Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies, 19054-19056 [2017-08304]

Download as PDF 19054 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents 21 CFR section Number of responses per respondent Total annual responses Average burden per response Total hours 361.1(c)(8); adverse events ................................................. 10 1 10 0.5 5 Total .............................................................................. ........................ ........................ 569 ........................ 1,789 1 There are no capital or operating and maintenance costs associated with the information collection. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section; FDA form Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 361.1(c)(2) ............................................................................ 361.1(d)(5) ........................................................................... 69 35 4 14 276 490 10 0.75 2,760 368 Total .............................................................................. ........................ ........................ 766 ........................ 3,128 1 There are no capital or operating and maintenance costs associated with the information collection. Dated: April 19, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. ADDRESSES: [FR Doc. 2017–08300 Filed 4–24–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0075] Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies 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 (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 provisions of FDA’s good laboratory practice (GLP) regulations for nonclinical laboratory studies. asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: Submit either electronic or written comments on the collection of information by June 26, 2017. DATES: VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov/. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 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 https://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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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– 2011–N–0075 for ‘‘Good Laboratory Practice Regulations for Nonclinical Studies.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 https://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’’ E:\FR\FM\25APN1.SGM 25APN1 19055 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 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: https://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 https:// 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: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Good Laboratory Practice Regulations for Nonclinical Studies—21 CFR Part 58 OMB Control Number 0910–0119— Extension Sections 409, 505, 512, and 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348, 355, 360b, and 360e) and related statutes require manufacturers of food additives, human drugs and biological products, animal drugs, and medical devices to demonstrate the safety and utility of their product by submitting applications to FDA for research or marketing permits. Such applications contain, among other important items, full reports of all studies done to demonstrate product safety in man and/or other animals. In order to ensure adequate quality control for these studies and to provide an adequate degree of consumer protection, the Agency issued GLP regulations for nonclinical laboratory studies in part 58 (21 CFR part 58). The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures (SOPs), test and control articles, quality assurance, protocol and conduct of a safety study, records and reports, and laboratory disqualification. Part 58 requires testing facilities engaged in conducting toxicological studies to retain, and make available to regulatory officials, records regarding compliance with GLPs. Records are maintained on file at each testing facility and examined there periodically by FDA inspectors. The GLP regulations require that, for each nonclinical laboratory study, a final report be prepared that documents the results of quality assurance unit inspections, test and control article characterization, testing of mixtures of test and control articles with carriers, and an overall interpretation of nonclinical laboratory studies. The GLP regulations also require written records pertaining to: (1) Personnel job descriptions and summaries of training and experience; (2) master schedules, protocols and amendments thereto, inspection reports, and SOPs; (3) equipment inspection, maintenance, calibration, and testing records; (4) documentation of feed and water analyses, and animal treatments; (5) test article accountability records; and (6) study documentation and raw data. Recordkeeping is necessary to document the conduct of nonclinical laboratory studies of FDA-regulated products to ensure the quality and integrity of the resulting final study report on which a regulatory decision may be based. Written SOPs and records of actions taken are essential for testing facilities to implement GLP’s effectively. Further, they are essential for FDA to be able to determine a testing facility’s compliance with the GLP regulations in part 58. In a notice of proposed rulemaking published in the Federal Register of August 24, 2016 (81 FR 58342), we proposed changes in our GLP regulations, including some of those listed in tables 1 and 2 of this document. The document included revised burden estimates for the proposed changes and solicited public comment. In response to requests, the comment period was extended to January 21, 2017 (81 FR 75351, October 31, 2016). In the interim, FDA is seeking an extension of OMB approval for the current regulations so that we can continue to collect information while the proposal is pending. Description of Respondents: The likely respondents collecting this information are contract laboratories, sponsors of FDA-regulated products, universities, or government agencies. FDA estimates the burden of this collection of information as follows: asabaliauskas on DSK3SPTVN1PROD with NOTICES TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR section 58.35(b)(7); Quality assurance unit ..................................... 58.185; Reporting of nonclinical laboratory study results ... VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00040 Number of responses per respondent 300 300 Fmt 4703 Sfmt 4703 Total annual responses 60.25 60.25 E:\FR\FM\25APN1.SGM 18,075 18,075 25APN1 Average burden per response 1 27.65 Total hours 18,075 499,774 19056 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents Number of responses per respondent Total annual responses Average burden per response ........................ ........................ ........................ ........................ 21 CFR section Total .............................................................................. 1 There Total hours 517,849 are no capital costs or operating maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section Number of records per recordkeeper Average burden per recordkeeping (in hours) Total annual records Total hours 58.29(b); Personnel .............................................. 58.35(b)(1)–(6), and (c); Quality assurance unit .. 58.63(b) and (c); Maintenance and calibration of equipment. 58.81(a)–(c); SOPs ............................................... 58.90(c) and (g); Animal care .............................. 58.105(a) and (b); Test and control article characterization. 58.107(d); Test and control article handling ........ 58.113(a); Mixtures of articles with carriers ......... 58.120; Protocol ................................................... 58.195; Retention of records ................................ 300 300 300 20 270.76 60 6,000 81,228 18,000 0.21 (13 minutes) ......... 3.36 ............................... 0.09 (5 minutes) ........... 1,260 272,926 1,620 300 300 300 301.8 62.7 5 90,540 18,810 1,500 0.14 (8 minutes) ........... 0.13 (8 minutes) ........... 11.8 ............................... 12,676 2,445 17,700 300 300 300 300 1 15.33 15.38 251.5 300 4,599 4,614 75,450 4.25 ............................... 6.8 ................................. 32.7 ............................... 3.9 ................................. 1,275 31,273 150,878 294,255 Total ............................................................... ........................ ........................ ........................ ....................................... 786,308 1There are no capital costs or operating and maintenance costs associated with this collection of information. The annual burden for the information collection requirements in these regulations is estimated at 1,304,157 burden hours (517,849 plus 786,308 equals 1,304,157). The hours per response estimates are based on our experience with similar programs and information received from industry. Dated: April 19, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–08304 Filed 4–24–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration asabaliauskas on DSK3SPTVN1PROD with NOTICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under SUMMARY: VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 Fax written comments on the collection of information by May 25, 2017. DATES: 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 0910–0130. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: For specific questions for FDA related to this document, contact JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301– 796–3794. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2013–N–1163] AGENCY: the Paperwork Reduction Act of 1995 (PRA). Institutional Review Boards—21 CFR 56.115—OMB Control Number 0910– 0130—Extension When reviewing clinical research studies regulated by FDA, institutional review boards (IRBs) are required to create and maintain records describing their operations, and make the records PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 available for FDA inspection when requested. These records include: Written procedures describing the structure and membership of the IRB and the methods that the IRB will use in performing its functions; the research protocols, informed consent documents, progress reports, and reports of injuries to subjects submitted by investigators to the IRB; minutes of meetings showing attendance, votes, and decisions made by the IRB, the number of votes on each decision for, against, and abstaining; the basis for requiring changes in or disapproving research; records of continuing review activities; copies of all correspondence between investigators and the IRB; statement of significant new findings provided to subjects of the research; and a list of IRB members by name, showing each member’s earned degrees, representative capacity, and experience in sufficient detail to describe each member’s contributions to the IRB’s deliberations; and any employment relationship between each member and the IRB’s institution. This information is used by FDA in conducting audit inspections of IRBs to determine whether IRBs and clinical investigators are providing adequate protections to human subjects participating in clinical research. The recordkeeping requirement burden is based on the following: The burden for the paragraphs under 21 CFR 56.115 has been considered as one E:\FR\FM\25APN1.SGM 25APN1

Agencies

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19054-19056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08304]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0075]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Good Laboratory Practice Regulations for Nonclinical
Studies

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
(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 provisions of
FDA's good laboratory practice (GLP) regulations for nonclinical
laboratory studies.

DATES: Submit either electronic or written comments on the collection
of information by June 26, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov/.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 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 https://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-2011-N-0075 for ``Good Laboratory Practice Regulations for
Nonclinical Studies.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://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 https://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''

[[Page 19055]]

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: https://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 https://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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Good Laboratory Practice Regulations for Nonclinical Studies--21 CFR
Part 58

OMB Control Number 0910-0119--Extension

Sections 409, 505, 512, and 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 348, 355, 360b, and 360e) and related statutes
require manufacturers of food additives, human drugs and biological
products, animal drugs, and medical devices to demonstrate the safety
and utility of their product by submitting applications to FDA for
research or marketing permits. Such applications contain, among other
important items, full reports of all studies done to demonstrate
product safety in man and/or other animals. In order to ensure adequate
quality control for these studies and to provide an adequate degree of
consumer protection, the Agency issued GLP regulations for nonclinical
laboratory studies in part 58 (21 CFR part 58). The regulations specify
minimum standards for the proper conduct of safety testing and contain
sections on facilities, personnel, equipment, standard operating
procedures (SOPs), test and control articles, quality assurance,
protocol and conduct of a safety study, records and reports, and
laboratory disqualification.
Part 58 requires testing facilities engaged in conducting
toxicological studies to retain, and make available to regulatory
officials, records regarding compliance with GLPs. Records are
maintained on file at each testing facility and examined there
periodically by FDA inspectors. The GLP regulations require that, for
each nonclinical laboratory study, a final report be prepared that
documents the results of quality assurance unit inspections, test and
control article characterization, testing of mixtures of test and
control articles with carriers, and an overall interpretation of
nonclinical laboratory studies. The GLP regulations also require
written records pertaining to: (1) Personnel job descriptions and
summaries of training and experience; (2) master schedules, protocols
and amendments thereto, inspection reports, and SOPs; (3) equipment
inspection, maintenance, calibration, and testing records; (4)
documentation of feed and water analyses, and animal treatments; (5)
test article accountability records; and (6) study documentation and
raw data.
Recordkeeping is necessary to document the conduct of nonclinical
laboratory studies of FDA-regulated products to ensure the quality and
integrity of the resulting final study report on which a regulatory
decision may be based. Written SOPs and records of actions taken are
essential for testing facilities to implement GLP's effectively.
Further, they are essential for FDA to be able to determine a testing
facility's compliance with the GLP regulations in part 58.
In a notice of proposed rulemaking published in the Federal
Register of August 24, 2016 (81 FR 58342), we proposed changes in our
GLP regulations, including some of those listed in tables 1 and 2 of
this document. The document included revised burden estimates for the
proposed changes and solicited public comment. In response to requests,
the comment period was extended to January 21, 2017 (81 FR 75351,
October 31, 2016). In the interim, FDA is seeking an extension of OMB
approval for the current regulations so that we can continue to collect
information while the proposal is pending.
Description of Respondents: The likely respondents collecting this
information are contract laboratories, sponsors of FDA-regulated
products, universities, or government agencies.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
58.35(b)(7); Quality assurance 300 60.25 18,075 1 18,075
unit...........................
58.185; Reporting of nonclinical 300 60.25 18,075 27.65 499,774
laboratory study results.......
-------------------------------------------------------------------------------

[[Page 19056]]

Total....................... .............. .............. .............. .............. 517,849
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating maintenance costs associated with this collection of information.

Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
21 CFR Section recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
58.29(b); Personnel........... 300 20 6,000 0.21 (13 1,260
minutes).
58.35(b)(1)-(6), and (c); 300 270.76 81,228 3.36............ 272,926
Quality assurance unit.
58.63(b) and (c); Maintenance 300 60 18,000 0.09 (5 minutes) 1,620
and calibration of equipment.
58.81(a)-(c); SOPs............ 300 301.8 90,540 0.14 (8 minutes) 12,676
58.90(c) and (g); Animal care. 300 62.7 18,810 0.13 (8 minutes) 2,445
58.105(a) and (b); Test and 300 5 1,500 11.8............ 17,700
control article
characterization.
58.107(d); Test and control 300 1 300 4.25............ 1,275
article handling.
58.113(a); Mixtures of 300 15.33 4,599 6.8............. 31,273
articles with carriers.
58.120; Protocol.............. 300 15.38 4,614 32.7............ 150,878
58.195; Retention of records.. 300 251.5 75,450 3.9............. 294,255
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 786,308
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

The annual burden for the information collection requirements in
these regulations is estimated at 1,304,157 burden hours (517,849 plus
786,308 equals 1,304,157). The hours per response estimates are based
on our experience with similar programs and information received from
industry.

Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08304 Filed 4-24-17; 8:45 am]
BILLING CODE 4164-01-P

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