Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle, 56615-56617 [2017-25767]
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Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
Reduced may be stored at ¥18 °C or
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• Preparation of Plasma Frozen
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Subsequent to this approval, the
USPTO received a patent term
restoration application for SOLX
SYSTEM (U.S. Patent No. 6,150,085)
from Haemonetics Corporation, and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
November 5, 2015, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of SOLX
SYSTEM represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
pmangrum on DSK3GDR082PROD with NOTICES1
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
SOLX SYSTEM is 1,250 days. Of this
time, 708 days occurred during the
testing phase of the regulatory review
period, while 542 days occurred during
the approval phase. These periods of
time were derived from the following
dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective:
November 24, 2009. The applicant
claims November 25, 2009, as the date
the investigational new drug application
(IND) became effective. However, FDA
records indicate that the IND effective
date was November 24, 2009, which was
30 days after FDA receipt of the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: November 1,
2011. FDA has verified the applicant’s
claim that the new drug application
(NDA) for SOLX SYSTEM (NDA
BN110059) was initially submitted on
November 1, 2011.
3. The date the application was
approved: April 25, 2013. FDA has
verified the applicant’s claim that NDA
BN110059 was approved on April 25,
2013.
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15:19 Nov 28, 2017
Jkt 241001
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 894 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25773 Filed 11–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0505]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recordkeeping
and Reporting Requirements for
Human Food and Cosmetics
Manufactured From, Processed With,
or Otherwise Containing Material From
Cattle
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
ACTION:
56615
Notice.
The Food and Drug
Administration (FDA) 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 December
29, 2017.
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 0910–0623. Also,
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Recordkeeping and Reporting
Requirements for Human Food and
Cosmetics Manufactured From,
Processed With, or Otherwise
Containing Material From Cattle—21
CFR 189.5 and 700.27
OMB Control Number 0910–0623—
Extension
FDA’s regulations in §§ 189.5 and
700.27 (21 CFR 189.5 and 700.27) set
forth bovine spongiform
encephalopathy (BSE)-related
restrictions applicable to FDA-regulated
human food and cosmetics. The
regulations designate certain materials
from cattle as ‘‘prohibited cattle
materials,’’ including specified risk
materials (SRMs), the small intestine of
cattle not otherwise excluded from
being a prohibited cattle material,
material from nonambulatory disabled
cattle, and mechanically separated (MS)
beef. Sections 189.5(c) and 700.27(c) set
forth the requirements for recordkeeping
and records access for FDA-regulated
human food, including dietary
supplements, and cosmetics
manufactured from, processed with, or
otherwise containing material derived
E:\FR\FM\29NON1.SGM
29NON1
56616
Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
pmangrum on DSK3GDR082PROD with NOTICES1
from cattle. FDA issued these
recordkeeping regulations under the
adulteration provisions in sections
402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c),
and 701(a) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5),
361(c), and 371(a)). Under section 701(a)
of the FD&C Act, FDA is authorized to
issue regulations for the FD&C Act’s
efficient enforcement. With regard to
records concerning imported human
food and cosmetics, FDA relied on its
authority under sections 701(b) and
801(a) of the FD&C Act (21 U.S.C. 371(b)
and 381(a)). Section 801(a) of the FD&C
Act provides requirements with regard
to imported human food and cosmetics
and provides for refusal of admission of
human food and cosmetics that appear
to be adulterated into the United States.
Section 701(b) of the FD&C Act
authorizes the Secretaries of Treasury
and Health and Human Services to
jointly prescribe regulations for the
efficient enforcement of section 801 of
the FD&C Act.
These requirements are necessary
because once materials are separated
from an animal it may not be possible,
without records, to know the following:
(1) Whether cattle material may contain
SRMs (brain, skull, eyes, trigeminal
ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the
transverse processes of the thoracic and
lumbar vertebrae and the wings of the
sacrum), and dorsal root ganglia from
animals 30 months and older and
tonsils and distal ileum of the small
intestine from all animals of all ages);
(2) whether the source animal for cattle
material was inspected and passed; (3)
whether the source animal for cattle
material was nonambulatory disabled or
MS beef; and (4) whether tallow in
human food or cosmetics contain less
than 0.15 percent insoluble impurities.
FDA’s regulations in §§ 189.5(c) and
700.27(c) require manufacturers and
processors of human food and cosmetics
manufactured from, processed with, or
otherwise containing material from
cattle establish and maintain records
sufficient to demonstrate that the
human food or cosmetics are not
manufactured from, processed with, or
otherwise contains prohibited cattle
materials. These records must be
retained for 2 years at the manufacturing
or processing establishment or at a
reasonably accessible location.
Maintenance of electronic records is
acceptable, and electronic records are
considered to be reasonably accessible if
they are accessible from an onsite
location. Records required by these
sections and existing records relevant to
compliance with these sections must be
available to FDA for inspection and
copying. Existing records may be used
if they contain all of the required
information and are retained for the
required time period.
Because FDA does not easily have
access to records maintained at foreign
establishments, FDA regulations in
§§ 189.5(c)(6) and 700.27(c)(6),
respectively, require that when filing for
entry with U.S. Customs and Border
Protection (CBP), the importer of record
of human food or cosmetics
manufactured from, processed with, or
otherwise containing cattle material
must affirm that the human food or
cosmetics were manufactured from,
processed with, or otherwise
containing-cattle material and must
affirm that the human food or cosmetics
were manufactured in accordance with
the applicable requirements of §§ 189.5
or 700.27. In addition, if human food or
cosmetics were manufactured from,
processed with, or otherwise
containing-cattle material, the importer
of record must provide within 5
business days records sufficient to
demonstrate that the human food or
cosmetics were not manufactured from,
processed with, or otherwise contains
prohibited cattle material, if requested.
Under FDA’s regulations, FDA may
designate a country from which cattle
materials inspected and passed for
human consumption are not considered
prohibited cattle materials, and their use
does not render human food or
cosmetics adulterated. Sections 189.5(e)
and 700.27(e) provide that a country
seeking to be designated must send a
written request to the Director of the
Center for Food Safety and Applied
Nutrition (CFSAN Director). The
information the country is required to
submit includes information about a
country’s BSE case history, risk factors,
measures to prevent the introduction
and transmission of BSE, and any other
information relevant to determining
whether SRMs, the small intestine of
cattle not otherwise excluded from
being a prohibited cattle material,
material from nonambulatory disabled
cattle, or MS beef from the country
seeking designation should be
considered prohibited cattle materials.
FDA uses the information to determine
whether to grant a request for
designation and to impose conditions if
a request is granted.
Sections 189.5 and 700.27 further
state that countries designated under
§§ 189.5(e) and 700.27(e) will be subject
to future review by FDA to determine
whether their designations remain
appropriate. As part of this process,
FDA may ask designated countries to
confirm their BSE situation and that the
information submitted by them, in
support of their original application, has
remained unchanged. FDA may revoke
a country’s designation if FDA
determines that it is no longer
appropriate. Therefore, designated
countries may respond to periodic FDA
requests by submitting information to
confirm their designations remain
appropriate. FDA uses the information
to ensure their designations remain
appropriate.
Description of Respondents:
Respondents to this information
collection include manufacturers,
processors, and importers of FDA
regulated human food, including dietary
supplements, and cosmetics
manufactured from, processed with, or
otherwise containing material derived
from cattle, as well as, with regard to
§§ 189.5(e) and 700.27(e), foreign
governments seeking designation under
those regulations.
In the Federal Register of June 15,
2017 (82 FR 27501), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received three
comments. One comment was unrelated
to the information collection; one
comment noted that the length of time
to keep records was insufficient but
offered no suggested timeframe; and one
comment supported the information
collection. After evaluating these
comments FDA will not revise the
information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
189.5(c)(6) and 700.27(c)(6) ....................................
189.5(e) and 700.27(e); request for designation .....
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15:19 Nov 28, 2017
Jkt 241001
PO 00000
Number of
responses per
respondent
54,825
1
Frm 00037
Fmt 4703
1
1
Sfmt 4703
Total annual
responses
54,825
1
E:\FR\FM\29NON1.SGM
Average burden
per response
0.033 (2 minutes) ......
80 ..............................
29NON1
Total hours
1,809
80
56617
Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section
Total annual
responses
Average burden
per response
Total hours
189.5(e) and 700.27(e); response to request for review by FDA.
1
1
1
26 ..............................
26
Total ..................................................................
........................
........................
........................
....................................
1,915
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeper
Total hours
Domestic facilities ....................................................
Foreign facilities .......................................................
697
916
52
52
36,244
47,632
0.25 (15 minutes) ......
0.25 (15 minutes) ......
9,061
11,908
Total ..................................................................
........................
........................
........................
....................................
20,969
pmangrum on DSK3GDR082PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Except where otherwise noted, this
estimate is based on FDA’s estimate of
the number of facilities affected by the
final rule entitled ‘‘Recordkeeping
Requirements for Human Food and
Cosmetics Manufactured From,
Processed With, or Otherwise
Containing Material From Cattle’’
published in the Federal Register of
October 11, 2006 (71 FR 59653).
Reporting: FDA’s regulations in
§§ 189.5(c)(6) and 700.27(c)(6) impose a
reporting burden on importers of human
food and cosmetics manufactured from,
processed with, or otherwise containing
cattle material. Importers of these
products must affirm that the human
food or cosmetics are not manufactured
from, processed with, or otherwise
contain prohibited cattle materials and
must affirm that the human food or
cosmetics were manufactured in
accordance with the applicable
requirements of §§ 189.5 or 700.27. The
affirmation is made by the importer of
record at CBP entry. Affirmation by
importers is expected to take
approximately 2 minutes per entry line.
Table 1 shows 54,825 lines of human
food and cosmetics likely to contain
cattle materials are imported annually.
The reporting burden of affirming
whether import entry lines contain
cattle-derived materials is estimated to
take 1,809 hours annually (54,825 lines
× 2 minutes per line).
FDA’s estimate of the reporting
burden for designation under §§ 189.5
and 700.27 is based on its experience
and the average number of requests for
designation received in the past 3 years.
In the last 3 years, FDA has not received
any requests for designation. Thus, FDA
estimates that one or fewer will be
received annually in the future. Based
VerDate Sep<11>2014
15:19 Nov 28, 2017
Jkt 241001
on this experience, FDA estimates the
annual number of new requests for
designation will be one. FDA estimates
that preparing the information required
by §§ 189.5 and 700.27 and submitting
it to FDA in the form of a written
request to the CFSAN Director will
require a burden of approximately 80
hours per request. Thus, the burden for
new requests for designation is
estimated to be 80 hours annually, as
shown in table 1, row 2.
Under §§ 189.5(e) and 700.27(e),
designated countries are subject to
future review by FDA and may respond
to periodic FDA requests by submitting
information to confirm their
designations remain appropriate. In the
last 3 years, FDA has not requested any
reviews. Thus, FDA estimates that one
or fewer will occur annually in the
future. FDA estimates that the
designated country undergoing a review
in the future will need one-third of the
time it took preparing its request for
designation to respond to FDA’s request
for review, or 26 hours (80 hours × 0.33
= 26.4 hours, rounded to 26). The
annual burden for reviews is estimated
to be 26 hours, as shown in table 1, row
3. The total reporting burden for this
information collection is estimated to be
1,915 hours annually.
Recordkeeping: FDA estimates that
there are 697 domestic facility
relationships and 916 foreign facility
relationships consisting of the following
facilities: An input supplier of cattlederived materials that requires records
(the upstream facility) and a purchaser
of cattle-derived materials requiring
documentation (this may be a human
food or cosmetics manufacturer or
processor). The recordkeeping burden of
FDA’s regulations in §§ 189.5(c) and
PO 00000
Frm 00038
Fmt 4703
Sfmt 9990
700.27(c) is the burden of sending,
verifying, and storing documents
regarding shipments of cattle material
that is to be used in human food and
cosmetics.
In this estimate of the recordkeeping
burden, FDA treats these recordkeeping
activities as shared activities between
the upstream and downstream facilities.
It is in the best interests of both facilities
in the relationship to share the burden
necessary to comply with the
regulations; therefore, FDA estimates
the time burden of developing these
records as a joint task between the two
facilities. Thus, FDA estimates that this
recordkeeping burden will be about 15
minutes per week, or 13 hours per year,
and FDA assumes that the
recordkeeping burden will be shared
between two entities (i.e., the ingredient
supplier and the manufacturer of
finished products). Therefore, the total
recordkeeping burden for domestic
facilities is estimated to be 9,061 hours
(13 hours × 697), and the total
recordkeeping burden for foreign
facilities is estimated to be 11,908 hours
(13 hours × 916), as shown in table 2.
Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25767 Filed 11–28–17; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\29NON1.SGM
29NON1
Agencies
[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56615-56617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25767]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0505]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recordkeeping and
Reporting Requirements for Human Food and Cosmetics Manufactured From,
Processed With, or Otherwise Containing Material From Cattle
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the 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
December 29, 2017.
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 0910-0623.
Also, include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
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.
Recordkeeping and Reporting Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle--21 CFR 189.5 and 700.27
OMB Control Number 0910-0623--Extension
FDA's regulations in Sec. Sec. 189.5 and 700.27 (21 CFR 189.5 and
700.27) set forth bovine spongiform encephalopathy (BSE)-related
restrictions applicable to FDA-regulated human food and cosmetics. The
regulations designate certain materials from cattle as ``prohibited
cattle materials,'' including specified risk materials (SRMs), the
small intestine of cattle not otherwise excluded from being a
prohibited cattle material, material from nonambulatory disabled
cattle, and mechanically separated (MS) beef. Sections 189.5(c) and
700.27(c) set forth the requirements for recordkeeping and records
access for FDA-regulated human food, including dietary supplements, and
cosmetics manufactured from, processed with, or otherwise containing
material derived
[[Page 56616]]
from cattle. FDA issued these recordkeeping regulations under the
adulteration provisions in sections 402(a)(2)(C), (a)(3), (a)(4),
(a)(5), 601(c), and 701(a) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c),
and 371(a)). Under section 701(a) of the FD&C Act, FDA is authorized to
issue regulations for the FD&C Act's efficient enforcement. With regard
to records concerning imported human food and cosmetics, FDA relied on
its authority under sections 701(b) and 801(a) of the FD&C Act (21
U.S.C. 371(b) and 381(a)). Section 801(a) of the FD&C Act provides
requirements with regard to imported human food and cosmetics and
provides for refusal of admission of human food and cosmetics that
appear to be adulterated into the United States. Section 701(b) of the
FD&C Act authorizes the Secretaries of Treasury and Health and Human
Services to jointly prescribe regulations for the efficient enforcement
of section 801 of the FD&C Act.
These requirements are necessary because once materials are
separated from an animal it may not be possible, without records, to
know the following: (1) Whether cattle material may contain SRMs
(brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the transverse processes of the
thoracic and lumbar vertebrae and the wings of the sacrum), and dorsal
root ganglia from animals 30 months and older and tonsils and distal
ileum of the small intestine from all animals of all ages); (2) whether
the source animal for cattle material was inspected and passed; (3)
whether the source animal for cattle material was nonambulatory
disabled or MS beef; and (4) whether tallow in human food or cosmetics
contain less than 0.15 percent insoluble impurities.
FDA's regulations in Sec. Sec. 189.5(c) and 700.27(c) require
manufacturers and processors of human food and cosmetics manufactured
from, processed with, or otherwise containing material from cattle
establish and maintain records sufficient to demonstrate that the human
food or cosmetics are not manufactured from, processed with, or
otherwise contains prohibited cattle materials. These records must be
retained for 2 years at the manufacturing or processing establishment
or at a reasonably accessible location. Maintenance of electronic
records is acceptable, and electronic records are considered to be
reasonably accessible if they are accessible from an onsite location.
Records required by these sections and existing records relevant to
compliance with these sections must be available to FDA for inspection
and copying. Existing records may be used if they contain all of the
required information and are retained for the required time period.
Because FDA does not easily have access to records maintained at
foreign establishments, FDA regulations in Sec. Sec. 189.5(c)(6) and
700.27(c)(6), respectively, require that when filing for entry with
U.S. Customs and Border Protection (CBP), the importer of record of
human food or cosmetics manufactured from, processed with, or otherwise
containing cattle material must affirm that the human food or cosmetics
were manufactured from, processed with, or otherwise containing-cattle
material and must affirm that the human food or cosmetics were
manufactured in accordance with the applicable requirements of
Sec. Sec. 189.5 or 700.27. In addition, if human food or cosmetics
were manufactured from, processed with, or otherwise containing-cattle
material, the importer of record must provide within 5 business days
records sufficient to demonstrate that the human food or cosmetics were
not manufactured from, processed with, or otherwise contains prohibited
cattle material, if requested.
Under FDA's regulations, FDA may designate a country from which
cattle materials inspected and passed for human consumption are not
considered prohibited cattle materials, and their use does not render
human food or cosmetics adulterated. Sections 189.5(e) and 700.27(e)
provide that a country seeking to be designated must send a written
request to the Director of the Center for Food Safety and Applied
Nutrition (CFSAN Director). The information the country is required to
submit includes information about a country's BSE case history, risk
factors, measures to prevent the introduction and transmission of BSE,
and any other information relevant to determining whether SRMs, the
small intestine of cattle not otherwise excluded from being a
prohibited cattle material, material from nonambulatory disabled
cattle, or MS beef from the country seeking designation should be
considered prohibited cattle materials. FDA uses the information to
determine whether to grant a request for designation and to impose
conditions if a request is granted.
Sections 189.5 and 700.27 further state that countries designated
under Sec. Sec. 189.5(e) and 700.27(e) will be subject to future
review by FDA to determine whether their designations remain
appropriate. As part of this process, FDA may ask designated countries
to confirm their BSE situation and that the information submitted by
them, in support of their original application, has remained unchanged.
FDA may revoke a country's designation if FDA determines that it is no
longer appropriate. Therefore, designated countries may respond to
periodic FDA requests by submitting information to confirm their
designations remain appropriate. FDA uses the information to ensure
their designations remain appropriate.
Description of Respondents: Respondents to this information
collection include manufacturers, processors, and importers of FDA
regulated human food, including dietary supplements, and cosmetics
manufactured from, processed with, or otherwise containing material
derived from cattle, as well as, with regard to Sec. Sec. 189.5(e) and
700.27(e), foreign governments seeking designation under those
regulations.
In the Federal Register of June 15, 2017 (82 FR 27501), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received three comments. One comment was
unrelated to the information collection; one comment noted that the
length of time to keep records was insufficient but offered no
suggested timeframe; and one comment supported the information
collection. After evaluating these comments FDA will not revise the
information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
189.5(c)(6) and 700.27(c)(6)................ 54,825 1 54,825 0.033 (2 minutes)......................... 1,809
189.5(e) and 700.27(e); request for 1 1 1 80........................................ 80
designation.
[[Page 56617]]
189.5(e) and 700.27(e); response to request 1 1 1 26........................................ 26
for review by FDA.
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Total................................... .............. .............. .............. .......................................... 1,915
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records
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Domestic facilities......................... 697 52 36,244 0.25 (15 minutes)......................... 9,061
Foreign facilities.......................... 916 52 47,632 0.25 (15 minutes)......................... 11,908
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Total................................... .............. .............. .............. .......................................... 20,969
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Except where otherwise noted, this estimate is based on FDA's
estimate of the number of facilities affected by the final rule
entitled ``Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle'' published in the Federal Register of October 11, 2006 (71
FR 59653).
Reporting: FDA's regulations in Sec. Sec. 189.5(c)(6) and
700.27(c)(6) impose a reporting burden on importers of human food and
cosmetics manufactured from, processed with, or otherwise containing
cattle material. Importers of these products must affirm that the human
food or cosmetics are not manufactured from, processed with, or
otherwise contain prohibited cattle materials and must affirm that the
human food or cosmetics were manufactured in accordance with the
applicable requirements of Sec. Sec. 189.5 or 700.27. The affirmation
is made by the importer of record at CBP entry. Affirmation by
importers is expected to take approximately 2 minutes per entry line.
Table 1 shows 54,825 lines of human food and cosmetics likely to
contain cattle materials are imported annually. The reporting burden of
affirming whether import entry lines contain cattle-derived materials
is estimated to take 1,809 hours annually (54,825 lines x 2 minutes per
line).
FDA's estimate of the reporting burden for designation under
Sec. Sec. 189.5 and 700.27 is based on its experience and the average
number of requests for designation received in the past 3 years. In the
last 3 years, FDA has not received any requests for designation. Thus,
FDA estimates that one or fewer will be received annually in the
future. Based on this experience, FDA estimates the annual number of
new requests for designation will be one. FDA estimates that preparing
the information required by Sec. Sec. 189.5 and 700.27 and submitting
it to FDA in the form of a written request to the CFSAN Director will
require a burden of approximately 80 hours per request. Thus, the
burden for new requests for designation is estimated to be 80 hours
annually, as shown in table 1, row 2.
Under Sec. Sec. 189.5(e) and 700.27(e), designated countries are
subject to future review by FDA and may respond to periodic FDA
requests by submitting information to confirm their designations remain
appropriate. In the last 3 years, FDA has not requested any reviews.
Thus, FDA estimates that one or fewer will occur annually in the
future. FDA estimates that the designated country undergoing a review
in the future will need one-third of the time it took preparing its
request for designation to respond to FDA's request for review, or 26
hours (80 hours x 0.33 = 26.4 hours, rounded to 26). The annual burden
for reviews is estimated to be 26 hours, as shown in table 1, row 3.
The total reporting burden for this information collection is estimated
to be 1,915 hours annually.
Recordkeeping: FDA estimates that there are 697 domestic facility
relationships and 916 foreign facility relationships consisting of the
following facilities: An input supplier of cattle-derived materials
that requires records (the upstream facility) and a purchaser of
cattle-derived materials requiring documentation (this may be a human
food or cosmetics manufacturer or processor). The recordkeeping burden
of FDA's regulations in Sec. Sec. 189.5(c) and 700.27(c) is the burden
of sending, verifying, and storing documents regarding shipments of
cattle material that is to be used in human food and cosmetics.
In this estimate of the recordkeeping burden, FDA treats these
recordkeeping activities as shared activities between the upstream and
downstream facilities. It is in the best interests of both facilities
in the relationship to share the burden necessary to comply with the
regulations; therefore, FDA estimates the time burden of developing
these records as a joint task between the two facilities. Thus, FDA
estimates that this recordkeeping burden will be about 15 minutes per
week, or 13 hours per year, and FDA assumes that the recordkeeping
burden will be shared between two entities (i.e., the ingredient
supplier and the manufacturer of finished products). Therefore, the
total recordkeeping burden for domestic facilities is estimated to be
9,061 hours (13 hours x 697), and the total recordkeeping burden for
foreign facilities is estimated to be 11,908 hours (13 hours x 916), as
shown in table 2.
Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25767 Filed 11-28-17; 8:45 am]
BILLING CODE 4164-01-P