / Notices Dated: December 16, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. collection of information to OMB for review and clearance. [FR Doc. 2011–32776 Filed 12–21–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0508] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Food and Drug Administration Form 2830 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 23, 2012. 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 emailed 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. SUMMARY: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, (301) 796– 7726, Ila.Mizrachi@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed FOR FURTHER INFORMATION CONTACT: Blood Establishment Registration and Product Listing, FDA Form 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, owners or operators of all establishments so engaged must register annually between November 15 and December 31 and must update their blood product listing information every June and December. Section 607.22 requires the use of FDA Form 2830 (Blood Establishment Registration and Product Listing) for initial registration, subsequent annual registration, and for blood product listing information. Section 607.25 sets forth 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 an amendment to establishment registration within 5 days of such changes. Section 607.30(a), in brief, sets forth the information required from owners or operators of establishments when updating 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 comply with the establishment registration and blood product listing information requirements discussed earlier in this document and to provide the name and address of the establishment and the name of the individual responsible for submitting establishment registration and 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. FDA Form 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. In the Federal Register of August 8, 2011 (76 FR 48167), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: jlentini on DSK4TPTVN1PROD with NOTICES TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Total annual responses Average burden per response 49 1 49 1 49 2,589 1 2,589 0.5 (30 min.) 1,295 Number of respondents 21 CFR Section FDA Form 2830 607.20(a), 607.21, 607.22, 607.25, and 607.40. 607.21, 607.22, 607.25, 607.26, 607.31, and 607.40. Initial registration ........................ Re-registration ............................ VerDate Mar<15>2010 19:17 Dec 21, 2011 Jkt 226001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\22DEN1.SGM 22DEN1 Total hours 79692 Federal Register / Vol. 76, No. 246 / Thursday, December 22, 2011 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 21 CFR Section 607.21, 607.25, 607.30(a), 607.31, and 607.40. Total hours 180 0.25 (15 min.) 45 ..................................................... ........................ ........................ .................... .................... 1,389 are no capital costs or operating and maintenance costs associated with this collection of information. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: BILLING CODE 4160–01–P Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and ‘‘Lookback’’—(OMB Control Number 0910–0116)—Extension DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0511] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and ‘‘Lookback’’ Food and Drug Administration, HHS. Notice. 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 23, 2012. 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 emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0116. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: jlentini on DSK4TPTVN1PROD with NOTICES Average burden per response 1 [FR Doc. 2011–32777 Filed 12–21–11; 8:45 am] ACTION: Total annual responses 180 Dated: December 19, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. AGENCY: Number of responses per respondent Product listing update ................. Total ..................................... 1 There Number of respondents FDA Form 2830 Ila S. Mizrachi, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, (301) 796– 7726, Ila.Mizrachi@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: VerDate Mar<15>2010 19:17 Dec 21, 2011 Jkt 226001 All blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262). Section 351(a) of the PHS Act requires that manufacturers of biological products, which include blood and blood components intended for further manufacture into injectable products, have a license, issued upon a demonstration that the product is safe, pure, and potent and that the manufacturing establishment meets all applicable standards, including those prescribed in the FDA regulations designed to ensure the continued safety, purity, and potency of the product. In addition, under section 361 of the PHS Act (42 U.S.C. 264), by delegation from the Secretary of Health and Human Services, FDA may make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. Section 351(j) of the PHS Act states that the Federal Food, Drug, and Cosmetic Act also applies to biological products. Blood and blood components for transfusion or for further manufacture into injectable products are drugs, as that term is defined in section 201(g)(1) of the Federal, Food, Drug, and Cosmetics Act (21 U.S.C. 321(g)(1)). Because blood and blood components are drugs under the Federal, Food, Drug, and Cosmetics Act, blood and plasma establishments must comply with the substantive provisions and related regulatory scheme of the act. For example, under section 501 of the PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)), drugs are deemed ‘‘adulterated’’ if the methods used in their manufacturing, processing, packing, or holding do not conform to current good manufacturing practice (CGMP) and related regulations. The CGMP regulations in part 606 (21 CFR part 606)) and related regulations implement FDA’s statutory authority to ensure the safety, purity, and potency of blood and blood components. The public health objective in testing human blood donors for evidence of infection due to communicable disease agents and in notifying donors is to prevent the transmission of communicable disease. For example, the ‘‘lookback’’ requirements are intended to help ensure the continued safety of the blood supply by providing necessary information to users of blood and blood components and appropriate notification of recipients of transfusion who are at increased risk for transmitting human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection. The information collection requirements in the CGMP, donor testing, donor notification, and ‘‘lookback’’ regulations provide FDA with the necessary information to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections. The recordkeeping requirements serve preventive and remedial purposes. The disclosure requirements identify the various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing of a product back to its original source. The reporting requirements inform FDA of certain information that may require immediate corrective action. Under the reporting requirements, § 606.170(b), in brief, requires that facilities notify FDA’s Center for Biologics Evaluation and Research E:\FR\FM\22DEN1.SGM 22DEN1

Agencies

[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Pages 79691-79692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32777]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0508]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Blood Establishment 
Registration and Product Listing, Food and Drug Administration Form 
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 
23, 2012.

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 emailed 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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, (301) 796-7726, Ila.Mizrachi@fda.hhs.gov.

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, FDA Form 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, owners or operators of all 
establishments so engaged must register annually between November 15 
and December 31 and must update their blood product listing information 
every June and December. Section 607.22 requires the use of FDA Form 
2830 (Blood Establishment Registration and Product Listing) for initial 
registration, subsequent annual registration, and for blood product 
listing information. Section 607.25 sets forth 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 an amendment to establishment registration within 5 days of 
such changes. Section 607.30(a), in brief, sets forth the information 
required from owners or operators of establishments when updating 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 comply with the establishment 
registration and blood product listing information requirements 
discussed earlier in this document and to provide the name and address 
of the establishment and the name of the individual responsible for 
submitting establishment registration and 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. FDA Form 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.
    In the Federal Register of August 8, 2011 (76 FR 48167), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Number of       Total       Average
                 21 CFR Section                             FDA Form 2830               Number of     responses per     annual     burden per    Total
                                                                                       respondents     respondent     responses     response     hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
607.20(a), 607.21, 607.22, 607.25, and 607.40..  Initial registration..............              49               1           49            1         49
607.21, 607.22, 607.25, 607.26, 607.31, and      Re-registration...................           2,589               1        2,589          0.5      1,295
 607.40.                                                                                                                            (30 min.)

[[Page 79692]]

 
607.21, 607.25, 607.30(a), 607.31, and 607.40..  Product listing update............             180               1          180         0.25         45
                                                                                                                                    (15 min.)
                                                                                    --------------------------------------------------------------------
    Total......................................  ..................................  ..............  ..............  ...........  ...........      1,389
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: December 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32777 Filed 12-21-11; 8:45 am]
BILLING CODE 4160-01-P
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