Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, 46838-46839 [2014-18945]

Download as PDF 46838 Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1069] Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 on Form FDA 2830. DATES: Submit electronic or written comments on the collection of information by October 10, 2014. 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. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. 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. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:35 Aug 08, 2014 Jkt 232001 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 his or her name, place of business, and all such establishments with the Secretary of Health and Human Services on or before December 31 of each year. He or she must also 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 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 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 update their blood product listing every June and December. Section 607.22 requires the use of Form FDA 2830, Blood Establishment Registration and Product Listing, for initial registration, for 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 the 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 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. E:\FR\FM\11AUN1.SGM 11AUN1 Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices 46839 FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section Form FDA 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. 607.21, 607.25, 607.30(a), 607.31, and 607.40. Initial Registration. Re-registration. Product Updating List. Total .................................................... 1 There ...................... Dated: August 5, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–18945 Filed 8–8–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1081] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability Food and Drug Administration, HHS. ACTION: Notice. 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 guidance which discusses FDA’s approach to enforcement of adverse event reporting requirements during an influenza pandemic. SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES Number of responses per respondent Total annual responses 68 1 68 2,615 1 2,615 166 1 166 ........................ ........................ ........................ Average burden per response Total hours 1 .................... 68 0.5 (30 minutes). 0.25 (15 minutes). 1,308 ....................... 1,418 42 are no capital costs of operating and maintenance costs associated with this collection of information. 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. AGENCY: Number of respondents VerDate Mar<15>2010 17:35 Aug 08, 2014 Jkt 232001 Submit either electronic or written comments on the collection of information by October 10, 2014. 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. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. 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. 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 (OMB Control Number 0910–0701)— Extension DATES: SUPPLEMENTARY INFORMATION: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability The guidance includes recommendations for planning, notification, and documentation for firms that report postmarketing adverse events. The guidance recommends that each firm’s pandemic influenza continuity of operations plan (COOP) include instructions for reporting adverse events, including a plan for the submission of stored reports that were not submitted within regulatory timeframes. The guidance explains that firms that are unable to fulfill normal adverse event reporting requirements during an influenza pandemic should: (1) Maintain documentation of the conditions that prevent them from meeting normal reporting requirements; (2) notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions exist and when the reporting process is restored; and (3) maintain records to identify what reports have been stored. E:\FR\FM\11AUN1.SGM 11AUN1

Agencies

[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46838-46839]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18945]



[[Page 46838]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1069]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Blood Establishment Registration and Product Listing

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 on Form 
FDA 2830.

DATES: Submit electronic or written comments on the collection of 
information by October 10, 2014.

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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 his or her name, place of business, and all such 
establishments with the Secretary of Health and Human Services on or 
before December 31 of each year. He or she must also 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 
update their blood product listing every June and December.
    Section 607.22 requires the use of Form FDA 2830, Blood 
Establishment Registration and Product Listing, for initial 
registration, for 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 the 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 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.

[[Page 46839]]

    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Number of
            21 CFR section                   Form FDA 2830          Number of     responses per   Total annual     Average  burden per      Total hours
                                                                   respondents     respondent       responses            response
--------------------------------------------------------------------------------------------------------------------------------------------------------
607.20(a), 607.21, 607.22, 607.25,     Initial Registration....              68               1              68  1......................              68
 and 607.40.
607.21, 607.22, 607.25, 607.26,        Re-registration.........           2,615               1           2,615  0.5 (30 minutes).......           1,308
 607.31, and 607.40.
607.21, 607.25, 607.30(a), 607.31,     Product Updating List...             166               1             166  0.25 (15 minutes)......              42
 and 607.40.
                                                                ----------------------------------------------------------------------------------------
    Total............................  ........................  ..............  ..............  ..............  .......................           1,418
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs of operating and maintenance costs associated with this collection of information.

    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.

    Dated: August 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18945 Filed 8-8-14; 8:45 am]
BILLING CODE 4164-01-P