Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A, 33846-33847 [2013-13279]

Download as PDF 33846 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices Dated: May 30, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–13247 Filed 6–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0579] Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and TissueBased Product Deviations in Manufacturing; Forms FDA 3486 and 3486A 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 reporting of biological product deviations in manufacturing and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations, and Forms FDA 3486 and 3486A. Submit electronic or written comments on the collection of information by August 5, 2013. ADDRESSES: Submit electronic comments on the collection of information to: https:// 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: Ila Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– mstockstill on DSK4VPTVN1PROD with NOTICES DATES: VerDate Mar<15>2010 16:43 Jun 04, 2013 Jkt 229001 400B, Rockville, MD 20850, 301–796– 7726, Ila.Mizrachi@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. Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A (OMB Control Number 0910– 0458)—Extension Under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), all biological products, including human blood and blood components, offered for sale in interstate commerce must be licensed and meet standards, including those prescribed in the FDA regulations, designed to ensure the continued safety, purity, and potency of such products. In addition under section 361 of the PHS Act (42 U.S.C. 264), FDA may issue and enforce regulations necessary to prevent the introduction, transmission, or spread of PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 communicable diseases between the States or possessions or from foreign countries into the States or possessions. Further, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351) provides that drugs and devices (including human blood and blood components) are adulterated if they do not conform with current good manufacturing practice (CGMP) assuring that they meet the requirements of the FD&C Act. Establishments manufacturing biological products, including human blood and blood components, must comply with the applicable CGMP regulations (parts 211, 606, and 820 (21 CFR parts 211, 606, and 820)) and current good tissue practice (CGTP) regulations (part 1271 (21 CFR part 1271)) as appropriate. FDA regards biological product deviation (BPD) reporting and HCT/P deviation reporting to be an essential tool in its directive to protect public health by establishing and maintaining surveillance programs that provide timely and useful information. Section 600.14 (21 CFR 600.14), in brief, requires the manufacturer who holds the biological product license, for other than human blood and blood components, and who had control over a distributed product when the deviation occurred, to report to the Center for Biologics Evaluation and Research (CBER) or to the Center for Drugs Evaluation and Research (CDER) as soon as possible but at a date not to exceed 45 calendar days after acquiring information reasonably suggesting that a reportable event has occurred. Section 606.171, in brief, requires licensed manufacturers of human blood and blood components, including Source Plasma, unlicensed registered blood establishments, and transfusion services, who had control over a distributed product when the deviation occurred, to report to CBER as soon as possible but at a date not to exceed 45 calendar days after acquiring information reasonably suggesting that a reportable event has occurred. Similarly, § 1271.350(b), in brief, requires HCT/P establishments that manufacture non-reproductive HCT/Ps described in § 1271.10 to investigate and report to CBER all HCT/P deviations relating to a distributed HCT/P that relates to the core CGTP requirements, if the deviation occurred in the establishment’s facility or in a facility that performed a manufacturing step for the establishment under contract, agreement or other arrangement. Form FDA 3486 is used to submit BPD reports and HCT/P deviation reports. Respondents to this collection of information are the licensed E:\FR\FM\05JNN1.SGM 05JNN1 33847 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices manufacturers of biological products other than human blood and blood components, licensed manufacturers of blood and blood components including Source Plasma, unlicensed registered blood establishments, transfusion services, and establishments that manufacture non-reproductive HCT/Ps regulated solely under section 361 of the PHS Act as described in § 1271.10. The number of respondents and total annual responses are based on the BPD reports and HCT/P deviation reports FDA received in fiscal year 2012. The number of licensed manufacturers and total annual responses under § 600.14 include the estimates for BPD reports submitted to both CBER and CDER. Based on the information from industry, the estimated average time to complete a deviation report is 2 hours. The availability of the standardized report form, Form FDA 3486, and the ability to submit this report electronically to CBER (CDER does not currently accept electronic filings) further streamlines the report submission process. CBER has developed an addendum to Form FDA 3486. The Web-based addendum (Form FDA 3486A) provides additional information when a BPD report has been reviewed by FDA and evaluated as a possible recall. The additional information requested includes information not contained in the Form FDA 3486 such as: (1) Distribution pattern; (2) method of consignee notification; (3) consignee(s) of products for further manufacture; (4) additional product information; (5) updated product disposition; and (6) industry recall contacts. This information is requested by CBER through email notification to the submitter of the BPD report. This information is used by CBER for recall classification purposes. At this time, Addendum 3486A is being used only for those BPD reports submitted under § 606.171. CBER estimates that 5 percent of the total BPD reports submitted to CBER under § 606.171 would need additional information submitted in the addendum. CBER further estimates that it would take between 10 to 20 minutes to complete the addendum. For calculation purposes, CBER is using 15 minutes. Activities such as investigating, changing standard operating procedures or processes, and followup are currently required under 21 CFR parts 211, (approved under OMB control number 0910–0139), part 606 (approved under OMB control number 0910–0116), part 820 (approved under OMB control number 0910–0073) and part 1271 (approved under OMB control number 0910–0543) and, therefore, are not included in the burden calculation for the separate requirement of submitting a deviation report to FDA. FDA estimates the burden of this collection of information as follows: ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR section Form FDA No. Number of responses per respondent Number of respondents Average burden per response Total annual responses Total hours 600.14 .................................................... 606.171 .................................................. 1271.350(b) ............................................ 3486 3486 3486 2 3486A 91 1,679 94 84 7.71 32.73 2.66 32.70 702 54,954 250 2,747 2.0 2.0 2.0 0.25 1,404 109,908 500 687 Total ................................................ ........................ ........................ ........................ ........................ .......................... 112,499 1 There 2 Five are no capital costs or operating and maintenance costs associated with this collection of information. percent of the number of respondents (1,679 × 0.05 = 84) and total annual responses to CBER (54,954 × 0.05 = 2,748). Dated: May 30, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–13279 Filed 6–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0172] mstockstill on DSK4VPTVN1PROD with NOTICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application 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 VerDate Mar<15>2010 16:43 Jun 04, 2013 Jkt 229001 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 5, 2013. 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 0910–0622. 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 has submitted the following proposed collection of information to OMB for review and clearance. Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application—(OMB Control Number 0910–0622)—Reinstatement Under § 312.120 (21 CFR 312.120), FDA accepts foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or application for marketing approval for a drug or biological product if the studies are conducted in accordance with good clinical practices (GCP), including review and approval by an independent ethics committee (IEC). Under § 312.120(a), FDA accepts as support for an IND or application for marketing approval a well-designed and well-conducted foreign clinical study not conducted under an IND if the study is conducted in accordance with GCP, and we are able to validate the data from the study through an onsite inspection if necessary. GCP includes review and E:\FR\FM\05JNN1.SGM 05JNN1

Agencies

[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33846-33847]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13279]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0579]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Biological Products: Reporting of Biological Product
Deviations and Human Cells, Tissues, and Cellular and Tissue-Based
Product Deviations in Manufacturing; Forms FDA 3486 and 3486A

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 reporting of biological product deviations
in manufacturing and human cells, tissues, and cellular and tissue-
based product (HCT/P) deviations, and Forms FDA 3486 and 3486A.

DATES: Submit electronic or written comments on the collection of
information by August 5, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to: https://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: Ila 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: 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.

Biological Products: Reporting of Biological Product Deviations and
Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations
in Manufacturing; Forms FDA 3486 and 3486A (OMB Control Number 0910-
0458)--Extension

Under section 351 of the Public Health Service Act (PHS Act) (42
U.S.C. 262), all biological products, including human blood and blood
components, offered for sale in interstate commerce must be licensed
and meet standards, including those prescribed in the FDA regulations,
designed to ensure the continued safety, purity, and potency of such
products. In addition under section 361 of the PHS Act (42 U.S.C. 264),
FDA may issue and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases between
the States or possessions or from foreign countries into the States or
possessions. Further, the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 351) provides that drugs and devices (including
human blood and blood components) are adulterated if they do not
conform with current good manufacturing practice (CGMP) assuring that
they meet the requirements of the FD&C Act. Establishments
manufacturing biological products, including human blood and blood
components, must comply with the applicable CGMP regulations (parts
211, 606, and 820 (21 CFR parts 211, 606, and 820)) and current good
tissue practice (CGTP) regulations (part 1271 (21 CFR part 1271)) as
appropriate. FDA regards biological product deviation (BPD) reporting
and HCT/P deviation reporting to be an essential tool in its directive
to protect public health by establishing and maintaining surveillance
programs that provide timely and useful information.
Section 600.14 (21 CFR 600.14), in brief, requires the manufacturer
who holds the biological product license, for other than human blood
and blood components, and who had control over a distributed product
when the deviation occurred, to report to the Center for Biologics
Evaluation and Research (CBER) or to the Center for Drugs Evaluation
and Research (CDER) as soon as possible but at a date not to exceed 45
calendar days after acquiring information reasonably suggesting that a
reportable event has occurred. Section 606.171, in brief, requires
licensed manufacturers of human blood and blood components, including
Source Plasma, unlicensed registered blood establishments, and
transfusion services, who had control over a distributed product when
the deviation occurred, to report to CBER as soon as possible but at a
date not to exceed 45 calendar days after acquiring information
reasonably suggesting that a reportable event has occurred. Similarly,
Sec. 1271.350(b), in brief, requires HCT/P establishments that
manufacture non-reproductive HCT/Ps described in Sec. 1271.10 to
investigate and report to CBER all HCT/P deviations relating to a
distributed HCT/P that relates to the core CGTP requirements, if the
deviation occurred in the establishment's facility or in a facility
that performed a manufacturing step for the establishment under
contract, agreement or other arrangement. Form FDA 3486 is used to
submit BPD reports and HCT/P deviation reports.
Respondents to this collection of information are the licensed

[[Page 33847]]

manufacturers of biological products other than human blood and blood
components, licensed manufacturers of blood and blood components
including Source Plasma, unlicensed registered blood establishments,
transfusion services, and establishments that manufacture non-
reproductive HCT/Ps regulated solely under section 361 of the PHS Act
as described in Sec. 1271.10. The number of respondents and total
annual responses are based on the BPD reports and HCT/P deviation
reports FDA received in fiscal year 2012. The number of licensed
manufacturers and total annual responses under Sec. 600.14 include the
estimates for BPD reports submitted to both CBER and CDER. Based on the
information from industry, the estimated average time to complete a
deviation report is 2 hours. The availability of the standardized
report form, Form FDA 3486, and the ability to submit this report
electronically to CBER (CDER does not currently accept electronic
filings) further streamlines the report submission process.
CBER has developed an addendum to Form FDA 3486. The Web-based
addendum (Form FDA 3486A) provides additional information when a BPD
report has been reviewed by FDA and evaluated as a possible recall. The
additional information requested includes information not contained in
the Form FDA 3486 such as: (1) Distribution pattern; (2) method of
consignee notification; (3) consignee(s) of products for further
manufacture; (4) additional product information; (5) updated product
disposition; and (6) industry recall contacts. This information is
requested by CBER through email notification to the submitter of the
BPD report. This information is used by CBER for recall classification
purposes. At this time, Addendum 3486A is being used only for those BPD
reports submitted under Sec. 606.171. CBER estimates that 5 percent of
the total BPD reports submitted to CBER under Sec. 606.171 would need
additional information submitted in the addendum. CBER further
estimates that it would take between 10 to 20 minutes to complete the
addendum. For calculation purposes, CBER is using 15 minutes.
Activities such as investigating, changing standard operating
procedures or processes, and followup are currently required under 21
CFR parts 211, (approved under OMB control number 0910-0139), part 606
(approved under OMB control number 0910-0116), part 820 (approved under
OMB control number 0910-0073) and part 1271 (approved under OMB control
number 0910-0543) and, therefore, are not included in the burden
calculation for the separate requirement of submitting a deviation
report to FDA.
FDA estimates the burden of this collection of information as
follows:

Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Form FDA No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.14.................................................. 3486 91 7.71 702 2.0 1,404
606.171................................................. 3486 1,679 32.73 54,954 2.0 109,908
1271.350(b)............................................. 3486 94 2.66 250 2.0 500
\2\ 3486A 84 32.70 2,747 0.25 687
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. .............. 112,499
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Five percent of the number of respondents (1,679 x 0.05 = 84) and total annual responses to CBER (54,954 x 0.05 = 2,748).

Dated: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13279 Filed 6-4-13; 8:45 am]
BILLING CODE 4160-01-P

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