Agency Information Collection Activities; Submission for Office of Management and Budget Review; Irradiation in the Production, Processing, and Handling of Food, 15863-15864 [05-6086]
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15863
Federal Register / Vol. 70, No. 59 / Tuesday, March 29, 2005 / Notices
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
grjohnson@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
ACTION:
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 April 28,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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 179.21 (OMB Control Number
0910–0549)—Extension
Under section 409(a) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 348(a)), the use of a food
additive is deemed unsafe unless it
conforms to the terms of a regulation
prescribing its use, or to an exemption
for investigational use, or in the case of
a food additive that is a food contact
substance, there is in effect a regulation
prescribing the conditions under which
such additive may be safely used or a
notification that is effective. In response
to a petition that is submitted under
section 409 of the act to establish that
a food additive is safe, the agency may
either: (1) By order establish a
regulation (whether or not in accord
with that proposed by the petitioner)
Dated: March 23, 2005
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–6170 Filed 3–28–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0554]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Irradiation in the Production,
Processing, and Handling of Food
AGENCY:
Notice.
Food and Drug Administration,
HHS.
prescribing, with respect to one or more
proposed uses of the food additive
involved, the conditions under which
such additive may be safely used
(including, but not limited to,
specifications as to the particular food
or classes of food in or on which such
additive may be used, the maximum
quantity which may be used or
permitted to remain in or on such food,
the manner in which such additive may
be added to or used in or on such food,
and any directions or other labeling or
packaging requirements for such
additive deemed necessary by him to
assure the safety of such use), and shall
notify the petitioner of such order and
the reasons for such action; or (2) by
order deny the petition and notify the
petitioner of such order and of the
reasons for such action.
In response to a petition filed by
Science Applications International
Corp., who subsequently transferred
their rights to the petition to Ancore
Corp., FDA published in the Federal
Register of December 21, 2004, a
document that amended 21 CFR 179.21
to provide for the use of sources of
monoenergetic neutrons to inspect cargo
containers that may contain food. Under
this regulation, monoenergetic neutron
sources producing neutrons at energies
not less than 1 million electron volts
(MeV) but no greater than 14 MeV may
be used for inspection of cargo
containers that may contain food,
providing that the neutron source bears
a label stating the minimum and
maximum energy of radiation emitted
by the source. The regulation also
requires that the label or accompanying
labeling bear adequate directions for
safe use and a statement that no food
shall be exposed to this radiation source
so as to receive a dose in excess of 0.01
gray. FDA has determined that this
information is needed to assure safe use
of the source of radiation.
In the Federal Register of January 4,
2005 (70 FR 366), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Number of
Respondents
179.21(a)(5) and (b)(2)(v)
1There
Annual
Frequency
Per Response
1
Total Annual
Responses
1
1
Total
Operating and
aintenance
Costs
Hours Per
Response
1
$100
are no capital costs associated with this collection of information.
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Total Hours
1
15864
Federal Register / Vol. 70, No. 59 / Tuesday, March 29, 2005 / Notices
FDA estimates that the burden will be
insignificant because the reporting
requirement reflects customary business
practice. Based on discussions with an
industry representative, the burden
hours estimated for this collection of
information is 1 hour. The operating
and maintenance cost associated with
this collection is $100 for preparation of
labels.
Dated: March 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–6086 Filed 3–28–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0534]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Format and
Content for Over-the-Counter Drug
Product Labeling
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
(the PRA).
DATES: Fax written comments on the
collection of information by April 28,
2005.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
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.
ADDRESSES:
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17:01 Mar 28, 2005
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Format and Content for Over-theCounter (OTC) Drug Product Labeling—
(OMB Control Number 0910–0340)—
Extension
In the Federal Register of March 17,
1999 (64 FR 13254), FDA amended its
regulations governing requirements for
human drug products to establish a
standardized format for the labeling of
all over-the-counter (OTC) drug
products. The rule added new § 201.66
(21 CFR 201.66) and requires OTC drug
product labeling to include uniform
headings and subheadings, presented in
a standardize order, with minimum
standards for type size and other
graphic features. The rule is intended to
enable consumers to better read and
understand OTC drug product labeling
and to apply this information to the safe
and effective use of OTC drug products.
FDA concludes that the labeling
statements required under this rule are
not subject to review by the OMB
because they are ‘‘a public disclosure of
information originally supplied by the
Federal government to the recipient for
the purpose of disclosure to the public’’
(5 CFR 1320.3(c)(2)) and therefore do
not constitute a ‘‘collection of
information’’ under the PRA (44 U.S.C.
3501 et seq.).
Section 201.66 of the labeling
requirements requires all OTC drug
manufacturers to format labeling as set
forth in paragraphs (c) and (d). FDA has
learned from the industry that OTC drug
product manufacturers routinely
redesign the labeling of their products
as part of their usual and customary
business practice. The rule provides
varied timeframes for implementing the
OTC labeling requirements. Therefore,
the majority of respondents have been
able to format OTC drug product
labeling in accordance with § 201.66 as
part of their routine redesign practice,
creating no additional paperwork or
economic burden.
In discussing the collection of
information under the PRA in the final
rule (64 FR 13254 at 13274 to 13276),
FDA estimated that, of the 39,310 stock
keeping units (SKUs) (individual
products, packages, and sizes) marketed
under a final monograph when the OTC
labeling requirements were issued on
March 17, 1999, approximately 32
percent, or 12,573 products, may
necessitate labeling format changes
sooner than provided under their usual
and customary practice of label design.
FDA estimated that of the 400
respondents who produce OTC drug
products, including the 12,573 products
described above, each may be required
to respond approximately 31.4 times to
this rule outside of their usual and
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
customary practice. Each response was
estimated to take, on the average, 4
hours, for a total of 50,292 hours per
year. This burden was expected to be a
one-time burden.
FDA stated that although the usual
and customary practice of label redesign
would minimize the burden for the
remaining 68 percent of SKUs, or 26,737
products, marketed at the time the OTC
labeling requirements were issued on
March 17, 1999, additional time may be
necessary for each company to make the
format changes under this rule. FDA
estimated that of the 400 respondents
who produce OTC drug products, each
may be required to respond
approximately 66.8 times to bring the
26,737 products into compliance with
the rule. FDA estimated that for this
group, each response will take an
average of 2.5 hours for a total of 66,842
hours. This burden was expected to be
a one-time burden.
Finally, FDA estimated that
approximately 61 respondents hold new
drug applications (NDAs) and
abbreviated new drug applications
(ANDAs) (41 NDA holders and 20
ANDA holders) for which supplements
and amendments would be required.
FDA expected that 522 submissions
(350 to NDAs and 172 to ANDAs) would
be required for labeling changes under
§ 201.66(c) and (d), which averages to
8.5 submissions per respondent. FDA
estimated that each submission
wouldtake an average of 2 hours to
prepare for a total of 1,040 hours
annually. This burden was also
expected to be a one-time burden.
Since the final rule was issued on
March 17, 1999, FDA extended the May
16, 2001, compliance date by 1 year to
May 16, 2002 (with a corresponding
extension of the May 16, 2002,
compliance date for products with
annual sales of less than $25,000 to May
16, 2003) (65 FR 38191, June 20, 2000).
Since March 17, 1999, FDA has
published 6 additional major final rules
on OTC drug monographs and several
minor amendments to existing final
monographs. The effective date for
relabeling the OTC drug products
affected by these final monographs in
the new format occurred by the end of
2004, except for OTC sunscreen drug
products (for which implementation of
the new labeling requirements has been
stayed indefinitely while FDA amends
the monograph for these products) and
a small number of other OTC drug
products with annual sales less than
$25,000. Based on information in the 6
final rules issued since 1999, FDA
estimates that 11,250 additional SKUs
(out of the original 26,737 that needed
to be relabeled in the new format) have
E:\FR\FM\29MRN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 59 (Tuesday, March 29, 2005)]
[Notices]
[Pages 15863-15864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6086]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0554]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 April
28, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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
179.21 (OMB Control Number 0910-0549)--Extension
Under section 409(a) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 348(a)), the use of a food additive is deemed
unsafe unless it conforms to the terms of a regulation prescribing its
use, or to an exemption for investigational use, or in the case of a
food additive that is a food contact substance, there is in effect a
regulation prescribing the conditions under which such additive may be
safely used or a notification that is effective. In response to a
petition that is submitted under section 409 of the act to establish
that a food additive is safe, the agency may either: (1) By order
establish a regulation (whether or not in accord with that proposed by
the petitioner) prescribing, with respect to one or more proposed uses
of the food additive involved, the conditions under which such additive
may be safely used (including, but not limited to, specifications as to
the particular food or classes of food in or on which such additive may
be used, the maximum quantity which may be used or permitted to remain
in or on such food, the manner in which such additive may be added to
or used in or on such food, and any directions or other labeling or
packaging requirements for such additive deemed necessary by him to
assure the safety of such use), and shall notify the petitioner of such
order and the reasons for such action; or (2) by order deny the
petition and notify the petitioner of such order and of the reasons for
such action.
In response to a petition filed by Science Applications
International Corp., who subsequently transferred their rights to the
petition to Ancore Corp., FDA published in the Federal Register of
December 21, 2004, a document that amended 21 CFR 179.21 to provide for
the use of sources of monoenergetic neutrons to inspect cargo
containers that may contain food. Under this regulation, monoenergetic
neutron sources producing neutrons at energies not less than 1 million
electron volts (MeV) but no greater than 14 MeV may be used for
inspection of cargo containers that may contain food, providing that
the neutron source bears a label stating the minimum and maximum energy
of radiation emitted by the source. The regulation also requires that
the label or accompanying labeling bear adequate directions for safe
use and a statement that no food shall be exposed to this radiation
source so as to receive a dose in excess of 0.01 gray. FDA has
determined that this information is needed to assure safe use of the
source of radiation.
In the Federal Register of January 4, 2005 (70 FR 366), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total Annual Hours Per Operating and
21 CFR Section Respondents FrequencyPer Responses Response Maintenance Total Hours
Response Costs
---------------------------------------------------------------------------------------------------------------------------------------------
179.21(a)(5) and (b)(2)(v) 1 1 1 1 $100 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs associated with this collection of information.
[[Page 15864]]
FDA estimates that the burden will be insignificant because the
reporting requirement reflects customary business practice. Based on
discussions with an industry representative, the burden hours estimated
for this collection of information is 1 hour. The operating and
maintenance cost associated with this collection is $100 for
preparation of labels.
Dated: March 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6086 Filed 3-28-05; 8:45 am]
BILLING CODE 4160-01-S
