80 FR 17055 - Agency Information Collection Activities; Proposed Collection; 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 61 (March 31, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 61 (March 31, 2015)
| Page Range | 17055-17056 | |
| FR Document | 2015-07263 |
[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)] [Notices] [Pages 17055-17056] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07263] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0473] Agency Information Collection Activities; Proposed Collection; 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 an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies must publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and allow 60 days for public comment. This notice invites comments on the information collection provisions of our requirements for food irradiation processors. DATES: Submit either electronic or written comments on the collection of information by June 1, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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 Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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, we are publishing this notice of the proposed collection of information set forth in this document. With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical utility; (2) the accuracy of our 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. 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. Description of respondents: Respondents are businesses engaged in the irradiation of food. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR section Number of records per Total annual per Total hours record-keepers 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 ------------------------------------------------------------------------------- [[Page 17056]] 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: March 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-07263 Filed 3-30-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17055
Contact: LCDR Holly Berilla, comments should be identified with the Irradiation in the Production,
Committee Management Officer and docket number found in brackets in the Processing, and Handling of Food—21
Acting Designated Federal Official, heading of this document. CFR Part 179 (OMB Control Number
CSAT National Advisory Council, 1 0910–0186)—Extension
Choke Cherry Road, Rockville, FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food Under sections 201(s) and 409 of the
Maryland 20857 (mail). Telephone: Federal Food, Drug, and Cosmetic Act
(240) 276–1252. Fax: (240) 276–2252. and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver (the FD&C Act) (21 U.S.C. 321(s) and
Email: holly.berilla@samhsa.hhs.gov. 348), food irradiation is subject to
Spring, MD 20993–0002,
Summer King, PRAStaff@fda.hhs.gov. regulation under the food additive
Statistician, SAMHSA. premarket approval provisions of the
[FR Doc. 2015–07284 Filed 3–30–15; 8:45 am] SUPPLEMENTARY INFORMATION: Under the FD&C Act. The regulations providing for
BILLING CODE 4162–20–P PRA (44 U.S.C. 3501–3520), Federal uses of irradiation in the production,
Agencies must obtain approval from the processing, and handling of food are
Office of Management and Budget found in part 179 (21 CFR part 179). To
DEPARTMENT OF HEALTH AND (OMB) for each collection of ensure safe use of a radiation source,
HUMAN SERVICES information they conduct or sponsor. § 179.21(b)(1) requires that the label of
‘‘Collection of information’’ is defined sources bear appropriate and accurate
Food and Drug Administration in 44 U.S.C. 3502(3) and 5 CFR information identifying the source of
[Docket No. FDA–2012–N–0473] 1320.3(c) and includes Agency requests radiation and the maximum (or
or requirements that members of the minimum and maximum) energy of the
Agency Information Collection emitted radiation. Section 179.21(b)(2)
public submit reports, keep records, or
Activities; Proposed Collection; requires that the label or accompanying
provide information to a third party.
Comment Request; Irradiation in the labeling bear adequate directions for
Section 3506(c)(2)(A) of the PRA (44 installation and use and a statement
Production, Processing, and Handling U.S.C. 3506(c)(2)(A)) requires Federal
of Food supplied by us that indicates maximum
Agencies to provide a 60-day notice in dose of radiation allowed. Section
AGENCY: Food and Drug Administration, the Federal Register concerning each 179.26(c) requires that the label or
HHS. proposed collection of information, accompanying labeling bear a logo and
ACTION: Notice. including each proposed extension of an a radiation disclosure statement. Section
existing collection of information, 179.25(e) requires that food processors
SUMMARY: The Food and Drug before submitting the collection to OMB who treat food with radiation make and
Administration (FDA) is announcing an for approval. To comply with this retain, for 1 year past the expected shelf
opportunity for public comment on our requirement, we are publishing this life of the products up to a maximum of
proposed collection of certain notice of the proposed collection of 3 years, specified records relating to the
information. Under the Paperwork information set forth in this document. irradiation process (e.g., the food
Reduction Act of 1995 (the PRA), treated, lot identification, scheduled
Federal Agencies must publish notice in With respect to the following
collection of information, we invite process, etc.). The records required by
the Federal Register concerning each § 179.25(e) are used by our inspectors to
proposed collection of information, comments on these topics: (1) Whether
the proposed collection of information assess compliance with the regulation
including each proposed extension of an that establishes limits within which
existing collection of information, and is necessary for the proper performance
radiation may be safely used to treat
allow 60 days for public comment. This of our functions, including whether the
food. We cannot ensure safe use without
notice invites comments on the information will have practical utility; a method to assess compliance with the
information collection provisions of our (2) the accuracy of our estimate of the dose limits, and there are no practicable
requirements for food irradiation burden of the proposed collection of methods for analyzing most foods to
processors. information, including the validity of determine whether they have been
DATES: Submit either electronic or the methodology and assumptions used; treated with ionizing radiation and are
written comments on the collection of (3) ways to enhance the quality, utility, within the limitations set forth in part
information by June 1, 2015. and clarity of the information to be 179. Records inspection is the only way
ADDRESSES: Submit electronic collected; and (4) ways to minimize the to determine whether firms are
comments on the collection of burden of the collection of information complying with the regulations for
information to http:// on respondents, including through the treatment of foods with ionizing
www.regulations.gov. Submit written use of automated collection techniques, radiation.
comments on the collection of when appropriate, and other forms of Description of respondents:
information to the Division of Dockets information technology. Respondents are businesses engaged in
Management (HFA–305), Food and Drug the irradiation of food.
Administration, 5630 Fishers Lane, Rm. We estimate the burden of this
1061, Rockville, MD 20852. All collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
record-keepers 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
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![17056 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
record-keepers records
recordkeeper recordkeeping
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 SUMMARY: The Food and Drug became effective. Hearing Protectors are
the recordkeeping provisions of Administration (FDA) is announcing an currently regulated under the heading,
§ 179.25(e) on our experience regulating amendment to the notice of meeting of ‘‘Protector, Hearing (Insert),’’ Product
the safe use of radiation as a direct food the Ear, Nose, and Throat Devices Panel Code EWD, as unclassified under the
additive. The number of firms who of the Medical Devices Advisory 510(k) premarket notification authority.
process food using irradiation is Committee. This meeting was Circumaural Hearing Protectors are
extremely limited. We estimate that announced in the Federal Register of currently regulated under the heading,
there are four irradiation plants whose March 13, 2015. The amendment is ‘‘Protector, Hearing (Circumaural),’’
business is devoted primarily (i.e., being made to reflect a change in the Product Code EWE, as unclassified
approximately 100 percent) to April 30th Agenda portion of the under the 510(k) premarket notification
irradiation of food and other agricultural document. There are no other changes. authority. Tactile Hearing Aid Devices
products. Four other firms also irradiate FOR FURTHER INFORMATION CONTACT: are currently regulated under the
small quantities of food. We estimate Patricio Garcia, Center for Devices and heading, ‘‘Hearing Aid, Tactile,’’
that this irradiation accounts for no Radiological Health, Food and Drug Product Code LRA, as unclassified
more than 10 percent of the business for Administration, 10903 New Hampshire under the 510(k) premarket notification
each of these firms. Therefore, the Ave., Bldg. 66, Rm. 1535, Silver Spring authority. Speech Training Aids for the
average estimated burden is based on MD 20993–0002, patricio.garcia@ Hearing Impaired (Battery Powered or
four facilities devoting 100 percent of fda.hhs.gov, 301–796–6875, or FDA Non-Patient) are currently regulated
their business to food irradiation (4 × Advisory Committee Information Line, under the heading, ‘‘Aids, Speech
300 hours = 1200 hours for 1–800–741–8138 (301–443–0572 in the Training For The Hearing Impaired
recordkeeping annually), and four Washington DC area), code EN. Please (Battery-Operated or Non-Patient),’’
facilities devoting 10 percent of their call the Information Line for up-to-date Product Code LFA, as unclassified
business to food irradiation (4 × 30 information on this meeting. under the 510(k) premarket notification
hours = 120 hours for recordkeeping SUPPLEMENTARY INFORMATION: In the authority. Speech Training Aids for the
annually). Federal Register of March 13, 2015 (80 Hearing Impaired (AC-Powered and
No burden has been estimated for the FR 13392), FDA announced that a Patient-Contact) are currently regulated
labeling requirements in §§ 179.21(b)(1), meeting of the Ear, Nose, and Throat under the heading, ‘‘Aids, Speech
179.21(b)(2), and 179.26(c) because the Devices Panel of the Medical Devices Training For The Hearing Impaired (AC-
information to be disclosed is Advisory Committee would be held on Powered and Patient-Contact),’’ Product
information that has been supplied by April 30 and May 1, 2015. On page Code LEZ, as unclassified under the
FDA. Under 5 CFR 1320.3(c)(2), the 13393, in the first and second columns, 510(k) premarket notification authority.
public disclosure of information the Agenda portion of the document is Vestibular Analysis Apparatuses are
originally supplied by the Federal changed to read as follows:
currently regulated under the heading,
Government to the recipient for the On April 30, 2015, the Agency is
adding three Agenda items to the ‘‘Apparatus, Vestibular Analysis,’’
purpose of disclosure to the public is
original five agenda items posted in the Product Code LXV, as unclassified
not subject to review by the Office of
March 13, 2015, Federal Register under the 510(k) premarket notification
Management and Budget under the
document. The three additional items authority. Middle Ear Inflation Devices
Paperwork Reduction Act.
are: Speech Training Aids for the are currently regulated under the
Dated: March 23, 2015. heading, ‘‘Device, Inflation, Middle
Hearing Impaired (Battery Powered or
Leslie Kux, Ear,’’ Product Code MJV, as unclassified
Non-Patient), Speech Training Aids for
Associate Commissioner for Policy. the Hearing Impaired (AC-powered and under the 510(k) premarket notification
[FR Doc. 2015–07263 Filed 3–30–15; 8:45 am] Patient-Contact), and Nasal Septal authority. Nasal Septal Button Devices
BILLING CODE 4164–01–P Button Devices. The committee will are currently regulated under the
discuss and make recommendations heading, ‘‘Button, Nasal Septal,’’
regarding the classification of Hearing Product Code LFB, as unclassified
DEPARTMENT OF HEALTH AND Protectors, Circumaural Hearing under the 510(k) premarket notification
HUMAN SERVICES Protectors, Tactile Hearing Aids, Speech authority. FDA is seeking committee
Training Aids for the Hearing Impaired input on the risks, safety and
Food and Drug Administration (Battery Powered or Non-Patient), effectiveness, and the regulatory
Speech Training Aids for the Hearing classification of Hearing Protectors,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[Docket No. FDA–2015–N–0001]
Impaired (AC-powered and Patient- Circumaural Hearing Protectors, Tactile
Ear, Nose, and Throat Devices Panel of Contact), Vestibular Analysis, Middle Hearing Aids, Speech Training Aids for
the Medical Devices Advisory Ear Inflation Devices, and Nasal Septal the Hearing Impaired (Battery Powered
Committee; Amendment of Notice Button Devices. These devices are or Non-Patient), Speech Training Aids
AGENCY: Food and Drug Administration, considered preamendments devices for the Hearing Impaired (AC-Powered
HHS. since they were in commercial and Patient-Contact), Vestibular
distribution prior to May 28, 1976, Analysis, Middle Ear Inflation Devices,
ACTION: Notice.
when the Medical Devices Amendments and Nasal Septal Button Devices.
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Document Created: 2015-12-18 11:48:29
Document Modified: 2015-12-18 11:48:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by June 1, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 17055 |
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