81 FR 36550 - Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing; Forms FDA 3486 and 3486A
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 109 (June 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 109 (June 7, 2016)
| Page Range | 36550-36552 | |
| FR Document | 2016-13366 |
[Federal Register Volume 81, Number 109 (Tuesday, June 7, 2016)] [Notices] [Pages 36550-36552] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13366] ----------------------------------------------------------------------- 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 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 8, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your [[Page 36551]] comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-N-0579 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing; Forms FDA 3486 and 3486A.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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. 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, section 501 of 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 [[Page 36552]] 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: (1) Licensed manufacturers of biological products other than human blood and blood components, (2) licensed manufacturers of blood and blood components including Source Plasma, (3) unlicensed registered blood establishments, (4) transfusion services, and (5) 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 2015. 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, which includes a minimal one- time burden to create a user account for those reports submitted electronically. 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 a Web-based addendum to Form FDA 3486 (Form FDA 3486A) to provide 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, Form FDA 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 Form FDA 3486A. CBER further estimates that it would take between 10 to 20 minutes to complete Form FDA 3486A. For calculation purposes, CBER is using 15 minutes. Activities such as investigating, changing standard operating procedures or processes, and followup are currently required under 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: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section FDA form No. Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 600.14.................................... 3486 102 5.99 611 2........................... 1,222 606.171................................... 3486 1,738 26.34 45,774 2........................... 91,548 1271.350(b)............................... 3486 97 2.64 256 2........................... 512 Web-based Addendum........................ \2\ 3486A 87 26.31 2,289 .25 (15 minutes)............ 572 ------------------------------------------------------------------------------------------------------------- Total................................. .............. .............. .............. .............. ............................ 93,854 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 (1,738 x 0.05 = 87) and total annual responses to CBER (45,774 x 0.05 = 2,289). Dated: May 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-13366 Filed 6-6-16; 8:45 am] BILLING CODE 4164-01-P
![36550 Federal Register / Vol. 81, No. 109 / Tuesday, June 7, 2016 / Notices
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Refugee Microenterprise Development ........................................................... 22 8 4 704
Refugee Home-Based Child Care Microenterprise Development ................... 23 7 4 644
Total Burden ............................................................................................. ........................ ........................ ........................ 1340
Estimated Total Annual Burden which captures and stores the data DEPARTMENT OF HEALTH AND
Hours: (1340 hours x $30 per hour) required for reporting. The grantee HUMAN SERVICES
$40,440 per year. uploads the data required in Grant
Solution where it is stored. ORR derives Food and Drug Administration
Explanation
the data it requires for reporting and [Docket No. FDA–2013–N–0579]
The Refugee Microenterprise management decision from Grant
Development Program Solution. Agency Information Collection
• Currently, there are twenty two Activities; Proposed Collection;
Additional Information Comment Request; Biological
grantees (respondents) in the program
and the semi-annual progress, which Copies of the proposed collection may Products: Reporting of Biological
includes the data and information be obtained by writing to the Product Deviations and Human Cells,
required, is submitted twice per year. Tissues, and Cellular and Tissue-
Administration for Children and
• The request covers one form (Form Families, Office of Planning, Research
Based Deviations in Manufacturing;
I. attached) which includes eight data Forms FDA 3486 and 3486A
and Evaluation, 370 L’Enfant
points. Based on experience (the
Promenade SW., Washington, DC 20447, AGENCY: Food and Drug Administration,
information was provided by technical
Attn: ACF Reports Clearance Officer. All HHS.
assistance service provider in the past),
it takes about two hours per respondent requests should be identified by the title ACTION: Notice.
per six months (i.e., four hours per year of the information collection. Email
address: infocollection@acf.hhs.gov. SUMMARY: The Food and Drug
per grantee (respondent) or 88 hours per Administration (FDA) is announcing an
year for all respondents) to complete the OMB Comment opportunity for public comment on the
form. proposed collection of certain
• No survey will be undertaken since OMB is required to make a decision information by the Agency. Under the
the collection of this data (information) concerning the collection of information Paperwork Reduction Act of 1995 (the
is part of the implementation process of between 30 and 60 days after PRA), Federal Agencies are required to
the project and its collection and publication of this document in the publish notice in the Federal Register
reporting does not constitute a separate Federal Register. Therefore, a comment concerning each proposed collection of
and additional cost to the grantees is best assured of having its full effect information, including each proposed
(respondents). The cost is covered by if OMB receives it within 30 days of extension of an existing collection of
the grant the grantee receives. The publication. Written comments and information, and to allow 60 days for
grantees have Down Home database recommendations for the proposed public comment in response to the
which captures and stores the data information collection should be sent notice. This notice solicits comments on
required for reporting. The grantee the information collection requirements
directly to the following: Office of
uploads the semi-annual report in Grant relating to the reporting of biological
Management and Budget, Paperwork
Solution where it is stored. ORR derives product deviations in manufacturing
the data it requires for reporting and Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn: and human cells, tissues, and cellular
management decision from Grant and tissue-based product (HCT/P)
Solution. Desk Officer for the Administration for
Children and Families. deviations, and Forms FDA 3486 and
The Refugee Home-Based Child Care 3486A.
Microenterprise Development Group Robert Sargis,
DATES: Submit electronic or written
• Currently, there are twenty three Reports Clearance Officer. comments on the collection of
grantees (respondents) in the program [FR Doc. 2016–13401 Filed 6–6–16; 8:45 am] information by August 8, 2016.
and the semi-annual progress. BILLING CODE 4184–01–P ADDRESSES: You may submit comments
• The request covers one form (Form as follows:
II. attached) which includes seven data
points. It takes about two hours per Electronic Submissions
respondent per six months (i.e., four Submit electronic comments in the
hours per year grantee (respondent) or following way:
92 hours per year for all respondents) to • Federal eRulemaking Portal: http://
asabaliauskas on DSK3SPTVN1PROD with NOTICES
complete the form. www.regulations.gov. Follow the
• The collection of this data instructions for submitting comments.
(information) is part of the process and Comments submitted electronically,
its collection and reporting does not including attachments, to http://
include separate and additional cost to www.regulations.gov will be posted to
the grantees (respondents). The cost is the docket unchanged. Because your
covered by the grant the grantee comment will be made public, you are
receives. The grantees have database solely responsible for ensuring that your
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![36552 Federal Register / Vol. 81, No. 109 / Tuesday, June 7, 2016 / Notices
holds the biological product license, for manufacturers of biological products pattern; (2) method of consignee
other than human blood and blood other than human blood and blood notification; (3) consignee(s) of products
components, and who had control over components, (2) licensed manufacturers for further manufacture; (4) additional
a distributed product when the of blood and blood components product information; (5) updated
deviation occurred, to report to the including Source Plasma, (3) unlicensed product disposition; and (6) industry
Center for Biologics Evaluation and registered blood establishments, (4) recall contacts. This information is
Research (CBER) or to the Center for transfusion services, and (5) requested by CBER through email
Drugs Evaluation and Research (CDER) establishments that manufacture non- notification to the submitter of the BPD
as soon as possible but at a date not to reproductive HCT/Ps regulated solely report. This information is used by
exceed 45 calendar days after acquiring under section 361 of the PHS Act as CBER for recall classification purposes.
information reasonably suggesting that a described in § 1271.10. The number of At this time, Form FDA 3486A is being
reportable event has occurred. Section respondents and total annual responses used only for those BPD reports
606.171, in brief, requires licensed are based on the BPD reports and HCT/
submitted under § 606.171. CBER
manufacturers of human blood and P deviation reports FDA received in
estimates that 5 percent of the total BPD
blood components, including Source fiscal year 2015. The number of licensed
Plasma, unlicensed registered blood manufacturers and total annual reports submitted to CBER under
establishments, and transfusion responses under § 600.14 include the § 606.171 would need additional
services, who had control over a estimates for BPD reports submitted to information submitted in Form FDA
distributed product when the deviation both CBER and CDER. Based on the 3486A. CBER further estimates that it
occurred, to report to CBER as soon as information from industry, the would take between 10 to 20 minutes to
possible but at a date not to exceed 45 estimated average time to complete a complete Form FDA 3486A. For
calendar days after acquiring deviation report is 2 hours, which calculation purposes, CBER is using 15
information reasonably suggesting that a includes a minimal one-time burden to minutes.
reportable event has occurred. create a user account for those reports Activities such as investigating,
Similarly, § 1271.350(b), in brief, submitted electronically. The changing standard operating procedures
requires HCT/P establishments that availability of the standardized report or processes, and followup are currently
manufacture non-reproductive HCT/Ps form, Form FDA 3486, and the ability to required under parts 211 (approved
described in § 1271.10 to investigate and submit this report electronically to under OMB control number 0910–0139),
report to CBER all HCT/P deviations CBER (CDER does not currently accept part 606 (approved under OMB control
relating to a distributed HCT/P that electronic filings) further streamlines number 0910–0116), part 820 (approved
relates to the core CGTP requirements, the report submission process. under OMB control number 0910–0073),
if the deviation occurred in the CBER has developed a Web-based
and part 1271 (approved under OMB
establishment’s facility or in a facility addendum to Form FDA 3486 (Form
control number 0910–0543) and,
that performed a manufacturing step for FDA 3486A) to provide additional
information when a BPD report has been therefore, are not included in the
the establishment under contract,
reviewed by FDA and evaluated as a burden calculation for the separate
agreement, or other arrangement. Form
possible recall. The additional requirement of submitting a deviation
FDA 3486 is used to submit BPD reports
and HCT/P deviation reports. information requested includes report to FDA.
Respondents to this collection of information not contained in the Form FDA estimates the burden of this
information are: (1) Licensed FDA 3486 such as: (1) Distribution collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
FDA Number of Total
21 CFR section responses per annual burden
form No. respondents hours
respondent responses per response
600.14 .......................................... 3486 102 5.99 611 2 ................................ 1,222
606.171 ........................................ 3486 1,738 26.34 45,774 2 ................................ 91,548
1271.350(b) .................................. 3486 97 2.64 256 2 ................................ 512
Web-based Addendum ................ 2 3486A 87 26.31 2,289 .25 (15 minutes) ........ 572
Total ...................................... ........................ ........................ ........................ ........................ .................................... 93,854
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 (1,738 × 0.05 = 87) and total annual responses to CBER (45,774 × 0.05 = 2,289).
Dated: May 26, 2016. DEPARTMENT OF HEALTH AND provisions set forth in sections
Leslie Kux, HUMAN SERVICES 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Associate Commissioner for Policy. as amended. The grant applications and
National Institutes of Health the discussions could disclose
[FR Doc. 2016–13366 Filed 6–6–16; 8:45 am]
confidential trade secrets or commercial
asabaliauskas on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4164–01–P National Institute of Mental Health; property such as patentable material,
Notice of Closed Meetings and personal information concerning
Pursuant to section 10(d) of the individuals associated with the grant
Federal Advisory Committee Act, as applications, the disclosure of which
amended (5 U.S.C. App.), notice is would constitute a clearly unwarranted
hereby given of the following meetings. invasion of personal privacy.
The meetings will be closed to the Name of Committee: National Institute of
public in accordance with the Mental Health Special Emphasis Panel Pilot
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Document Created: 2018-02-08 07:32:03
Document Modified: 2018-02-08 07:32:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit electronic or written comments on the collection of information by August 8, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 36550 |
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