80 FR 34681 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 116 (June 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 116 (June 17, 2015)
| Page Range | 34681-34682 | |
| FR Document | 2015-14886 |
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)] [Notices] [Pages 34681-34682] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14886] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0473] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food 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 July 17, 2015. 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 0910-0186. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver Spring, MD 20993-0002 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. Irradiation in the Production, Processing, and Handling of Food--21 CFR Part 179 (OMB Control Number 0910-0186)--Extension Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(s) and 348), food irradiation is subject to regulation under the food additive premarket approval provisions of the FD&C Act. The regulations providing for uses of irradiation in the production, processing, and handling of food are found in part 179 (21 CFR part 179). To ensure safe use of a radiation source, Sec. 179.21(b)(1) requires that the label of sources bear appropriate and accurate information identifying the source of radiation and the maximum (or minimum and maximum) energy of the emitted radiation. Section 179.21(b)(2) requires that the label or accompanying labeling bear adequate directions for installation and use and a statement supplied by us that indicates maximum dose of radiation allowed. Section 179.26(c) requires that the label or accompanying labeling bear a logo and a radiation disclosure statement. Section 179.25(e) requires that food processors who treat food with radiation make and retain, for 1 year past the expected shelf life of the products up to a maximum of 3 years, specified records relating to the irradiation process (e.g., the food treated, lot identification, scheduled process, etc.). The records required by Sec. 179.25(e) are used by our inspectors to assess compliance with the regulation that establishes limits within which radiation may be safely used to treat food. We cannot ensure safe use without a method to assess compliance with the dose limits, and there are no practicable methods for analyzing most foods to determine whether they have been treated with ionizing radiation and are within the limitations set forth in part 179. Records inspection is the only way to determine whether firms are complying with the regulations for treatment of foods with ionizing radiation. In the Federal Register of March 31, 2015 (80 FR 17055), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received but did not respond to any of the four information collection topics solicited and is therefore not addressed by the Agency. Description of respondents: Respondents are businesses engaged in the irradiation of food. We estimate the burden of this collection of information as follows: [[Page 34682]] Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR section Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- 179.25(e), large processors................................... 4 300 1,200 1 1,200 179.25(e), small processors................................... 4 30 120 1 120 ----------------------------------------------------------------------------------------- Total..................................................... ................ ................ ................ ................ 1,320 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection. We base our estimate of burden for the recordkeeping provisions of Sec. 179.25(e) on our experience regulating the safe use of radiation as a direct food additive. The number of firms who process food using irradiation is extremely limited. We estimate that there are four irradiation plants whose business is devoted primarily (i.e., approximately 100 percent) to irradiation of food and other agricultural products. Four other firms also irradiate small quantities of food. We estimate that this irradiation accounts for no more than 10 percent of the business for each of these firms. Therefore, the average estimated burden is based on four facilities devoting 100 percent of their business to food irradiation (4 x 300 hours = 1200 hours for recordkeeping annually), and four facilities devoting 10 percent of their business to food irradiation (4 x 30 hours = 120 hours for recordkeeping annually). No burden has been estimated for the labeling requirements in Sec. Sec. 179.21(b)(1), 179.21(b)(2) and 179.26(c) because the information to be disclosed is information that has been supplied by FDA. Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public is not subject to review by the Office of Management and Budget under the Paperwork Reduction Act. Dated: June 10, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-14886 Filed 6-16-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34681
has been in effect since 2012 and will suggestions for changes to performance Irradiation in the Production,
expire in 2017, FDA has met or goals, and not focus on other general Processing, and Handling of Food—21
exceeded nearly all submission policy issues. CFR Part 179 (OMB Control Number
performance goals while implementing 0910–0186)—Extension
Dated: June 11, 2015.
program enhancements designed to Under sections 201(s) and 409 of the
ensure more timely access to safe and Leslie Kux,
Associate Commissioner for Policy.
Federal Food, Drug, and Cosmetic Act
effective medical devices. (the FD&C Act) (21 U.S.C. 321(s) and
• Premarket Notifications (510(k)s): [FR Doc. 2015–14885 Filed 6–16–15; 8:45 am]
348), food irradiation is subject to
Comparison of outcomes for receipt BILLING CODE 4164–01–P
regulation under the food additive
cohorts at the same levels of completion
premarket approval provisions of the
(or ‘‘closure’’) show a 16 percent
FD&C Act. The regulations providing for
decrease in total review time between DEPARTMENT OF HEALTH AND uses of irradiation in the production,
FY 2010 and FY 2013 when the cohort HUMAN SERVICES processing, and handling of food are
is 99.8 percent closed, and 10 percent
found in part 179 (21 CFR part 179). To
decrease in total review time between Food and Drug Administration
ensure safe use of a radiation source,
FY 2010 and FY 2014 when the cohort
§ 179.21(b)(1) requires that the label of
is 75.8 percent closed. [Docket No. FDA–2012–N–0473]
• Premarket Approvals (PMAs): sources bear appropriate and accurate
Comparison of outcomes for receipt information identifying the source of
Agency Information Collection radiation and the maximum (or
cohorts at the same closure levels show Activities; Submission for Office of
a 32 percent decrease in total review minimum and maximum) energy of the
Management and Budget Review; emitted radiation. Section 179.21(b)(2)
times between FY 2009 and FY 2012 Comment Request; Irradiation in the
when the cohort is 98 percent closed, requires that the label or accompanying
Production, Processing, and Handling labeling bear adequate directions for
and a 26 percent decrease in total of Food
review times between FY 2009 and FY installation and use and a statement
2014 when the cohort is 41 percent supplied by us that indicates maximum
AGENCY: Food and Drug Administration, dose of radiation allowed. Section
closed. HHS.
FDA has met or exceeded all MDUFA 179.26(c) requires that the label or
III performance goals for FDA time to ACTION: Notice. accompanying labeling bear a logo and
decisions in FY 2013 and FY 2014. a radiation disclosure statement. Section
More information about FDA’s SUMMARY: The Food and Drug 179.25(e) requires that food processors
performance is available in the yearly who treat food with radiation make and
Administration (FDA) is announcing
MDUFA performance reports, which are retain, for 1 year past the expected shelf
that a proposed collection of
available online at http://www.fda.gov/ life of the products up to a maximum of
information has been submitted to the 3 years, specified records relating to the
AboutFDA/ReportsManualsForms/ Office of Management and Budget
Reports/UserFeeReports/ irradiation process (e.g., the food
(OMB) for review and clearance under treated, lot identification, scheduled
PerformanceReports/UCM2007450.htm. the Paperwork Reduction Act of 1995.
User fees and related performance process, etc.). The records required by
goals have played an important role in DATES: Fax written comments on the § 179.25(e) are used by our inspectors to
providing resources and supporting the collection of information by July 17, assess compliance with the regulation
process for the review of device 2015. that establishes limits within which
applications. radiation may be safely used to treat
ADDRESSES: To ensure that comments on food. We cannot ensure safe use without
III. What information should you know the information collection are received, a method to assess compliance with the
about the meeting? OMB recommends that written dose limits, and there are no practicable
Through this notice, we are comments be faxed to the Office of methods for analyzing most foods to
announcing a public meeting to hear Information and Regulatory Affairs, determine whether they have been
stakeholder views on the OMB, Attn: FDA Desk Officer, FAX: treated with ionizing radiation and are
reauthorization of MDUFA for fiscal 202–395–7285, or emailed to oira_ within the limitations set forth in part
years 2018 through 2022, including submission@omb.eop.gov. All 179. Records inspection is the only way
specific suggestions for any changes to comments should be identified with the to determine whether firms are
the program that we should consider. OMB control number 0910–0186. Also complying with the regulations for
We will conduct the meeting on July 13, include the FDA docket number found treatment of foods with ionizing
2015. In general, the meeting format will in brackets in the heading of this radiation.
include presentations by FDA and a document. In the Federal Register of March 31,
series of panels representing different 2015 (80 FR 17055), FDA published a
stakeholder interest groups (such as FOR FURTHER INFORMATION CONTACT: FDA 60-day notice requesting public
patient advocates, consumer protection PRA Staff, Office of Operations, Food comment on the proposed collection of
groups, industry, health care and Drug Administration, 8455 information. One comment was received
professionals, and academic Colesville Road; COLE–14526, Silver but did not respond to any of the four
asabaliauskas on DSK5VPTVN1PROD with NOTICES
researchers). FDA will also provide an Spring, MD 20993–0002 PRAStaff@ information collection topics solicited
opportunity for individuals to make fda.hhs.gov. and is therefore not addressed by the
presentations during the meeting and Agency.
for organizations and individuals to SUPPLEMENTARY INFORMATION: In Description of respondents:
submit written comments to the docket compliance with 44 U.S.C. 3507, FDA Respondents are businesses engaged in
after the meeting. The presentations has submitted the following proposed the irradiation of food.
should focus on program improvements collection of information to OMB for We estimate the burden of this
and funding issues, including specific review and clearance. collection of information as follows:
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![34682 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
179.25(e), large processors ............................. 4 300 1,200 1 1,200
179.25(e), small processors ............................ 4 30 120 1 120
Total .......................................................... ............................ ............................ ............................ ............................ 1,320
1 There are no capital costs or operating and maintenance costs associated with this collection.
We base our estimate of burden for DEPARTMENT OF HEALTH AND Guidance for Industry and FDA Staff—
the recordkeeping provisions of HUMAN SERVICES Class II Special Controls Guidance
§ 179.25(e) on our experience regulating Document: Automated Blood Cell
the safe use of radiation as a direct food Food and Drug Administration Separator Device Operating by
additive. The number of firms who [Docket No. FDA–2012–N–0115] Centrifugal or Filtration Separation
process food using irradiation is Principle (OMB Control Number 0910–
extremely limited. We estimate that Agency Information Collection 0594)—Extension
there are four irradiation plants whose Activities; Proposed Collection; Under the Safe Medical Devices Act
business is devoted primarily (i.e., Submission for Office of Management of 1990 (Pub. L. 101–629), FDA may
approximately 100 percent) to and Budget Review; Guidance for establish special controls, including
irradiation of food and other agricultural Industry and Food and Drug performance standards, postmarket
products. Four other firms also irradiate Administration Staff—Class II Special surveillance, patient registries,
small quantities of food. We estimate Controls Guidance Document: guidelines, and other appropriate
that this irradiation accounts for no Automated Blood Cell Separator actions it believes necessary to provide
more than 10 percent of the business for Device Operating by Centrifugal or reasonable assurance of the safety and
Filtration Principle effectiveness of the device. The special
each of these firms. Therefore, the
control guidance serves to support the
average estimated burden is based on AGENCY: Food and Drug Administration,
reclassification from class III to class II
four facilities devoting 100 percent of HHS. of the automated blood cell separator
their business to food irradiation (4 × ACTION: Notice. device operating on a centrifugal
300 hours = 1200 hours for separation principle intended for the
recordkeeping annually), and four SUMMARY: The Food and Drug
routine collection of blood and blood
facilities devoting 10 percent of their Administration (FDA) is announcing
components as well as the special
business to food irradiation (4 × 30 that a proposed collection of
control for the automated blood cell
hours = 120 hours for recordkeeping information has been submitted to the
separator device operating on a filtration
annually). Office of Management and Budget
separation principle intended for the
(OMB) for review and clearance under
No burden has been estimated for the routine collection of blood and blood
the Paperwork Reduction Act of 1995.
labeling requirements in §§ 179.21(b)(1), components reclassified as class II
DATES: Fax written comments on the (§ 864.9245 (21 CFR 864.9245)).
179.21(b)(2) and 179.26(c) because the
collection of information by July 17, For currently marketed products not
information to be disclosed is 2015.
information that has been supplied by approved under the premarket approval
FDA. Under 5 CFR 1320.3(c)(2), the ADDRESSES: To ensure that comments on process, the manufacturer should file
public disclosure of information the information collection are received, with FDA, for 3 consecutive years, an
OMB recommends that written annual report on the anniversary date of
originally supplied by the Federal
comments be faxed to the Office of the device reclassification from class III
Government to the recipient for the
Information and Regulatory Affairs, to class II or on the anniversary date of
purpose of disclosure to the public is
OMB, Attn: FDA Desk Officer, FAX: the 510(k) of the Federal Food, Drug,
not subject to review by the Office of and Cosmetic Act (the FD&C Act) (21
202–395–7285, or emailed to oira_
Management and Budget under the U.S.C. 360) clearance. Any subsequent
submission@omb.eop.gov. All
Paperwork Reduction Act. change to the device requiring the
comments should be identified with the
Dated: June 10, 2015. OMB control number 0910–0594. Also submission of a premarket notification
Leslie Kux, include the FDA docket number found in accordance with section 510(k) of the
Associate Commissioner for Policy. in brackets in the heading of this FD&C Act should be included in the
document. annual report. Also, a manufacturer of a
[FR Doc. 2015–14886 Filed 6–16–15; 8:45 am]
device determined to be substantially
BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: FDA
equivalent to the centrifugal or
PRA Staff, Office of Operations, Food
filtration-based automated cell separator
and Drug Administration, 8455
device intended for the routine
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Colesville Rd., COLE–14526, Silver
collection of blood and blood
Spring, MD 20993–0002, PRAStaff@
components should comply with the
fda.hhs.gov.
same general and special controls.
SUPPLEMENTARY INFORMATION: In The annual report should include, at
compliance with 44 U.S.C. 3507, FDA a minimum, a summary of anticipated
has submitted the following proposed and unanticipated adverse events that
collection of information to OMB for have occurred and that are not required
review and clearance. to be reported by manufacturers under
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Document Created: 2015-12-15 14:23:06
Document Modified: 2015-12-15 14:23:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by July 17, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver Spring, MD 20993-0002 [email protected] | |
| FR Citation | 80 FR 34681 |
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