Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications, 28057-28059 [2019-12703]
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Federal Register / Vol. 84, No. 116 / Monday, June 17, 2019 / Notices
materials must be publicly available or
able to be made public.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2019–12636 Filed 6–14–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Center for State, Tribal, Local and
Territorial Support (CSTLTS), CDC/
ATSDR Tribal Advisory Committee
(TAC) Meeting and 19th Biannual Tribal
Consultation Session
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Centers for Disease
Control and Prevention (CDC)/Agency
for Toxic Substances and Disease
Registry (ATSDR), announces the
following meeting and Tribal
Consultation Session. The meetings are
being hosted by CDC/ATSDR in-person
only and are open to the public.
Attendees must pre-register for the
event by Friday, July 19, 2019, at the
following link: https://www.cdc.gov/
tribal/consultation-support/tac/
index.html.
SUMMARY:
The meeting will be held on
August 13–14, 2019.
DATES:
August 13, 2019
• 8:00 a.m.–9:30 a.m., EDT—Tribal
Caucus (Open only to elected tribal
officials and by invitation)
• 9:30 a.m.–5:45 p.m., EDT—CDC/
ATSDR TAC Meeting (Open to the
public)
August 14, 2019
• 8:00 a.m.–9:30 a.m., EDT—Tribal
Caucus (Open only to elected tribal
officials and by invitation)
• 9:30 a.m.–5:45 p.m., EDT—CDC/
ATSDR TAC Meeting (Open to the
public)
Harrah’s Cherokee, 77
Casino Drive, Cherokee, NC 28719.
FOR FURTHER INFORMATION CONTACT:
Captain Carmen Clelland, PharmD,
MPA, MPH, Director, Office of Tribal
Affairs and Strategic Alliances, Center
for State, Tribal, Local and Territorial
Support, CDC, 4770 Buford Highway,
Mailstop V18–4, Atlanta, GA 30341–
3717; telephone (404) 498–0300;
Tribalsupport@cdc.gov.
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ADDRESSES:
VerDate Sep<11>2014
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This
meeting is being held in accordance
with Presidential Executive Order No.
13175, November 6, 2000, and the
Presidential Memorandum of November
5, 2009, and September 23, 2004,
Consultation and Coordination with
Indian Tribal Governments.
Purpose: The purpose of the TAC and
consultation meetings is to advance
CDC/ATSDR support for and
collaboration with American Indian and
Alaska Native (AI/AN) tribes and to
improve the health of AI/AN tribes by
pursuing goals that include assisting in
eliminating the health disparities faced
by AI/AN tribes; ensuring that access to
critical health and human services and
public health services is maximized to
advance or enhance the social, physical,
and economic status of American Indian
and Alaskan Native people; and
promoting health equity for all Indian
people and communities. To advance
these goals, CDC/ATSDR conducts
government-to-government
consultations with elected tribal
officials or their authorized
representatives. Consultation is an
enhanced form of communication that
emphasizes trust, respect, and shared
responsibility. It is an open and free
exchange of information and opinion
among parties that leads to mutual
understanding.
Matters To Be Considered: The agenda
will include, but not limited to,
discussions on securing sustainable
funding to Indian Country, ensuring a
tribal voice in CDC policy and
programs, and current CDC priorities.
The discussion topics are subject to
revision as prioritize change. The TAC
Meeting and Biannual Tribal
Consultation Session will provide
opportunities for elected AI/AN tribal
officials to speak openly about the
public health issues affecting their tribal
nations. Tribal nations also will have an
opportunity to present testimony about
tribal public health issues. All elected
tribal officials are encouraged to submit
written testimony by 5:00 p.m., EDT,
Friday, July 19, 2019 to Captain Carmen
Clelland, Pharm, MPA, MPH, Director,
Office of Tribal Affairs and Strategic
Alliances via mail to 4770 Buford
Highway, Mailstop V18–4, Atlanta, GA
30341–3717, or by email at
TribalSupport@cdc.gov. Elected tribal
officials can find guidance to assist in
developing tribal testimony for CDC/
ATSDR at www.cdc.gov/tribal/
consultation-support/. Please
submit tribal testimony on official tribal
letterhead.
Based on the number of elected tribal
officials giving testimony and the time
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
28057
available, it may be necessary to limit
the time for each presenter.
Additional information about the
TAC, CDC/ATSDR’s Tribal Consultation
Policy, and previous meetings can be
found at www.cdc.gov/tribal/
consultataion-support/.
Agenda items are subject to change as
priorities dictate.
The Chief Operating Officer, Centers
for Disease Control and Prevention, has
been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–12724 Filed 6–14–19; 8:45 am]
BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0721]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Accreditation of
Third-Party Certification Bodies To
Conduct Food Safety Audits and Issue
Certifications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 17,
2019.
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 0910–0331. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
SUMMARY:
E:\FR\FM\17JNN1.SGM
17JNN1
28058
Federal Register / Vol. 84, No. 116 / Monday, June 17, 2019 / Notices
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Accreditation of Third-Party
Certification Bodies To Conduct Food
Safety Audits and To Issue
Certifications—21 CFR Part 1;
Subpart M
OMB Control Number 0910–0750—
Extension
FDA provides for accreditation of
third-party certification bodies (CBs) to
conduct food safety audits of eligible
foreign food facilities, and issue food
and facility certifications, pursuant to
the FDA Food Safety Modernization
Act. In accordance with 21 CFR part
1.600, subpart M, FDA uses
certifications issued by accredited thirdparty CBs in deciding whether to admit
certain imported food into the United
States that FDA has determined poses a
food safety risk and in deciding whether
an importer is eligible to participate in
a program for expedited review and
entry of food imports. Except for limited
circumstances in which we may directly
accredit CBs to participate in the
accredited third-party audits and
certification program, we will recognize
accreditation bodies (ABs) to accredit
third-party CBs. Use of accredited thirdparty CBs and food and facility
certifications helps us prevent
potentially harmful food from reaching
U.S. consumers and thereby improve
the safety of the U.S. food supply. This
collection of information increases
efficiency by reducing the number of
redundant audits to assess compliance
with applicable food safety
requirements of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) and FDA
regulations.
We estimate that there are about
200,000 foreign food and feed exporters
that offer their food and feed for import
into the United States. These foreign
food and feed exporters include
approximately 130,000 food and feed
production facilities and approximately
71,000 farms. A proportion of these
foreign food and feed exporters may
offer food subject to mandatory
certification requirements under section
801(q) of the FD&C Act (21 U.S.C.
381(q)(3)). In that case, the eligible
entities must either comply with this
collection of information to obtain
certification from a CB accredited under
the third-party program to continue
exporting their food products into the
United States, obtain certification from
a foreign government designated by
FDA, or lose their access to U.S.
markets. We assume that in any given
year, 75 foreign food and feed exporters
will be subject to section 801(q) of the
FD&C Act.
We estimate that 25 ABs will accredit
CBs that will conduct food safety audits
of foreign eligible entities that offer food
or feed for import to the United States.
We also estimate that approximately 207
CBs accredited by the 25 AB applicants
will comply with the collection of
information to participate in the
program. In addition, we expect that one
CB will apply and participate in the
third-party program via direct
accreditation by FDA under this
collection of information.
In the Federal Register of February
20, 2019 (84 FR 5084), we published a
60-day notice requesting public
comment on the proposed collection of
information. Several comments were
submitted, however only those
responsive to the information collection
topics solicited are addressed here.
(Comment 1) One comment suggested
that the Agency should conduct all food
safety audits instead of allowing thirdparty entities to conduct them, which
would allow for greater accountability.
(Response) With current resources, we
do not have the ability to conduct food
safety audits for the thousands of
foreign suppliers that could potentially
be interested in using this program to
establish eligibility for Voluntary
Qualified Importer Program under
section 806 of the FD&C Act (21 U.S.C.
384b) or meet the certification
requirements under section 801(q) of the
FD&C Act. With accredited third-party
CBs and ABs, we can leverage their food
safety activities to benefit our system of
public food safety assurances. The
regulation for accreditation of thirdparty CBs includes requirements for the
accredited CBs to demonstrate their
competence and capability to determine
an eligible entity’s compliance with the
applicable food safety requirements of
the FD&C Act and FDA regulations. In
leveraging private food safety activities,
we can prevent potentially harmful food
from reaching U.S. consumers and
thereby improve the safety of the U.S.
food supply.
(Comment 2) One comment suggested
that there would be less burden for the
public to deal directly with FDA instead
of a third party.
(Response) The Third-Party Program
reduces burden for the public.
Widespread participation and broad
acceptance of audits and certifications
under the program helps increase
efficiency by eliminating redundant
auditing to assess foreign suppliers’
compliance with the FD&C Act and FDA
regulations.
(Comment 3) One comment offered
that the Third-Party Program is a
resourceful and competitive way to
perform food safety audits and issue
certifications.
(Response) We agree with this
comment. The use of accredited thirdparty CBs and food and facility
certifications helps us prevent
potentially harmful food from reaching
U.S. consumers and thereby improve
the safety of the U.S. food supply. This
collection of information increases
efficiency by reducing the number of
redundant audits to assess compliance
with applicable food safety
requirements of the FD&C Act and FDA
regulations.
FDA estimates the burden of the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
khammond on DSKBBV9HB2PROD with NOTICES
21 CFR part 1; subpart M
§ 1.615 2 ...............................................................
§ 1.645 2 ...............................................................
§ 1.624(d) 2 ..........................................................
§ 1.657(d) 2 ..........................................................
Contract modification 2 .........................................
§ 1.651 2 ...............................................................
§ 1.653(b)(2) 2 ......................................................
§ 1.625 .................................................................
VerDate Sep<11>2014
16:34 Jun 14, 2019
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PO 00000
Number of
records per
recordkeeper
7
68
7
68
7
68
68
25
Frm 00059
Fmt 4703
1
1
1
1
9
48.5
1
426
Sfmt 4703
Total
annual
records
7
68
7
68
63
3,298
68
10,650
Average
burden per
recordkeeping
2 .....................................
2 .....................................
160 .................................
160 .................................
2 .....................................
2 .....................................
1 .....................................
0.25 (15 minutes) ...........
E:\FR\FM\17JNN1.SGM
17JNN1
Total
hours
14
136
1,120
10,880
126
6,596
68
2,663
Federal Register / Vol. 84, No. 116 / Monday, June 17, 2019 / Notices
28059
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR part 1; subpart M
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
§ 1.624(c) .............................................................
§ 1.657(d) .............................................................
§ 1.652 .................................................................
§ 1.653(b)(2) ........................................................
§ 1.656(c) .............................................................
25
208
208
208
208
1
1
48.5
48.5
0.25
25
208
10,088
10,088
52
8 .....................................
8 .....................................
0.083 (5 minutes) ...........
0.083 (5 minutes) ...........
1 .....................................
200
1,664
837
837
52
Total Annual Recordkeeping Burden ...........
........................
........................
........................
........................................
25,193
1 There
2 Initial
are no capital costs or operating and maintenance costs associated with annual recordkeeping burden.
burden for an AB seeking recognition or a CB seeking accreditation.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR part 1; subpart M
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
annual
responses
Total
hours
§ 1.630 2 ...............................................................
§ 1.670 2 ...............................................................
§ 1.634 .................................................................
§ 1.672 .................................................................
§ 1.623(a) .............................................................
§ 1.623(b) .............................................................
§ 1.653(b)(1) ........................................................
§ 1.656(a) 3 ..........................................................
§ 1.656(a) 4 ..........................................................
§ 1.656(a) 5 ..........................................................
§ 1.656(b) 6 ..........................................................
§ 1.656(b) 7 ..........................................................
§ 1.656(c) .............................................................
§ 1.656(e) 8 ..........................................................
§ 1.656(e) 9 ..........................................................
7
1
25
1
25
25
208
207
207
1
207
1
208
208
207
1
1
1
1
9
1
48.5
48.5
48.5
55.4
1
1
0.25
0.25
0.25
7
1
25
1
225
25
10,088
10,040
10,040
55
207
1
52
52
52
80 ...................................
80 ...................................
8 .....................................
10 ...................................
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
560
80
200
10
56
6
2,522
2,510
2,510
14
52
1
13
13
13
Total Annual Reporting Burden ...................
........................
........................
........................
........................................
8,560
1 There
are no capital costs or operating and maintenance costs associated with annual reporting.
burden for an AB seeking recognition or a CB seeking accreditation.
3 Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.
4 Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to FDA.
5 Annual reporting of regulatory audit reports by directly accredited CBs to FDA.
6 Annual reporting of self-assessment by accredited CBs to their recognized ABs.
7 Annual reporting of self-assessment by directly-accredited CBs to FDA.
8 Annual reporting of serious risk to public health by CBs accredited under the third-party program to eligible entities.
9 Annual reporting of serious risk to public health by accredited CBs to their recognized ABs.
khammond on DSKBBV9HB2PROD with NOTICES
2 Initial
The total annual recordkeeping
burden by 25 recognized ABs and 208
CBs accredited under the third-party
program is estimated at 25,193 hours
(see table 1). We assume that all ABs
that apply for recognition in the
program become recognized and all CBs
that apply for accreditation are
accredited. The total annual reporting
burden by 25 recognized ABs and 208
CBs accredited under the program is
estimated at 8,560 hours (see table 2).
These estimates reflect a correction to
the estimates published in the last 60day notice, which did not include
estimates for the initial burden needed
to apply for entry into the program.
We have adjusted our burden estimate
since the last OMB approval to reflect
the decrease of burden associated with
one-time recordkeeping and reporting
activities and have revised our estimate
VerDate Sep<11>2014
16:34 Jun 14, 2019
Jkt 247001
to reflect the initial burden for new ABs
seeking recognition and new CBs
seeking accreditation. The adjustment
resulted in decreases of 7,421 responses
and 41,069 total burden hours.
Dated: June 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12703 Filed 6–14–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0350]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Tobacco Retailers on Tobacco Retailer
Training Programs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
SUMMARY:
Frm 00060
Fmt 4703
Sfmt 4703
E:\FR\FM\17JNN1.SGM
17JNN1
]]>Agencies
[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Pages 28057-28059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12703]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0721]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Accreditation of
Third-Party Certification Bodies To Conduct Food Safety Audits and
Issue Certifications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July
17, 2019.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0331.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
[[Page 28058]]
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Accreditation of Third-Party Certification Bodies To Conduct Food
Safety Audits and To Issue Certifications--21 CFR Part 1; Subpart M
OMB Control Number 0910-0750--Extension
FDA provides for accreditation of third-party certification bodies
(CBs) to conduct food safety audits of eligible foreign food
facilities, and issue food and facility certifications, pursuant to the
FDA Food Safety Modernization Act. In accordance with 21 CFR part
1.600, subpart M, FDA uses certifications issued by accredited third-
party CBs in deciding whether to admit certain imported food into the
United States that FDA has determined poses a food safety risk and in
deciding whether an importer is eligible to participate in a program
for expedited review and entry of food imports. Except for limited
circumstances in which we may directly accredit CBs to participate in
the accredited third-party audits and certification program, we will
recognize accreditation bodies (ABs) to accredit third-party CBs. Use
of accredited third-party CBs and food and facility certifications
helps us prevent potentially harmful food from reaching U.S. consumers
and thereby improve the safety of the U.S. food supply. This collection
of information increases efficiency by reducing the number of redundant
audits to assess compliance with applicable food safety requirements of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA
regulations.
We estimate that there are about 200,000 foreign food and feed
exporters that offer their food and feed for import into the United
States. These foreign food and feed exporters include approximately
130,000 food and feed production facilities and approximately 71,000
farms. A proportion of these foreign food and feed exporters may offer
food subject to mandatory certification requirements under section
801(q) of the FD&C Act (21 U.S.C. 381(q)(3)). In that case, the
eligible entities must either comply with this collection of
information to obtain certification from a CB accredited under the
third-party program to continue exporting their food products into the
United States, obtain certification from a foreign government
designated by FDA, or lose their access to U.S. markets. We assume that
in any given year, 75 foreign food and feed exporters will be subject
to section 801(q) of the FD&C Act.
We estimate that 25 ABs will accredit CBs that will conduct food
safety audits of foreign eligible entities that offer food or feed for
import to the United States. We also estimate that approximately 207
CBs accredited by the 25 AB applicants will comply with the collection
of information to participate in the program. In addition, we expect
that one CB will apply and participate in the third-party program via
direct accreditation by FDA under this collection of information.
In the Federal Register of February 20, 2019 (84 FR 5084), we
published a 60-day notice requesting public comment on the proposed
collection of information. Several comments were submitted, however
only those responsive to the information collection topics solicited
are addressed here.
(Comment 1) One comment suggested that the Agency should conduct
all food safety audits instead of allowing third-party entities to
conduct them, which would allow for greater accountability.
(Response) With current resources, we do not have the ability to
conduct food safety audits for the thousands of foreign suppliers that
could potentially be interested in using this program to establish
eligibility for Voluntary Qualified Importer Program under section 806
of the FD&C Act (21 U.S.C. 384b) or meet the certification requirements
under section 801(q) of the FD&C Act. With accredited third-party CBs
and ABs, we can leverage their food safety activities to benefit our
system of public food safety assurances. The regulation for
accreditation of third-party CBs includes requirements for the
accredited CBs to demonstrate their competence and capability to
determine an eligible entity's compliance with the applicable food
safety requirements of the FD&C Act and FDA regulations. In leveraging
private food safety activities, we can prevent potentially harmful food
from reaching U.S. consumers and thereby improve the safety of the U.S.
food supply.
(Comment 2) One comment suggested that there would be less burden
for the public to deal directly with FDA instead of a third party.
(Response) The Third-Party Program reduces burden for the public.
Widespread participation and broad acceptance of audits and
certifications under the program helps increase efficiency by
eliminating redundant auditing to assess foreign suppliers' compliance
with the FD&C Act and FDA regulations.
(Comment 3) One comment offered that the Third-Party Program is a
resourceful and competitive way to perform food safety audits and issue
certifications.
(Response) We agree with this comment. The use of accredited third-
party CBs and food and facility certifications helps us prevent
potentially harmful food from reaching U.S. consumers and thereby
improve the safety of the U.S. food supply. This collection of
information increases efficiency by reducing the number of redundant
audits to assess compliance with applicable food safety requirements of
the FD&C Act and FDA regulations.
FDA estimates the burden of the collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part 1; subpart M Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 1.615 \2\.......................... 7 1 7 2........................................... 14
Sec. 1.645 \2\.......................... 68 1 68 2........................................... 136
Sec. 1.624(d) \2\....................... 7 1 7 160......................................... 1,120
Sec. 1.657(d) \2\....................... 68 1 68 160......................................... 10,880
Contract modification \2\................. 7 9 63 2........................................... 126
Sec. 1.651 \2\.......................... 68 48.5 3,298 2........................................... 6,596
Sec. 1.653(b)(2) \2\.................... 68 1 68 1........................................... 68
Sec. 1.625.............................. 25 426 10,650 0.25 (15 minutes)........................... 2,663
[[Page 28059]]
Sec. 1.624(c)........................... 25 1 25 8........................................... 200
Sec. 1.657(d)........................... 208 1 208 8........................................... 1,664
Sec. 1.652.............................. 208 48.5 10,088 0.083 (5 minutes)........................... 837
Sec. 1.653(b)(2)........................ 208 48.5 10,088 0.083 (5 minutes)........................... 837
Sec. 1.656(c)........................... 208 0.25 52 1........................................... 52
---------------
Total Annual Recordkeeping Burden..... .............. .............. .............. ............................................ 25,193
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with annual recordkeeping burden.
\2\ Initial burden for an AB seeking recognition or a CB seeking accreditation.
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part 1; subpart M Number of responses per Total annual Average burden per response (in hours) Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 1.630 \2\.......................... 7 1 7 80.......................................... 560
Sec. 1.670 \2\.......................... 1 1 1 80.......................................... 80
Sec. 1.634.............................. 25 1 25 8........................................... 200
Sec. 1.672.............................. 1 1 1 10.......................................... 10
Sec. 1.623(a)........................... 25 9 225 0.25 (15 minutes)........................... 56
Sec. 1.623(b)........................... 25 1 25 0.25 (15 minutes)........................... 6
Sec. 1.653(b)(1)........................ 208 48.5 10,088 0.25 (15 minutes)........................... 2,522
Sec. 1.656(a) \3\....................... 207 48.5 10,040 0.25 (15 minutes)........................... 2,510
Sec. 1.656(a) \4\....................... 207 48.5 10,040 0.25 (15 minutes)........................... 2,510
Sec. 1.656(a) \5\....................... 1 55.4 55 0.25 (15 minutes)........................... 14
Sec. 1.656(b) \6\....................... 207 1 207 0.25 (15 minutes)........................... 52
Sec. 1.656(b) \7\....................... 1 1 1 0.25 (15 minutes)........................... 1
Sec. 1.656(c)........................... 208 0.25 52 0.25 (15 minutes)........................... 13
Sec. 1.656(e) \8\....................... 208 0.25 52 0.25 (15 minutes)........................... 13
Sec. 1.656(e) \9\....................... 207 0.25 52 0.25 (15 minutes)........................... 13
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Total Annual Reporting Burden......... .............. .............. .............. ............................................ 8,560
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\1\ There are no capital costs or operating and maintenance costs associated with annual reporting.
\2\ Initial burden for an AB seeking recognition or a CB seeking accreditation.
\3\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.
\4\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to FDA.
\5\ Annual reporting of regulatory audit reports by directly accredited CBs to FDA.
\6\ Annual reporting of self-assessment by accredited CBs to their recognized ABs.
\7\ Annual reporting of self-assessment by directly-accredited CBs to FDA.
\8\ Annual reporting of serious risk to public health by CBs accredited under the third-party program to eligible entities.
\9\ Annual reporting of serious risk to public health by accredited CBs to their recognized ABs.
The total annual recordkeeping burden by 25 recognized ABs and 208
CBs accredited under the third-party program is estimated at 25,193
hours (see table 1). We assume that all ABs that apply for recognition
in the program become recognized and all CBs that apply for
accreditation are accredited. The total annual reporting burden by 25
recognized ABs and 208 CBs accredited under the program is estimated at
8,560 hours (see table 2). These estimates reflect a correction to the
estimates published in the last 60-day notice, which did not include
estimates for the initial burden needed to apply for entry into the
program.
We have adjusted our burden estimate since the last OMB approval to
reflect the decrease of burden associated with one-time recordkeeping
and reporting activities and have revised our estimate to reflect the
initial burden for new ABs seeking recognition and new CBs seeking
accreditation. The adjustment resulted in decreases of 7,421 responses
and 41,069 total burden hours.
Dated: June 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12703 Filed 6-14-19; 8:45 am]
BILLING CODE 4164-01-P
