Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling, 49495-49497 [2010-19985]
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Federal Register / Vol. 75, No. 156 / Friday, August 13, 2010 / Notices
Centers for Medicare and Medicaid
Services, and is depended on to help
manage the program. Being able to
examine various characteristics and to
chart evolving trends offers policy
makers a reliable tool for making
informed decisions. The MCBS is used
to identify potential new policy
direction or modifications to the
Medicare program and once those
program enhancements are
implemented, monitor the impact of
those changes. The central goals of the
MCBS are to determine medical care
expenditures and sources of payment
for all services, including copayments,
deductibles, and non-covered services;
to ascertain all types of health insurance
coverage and relate coverage to actual
payments; and to trace processes over
time, such as changes in health status,
spending down to Medicaid eligibility,
and the impacts of program changes.
Form Number: CMS–P–0015A (OMB#:
0938–0568); Frequency: Yearly; Affected
Public: Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 16,217 Total Annual
Responses: 48,650; Total Annual Hours:
57,062 (For policy questions regarding
this collection contact William Long at
410–786–7927. For all other issues call
410–786–1326.)
5. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare Health
Outcomes Survey (HOS); Use: CMS has
a responsibility to its Medicare
beneficiaries to require that care
provided by managed care organizations
under contract with CMS is of high
quality. One way of ensuring high
quality care in Medicare Managed Care
Organizations (MCOs), or more
commonly referred to as Medicare
Advantage Organizations (MAOs), is
through the development of
standardized, uniform performance
measures to enable CMS to gather the
data needed to evaluate the care
provided to Medicare beneficiaries.
The goal of the Medicare HOS
program is to gather valid, reliable,
clinically meaningful health status data
in Medicare managed care for use in
quality improvement activities, plan
accountability, public reporting, and
improving health. All managed care
plans with Medicare Advantage (MA)
contracts must participate. CMS, in
collaboration with the National
Committee for Quality Assurance
(NCQA), launched the Medicare HOS as
part of the Effectiveness of Care
component of the former Health Plan
Employer Data and Information Set,
now known as the Healthcare
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Effectiveness Data and Information Set
(HEDIS®).
The HOS measure was developed
under the guidance of a Technical
Expert Panel comprised of individuals
with specific expertise in the health care
industry and outcomes measurement.
The measure includes the most recent
advances in summarizing physical and
mental health outcomes results and
appropriate risk adjustment techniques.
In addition to health outcomes
measures, the HOS is used to collect the
Management of Urinary Incontinence in
Older Adults, Physical Activity in Older
Adults, Fall Risk Management, and
Osteoporosis Testing in Older Women
HEDIS® measures. The collection of
Medicare HOS is necessary to hold
Medicare managed care contractors
accountable for the quality of care they
are delivering. This reporting
requirement allows CMS to obtain the
information necessary for proper
oversight of the Medicare Advantage
program. Form Number: CMS–10203
(OMB#: 0938–0701); Frequency: Yearly;
Affected Public: Individuals and
households; Number of Respondents:
1,099,560 Total Annual Responses:
1,099,560; Total Annual Hours: 366,520
(For policy questions regarding this
collection contact Chris Haffer at 410–
786–8764. For all other issues call 410–
786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on September 13, 2010.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov.
Dated: August 6, 2010.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2010–19756 Filed 8–12–10; 8:45 am]
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49495
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0248]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Format and
Content Requirements for Over-theCounter Drug Product Labeling
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 September
13, 2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0340. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@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.
SUMMARY:
Format and Content Requirements for
Over-the-Counter Drug Product
Labeling—OMB Control Number 0910–
0340—Reinstatement
In the Federal Register of March 17,
1999 (64 FR 13254) (the 1999 labeling
final rule), we amended our regulations
governing requirements for human drug
products to establish standardized
format and content requirements for the
labeling of all marketed over-thecounter (OTC) drug products in part 201
(21 CFR part 201). The regulations in
part 201 require OTC drug product
labeling to include uniform headings
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13AUN1
49496
Federal Register / Vol. 75, No. 156 / Friday, August 13, 2010 / Notices
and subheadings, presented in a
standardized order, with minimum
standards for type size and other
graphical features. Specifically, the 1999
labeling final rule added new § 201.66.
Section 201.66 sets content and format
requirements for the Drug Facts portion
of labels on OTC drug products.
The only burden to comply with the
regulations in part 201 is a one-time
burden for the following products:
• New OTC drug products introduced
to the marketplace under new drug
applications (NDAs), abbreviated new
drug applications (ANDAs), or an OTC
drug monograph, except for products in
‘‘convenience size’’ packages1
• OTC sunscreen products.
The burden is limited to these
products because, as explained in this
document, most currently marketed
OTC drug products are already required
to be in compliance with these labeling
regulations, and thus will incur no
further burden in order to satisfy this
regulation. We recognize that some
manufacturers may choose to modify
labeling already required to be in Drug
Facts format. We believe that such
changes are usual and customary as part
of routine redesign practice, and thus do
not create additional burden within the
meaning of the PRA. With the
exceptions described, new products
must comply with the regulations as
they are introduced to the marketplace.
Also, as explained in this document,
OTC sunscreen products have not been
required to comply with these
regulations but are anticipated to
become subject to these requirements
when a sunscreen final rule becomes
effective.
Specifically, on June 20, 2000 (65 FR
38191), we published a Federal Register
document that required all OTC drug
products marketed under the OTC
monograph system except sunscreen
products to comply with the regulations
by May 16, 2005, or sooner (65 FR
38191 at 38193). Sunscreen products do
not have to comply with the regulations
until we lift the stay of the sunscreen
final rule that was published in the
Federal Register of May 21, 1999 (64 FR
27666) (the 1999 sunscreen final rule).
In the Federal Register of December 31,
2001 (66 FR 67485), we stayed the 1999
sunscreen final rule indefinitely. In the
Federal Register of September 3, 2004
(69 FR 53801), we delayed the § 201.66
implementation date for OTC sunscreen
products indefinitely, pending future
rulemaking to amend the substance of
labeling for these products. In the
Federal Register of August 27, 2007 (72
FR 49070), we proposed changes to
labeling and related testing
requirements for sunscreen products to
address both ultraviolet A and
ultraviolet B radiation, and anticipated
that sunscreen products would become
subject to § 201.66 at the time any
resultant final rule becomes effective.
Based on a recent estimate provided
by the Consumer Healthcare Products
Association (CHPA),2 we believe that
approximately 900 new OTC drug
product stock keeping units (SKUs) are
introduced to the marketplace each
year. Further, we estimate that these
SKUs are marketed by 300
manufacturers. We estimate that the
preparation of labeling for new OTC
drug products will require 5 hours to
prepare, complete, and review prior to
submitting the new labeling to us. Based
on this estimate, the annual reporting
burden for this type of labeling is
approximately 4,500 hours. (See table 1
of this document.)
We estimate that there are 4,752 OTC
sunscreen drug product SKUs that have
not yet complied with the 1999 labeling
final rule. All of these SKUs will need
to implement the new labeling format
by the implementation date included in
a sunscreen final rule when it is
published in the Federal Register. We
estimate that these 4,752 SKUs are
marketed by 400 manufacturers and that
approximately 2 hours will be spent on
each submission. (See table 1 of this
document.) The number of hours per
submission (response) is based on our
estimate in the 1999 labeling final rule
(64 FR 13254 at 13276). If an average of
2 hours is spent preparing, completing,
and reviewing each of the estimated
4,752 sunscreen SKUs, the total number
of hours dedicated to the labeling of
OTC sunscreen products would be 9,504
hours (4,752 SKUs times 2 hours/SKU).
(See table 1 of this document.)
In determining the burden for
§ 201.66, it is also important to consider
exemptions or deferrals of the regulation
allowed products under § 201.66(e).
Since publication of the 1999 labeling
final rule, we have received only one
request for exemption or deferral. One
response over an 8-year period equates
to an annual frequency of response
equal to 0.125. In the 1999 labeling final
rule, we estimated that a request for
deferral or exemption would require 24
hours to complete (64 FR 13254 at
13276). We continue to believe that this
type of response will require
approximately 24 hours. Multiplying
the annual frequency of response (0.125)
by the number of hour per response (24)
gives a total response time for
requesting exemption or deferral equal
to 3 hours.
In the Federal Register of June 3, 2010
(75 FR 31448), we published a 60-day
notice requesting public comment on
the proposed collection of information.
We received no comments.
We estimate the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
201.66(c) and (d)2
400
201.66(c) and (d)3
300
201.66(e)
Total Annual
Responses
11.88
9,504
900
5
4,500
0.125
0.125
2
24
3
Total
emcdonald on DSK2BSOYB1PROD with NOTICES
Total Hours
4,752
3
1
Hours per
Response
14,007
1 We
estimate that capital costs of 22 to 25 million dollars will result from preparing labeling content and format in accordance with § 201.66.
There are no operating or maintenance costs associated with this collection of information.
1 In a final rule published in the Federal Register
of April 5, 2002 (67 FR 16304), the agency delayed
the compliance dates for the 1999 labeling final rule
for all OTC drug products that: (1) Contain no more
than two doses of an OTC drug; and (2) because of
their limited available labeling space, would require
more than 60 percent of the total surface area
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available to bear labeling to meet the requirements
set forth in § 201.66(d)(1) and (d)(9) and, therefore,
qualify for the labeling modifications currently set
forth in § 201.66(d)(10) (67 FR 16304 at 16306). The
agency issued this delay in order to develop
additional rulemaking for these ‘‘convenience size’’
products (December 12, 2006, 71 FR 74474). These
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products are not currently subject to the
requirements of § 201.66. PRA approval for any
requirements to which they may be subject in the
future will be handled in a separate rulemaking.
2 Letter submitted to FDA by CHPA on March 1,
2010 (available in Docket No. FDA–2010–N–0248).
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Federal Register / Vol. 75, No. 156 / Friday, August 13, 2010 / Notices
2 Burden
3 Burden
for manufacturers of sunscreen drug products.
for manufacturers of new OTC drug products.
Dated: August 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–19985 Filed 8–12–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0305]
John Bonnes: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the act) debarring John
Bonnes for a period of 5 years from
importing articles of food or offering
such articles for importation into the
United States. FDA bases this order on
a finding that Mr. Bonnes was convicted
of a felony under Federal law for
conduct relating to the importation into
the United States of an article of food.
Mr. Bonnes has notified FDA that he
acquiesces to debarment, and therefore
has waived his opportunity for a hearing
concerning this action.
DATES: This order is effective April 19,
2010.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Division of Compliance
Policy (HFC–230), Office of
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 240–632–6844.
SUPPLEMENTARY INFORMATION:
SUMMARY:
emcdonald on DSK2BSOYB1PROD with NOTICES
49497
I. Background
Section 306(b)(1)(C) of the act (21
U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such article for
import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the act (21 U.S.C.
335a(b)(3)(A)), that the individual has
been convicted of a felony under
Federal law for conduct relating to the
importation into the United States of
any food. Section 306(l)(1)(C) of the act
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16:35 Aug 12, 2010
Jkt 220001
(21 U.S.C. 335a(l)(1)(C)) provides that,
for purposes of section 306, a person is
considered to have been convicted of a
criminal offense ‘‘when the person has
entered into participation in a first
offender, deferred adjudication, or other
similar arrangement or program where
judgment of conviction has been
withheld.’’
On April 17, 2010, Mr. Bonnes
entered into a deferred prosecution
agreement with the United States
Attorney’s Office, Eastern District of
New York. FDA’s finding that
debarment is appropriate is based on the
following facts, as set forth in the
deferred prosecution agreement.
Between April 1, 2006, and August 1,
2006, Mr. Bonnes did knowingly and
willfully make materially false,
fictitious, and fraudulent statements and
representations, in a matter within the
jurisdiction of the executive branch of
the Government of the United States, in
violation of 18 U.S.C. 1001(a)(2).
Specifically, Mr. Bonnes’ company,
Ameritech Laboratories, provided
seventeen certificates of analysis to a
client certifying that fresh produce the
client wished to import into the United
States from the Dominican Republic was
free of any pesticides. Mr. Bonnes
signed each of the certificates of
analysis as the director of Ameritech
Laboratories.
Each of these certificates of analysis
was false. Although the certificates
stated that Ameritech Laboratories
performed pesticide tests on the
produce, Ameritech Laboratories did
not perform a chemical analysis to
certify that the produce was free of any
pesticides. Mr. Bonnes knew at the time
he prepared the certificates that they
were false, and he also knew that the
client intended to submit certificates to
FDA’s District Office in Queens, New
York, in support of importing the
produce into the United States for sale
as human food.
Mr. Bonnes’ actions and his deferred
prosecution agreement make him
subject to permissive debarment as
described under section 306(b)(3)(A) of
the act. Pursuant to the deferred
prosecution agreement, Mr. Bonnes
expressly acquiesced to permissive
debarment under section 306(b)(1)(C) of
the act for the conduct described in this
document. In accordance with section
306(c)(2)(B) of the act (21 U.S.C.
335a(c)(2)(B)), Mr. Bonnes notified FDA
of his acquiescence to debarment in a
letter dated April 19, 2010. A person
subject to debarment is entitled to an
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Sfmt 9990
opportunity for an agency hearing on
disputed issues of material fact under
section 306(i) of the act (21 U.S.C.
335a(i)), but by acquiescing to
debarment Mr. Bonnes waived his
opportunity for a hearing and to raise
any contentions concerning his
debarment. The maximum period of
debarment under section
306(c)(2)(A)(iii) of the act (21 U.S.C.
335a(c)(2)(A)(iii)) is 5 years. FDA
concludes that the nature and scope of
Mr. Bonnes’ conduct supports the
maximum possible period of debarment.
II. Findings and Order
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(b)(1)(C) of the
act, under authority delegated to the
Director (Staff Manual Guide 1410.35),
finds that Mr. John Bonnes has entered
into a deferred prosecution agreement as
the result of conduct relating to the
importation of an article of food into the
United States that makes him subject to
permissive debarment.
As a result of the foregoing finding,
Mr. Bonnes is debarred for a period of
5 years from importing articles of food
or offering such articles for import into
the United States, effective (see DATES).
Under section 301(cc) of the act (21
U.S.C. 331(cc)), the importing or
offering for import into the United
States of an article of food by, with the
assistance of, or at the direction of Mr.
Bonnes is a prohibited act.
Any application by Mr. Bonnes for
termination of debarment under section
306(d)(1) of the act should be identified
with Docket No. FDA–2010–N–0305
and sent to the Division of Dockets
Management (see ADDRESSES). All such
submissions are to be filed in four
copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: August 2, 2010.
Howard R. Sklamberg,
Director, Office of Enforcement, Office of
Regulatory Affairs.
[FR Doc. 2010–19981 Filed 8–12–10; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 75, Number 156 (Friday, August 13, 2010)]
[Notices]
[Pages 49495-49497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19985]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0248]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Format and Content
Requirements 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.
DATES: Fax written comments on the collection of information by
September 13, 2010.
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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0340.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@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.
Format and Content Requirements for Over-the-Counter Drug Product
Labeling--OMB Control Number 0910-0340--Reinstatement
In the Federal Register of March 17, 1999 (64 FR 13254) (the 1999
labeling final rule), we amended our regulations governing requirements
for human drug products to establish standardized format and content
requirements for the labeling of all marketed over-the-counter (OTC)
drug products in part 201 (21 CFR part 201). The regulations in part
201 require OTC drug product labeling to include uniform headings
[[Page 49496]]
and subheadings, presented in a standardized order, with minimum
standards for type size and other graphical features. Specifically, the
1999 labeling final rule added new Sec. 201.66. Section 201.66 sets
content and format requirements for the Drug Facts portion of labels on
OTC drug products.
The only burden to comply with the regulations in part 201 is a
one-time burden for the following products:
New OTC drug products introduced to the marketplace under
new drug applications (NDAs), abbreviated new drug applications
(ANDAs), or an OTC drug monograph, except for products in ``convenience
size'' packages\1\
---------------------------------------------------------------------------
\1\ In a final rule published in the Federal Register of April
5, 2002 (67 FR 16304), the agency delayed the compliance dates for
the 1999 labeling final rule for all OTC drug products that: (1)
Contain no more than two doses of an OTC drug; and (2) because of
their limited available labeling space, would require more than 60
percent of the total surface area available to bear labeling to meet
the requirements set forth in Sec. 201.66(d)(1) and (d)(9) and,
therefore, qualify for the labeling modifications currently set
forth in Sec. 201.66(d)(10) (67 FR 16304 at 16306). The agency
issued this delay in order to develop additional rulemaking for
these ``convenience size'' products (December 12, 2006, 71 FR
74474). These products are not currently subject to the requirements
of Sec. 201.66. PRA approval for any requirements to which they may
be subject in the future will be handled in a separate rulemaking.
---------------------------------------------------------------------------
OTC sunscreen products.
The burden is limited to these products because, as explained in
this document, most currently marketed OTC drug products are already
required to be in compliance with these labeling regulations, and thus
will incur no further burden in order to satisfy this regulation. We
recognize that some manufacturers may choose to modify labeling already
required to be in Drug Facts format. We believe that such changes are
usual and customary as part of routine redesign practice, and thus do
not create additional burden within the meaning of the PRA. With the
exceptions described, new products must comply with the regulations as
they are introduced to the marketplace. Also, as explained in this
document, OTC sunscreen products have not been required to comply with
these regulations but are anticipated to become subject to these
requirements when a sunscreen final rule becomes effective.
Specifically, on June 20, 2000 (65 FR 38191), we published a
Federal Register document that required all OTC drug products marketed
under the OTC monograph system except sunscreen products to comply with
the regulations by May 16, 2005, or sooner (65 FR 38191 at 38193).
Sunscreen products do not have to comply with the regulations until we
lift the stay of the sunscreen final rule that was published in the
Federal Register of May 21, 1999 (64 FR 27666) (the 1999 sunscreen
final rule). In the Federal Register of December 31, 2001 (66 FR
67485), we stayed the 1999 sunscreen final rule indefinitely. In the
Federal Register of September 3, 2004 (69 FR 53801), we delayed the
Sec. 201.66 implementation date for OTC sunscreen products
indefinitely, pending future rulemaking to amend the substance of
labeling for these products. In the Federal Register of August 27, 2007
(72 FR 49070), we proposed changes to labeling and related testing
requirements for sunscreen products to address both ultraviolet A and
ultraviolet B radiation, and anticipated that sunscreen products would
become subject to Sec. 201.66 at the time any resultant final rule
becomes effective.
Based on a recent estimate provided by the Consumer Healthcare
Products Association (CHPA),\2\ we believe that approximately 900 new
OTC drug product stock keeping units (SKUs) are introduced to the
marketplace each year. Further, we estimate that these SKUs are
marketed by 300 manufacturers. We estimate that the preparation of
labeling for new OTC drug products will require 5 hours to prepare,
complete, and review prior to submitting the new labeling to us. Based
on this estimate, the annual reporting burden for this type of labeling
is approximately 4,500 hours. (See table 1 of this document.)
---------------------------------------------------------------------------
\2\ Letter submitted to FDA by CHPA on March 1, 2010 (available
in Docket No. FDA-2010-N-0248).
---------------------------------------------------------------------------
We estimate that there are 4,752 OTC sunscreen drug product SKUs
that have not yet complied with the 1999 labeling final rule. All of
these SKUs will need to implement the new labeling format by the
implementation date included in a sunscreen final rule when it is
published in the Federal Register. We estimate that these 4,752 SKUs
are marketed by 400 manufacturers and that approximately 2 hours will
be spent on each submission. (See table 1 of this document.) The number
of hours per submission (response) is based on our estimate in the 1999
labeling final rule (64 FR 13254 at 13276). If an average of 2 hours is
spent preparing, completing, and reviewing each of the estimated 4,752
sunscreen SKUs, the total number of hours dedicated to the labeling of
OTC sunscreen products would be 9,504 hours (4,752 SKUs times 2 hours/
SKU). (See table 1 of this document.)
In determining the burden for Sec. 201.66, it is also important to
consider exemptions or deferrals of the regulation allowed products
under Sec. 201.66(e). Since publication of the 1999 labeling final
rule, we have received only one request for exemption or deferral. One
response over an 8-year period equates to an annual frequency of
response equal to 0.125. In the 1999 labeling final rule, we estimated
that a request for deferral or exemption would require 24 hours to
complete (64 FR 13254 at 13276). We continue to believe that this type
of response will require approximately 24 hours. Multiplying the annual
frequency of response (0.125) by the number of hour per response (24)
gives a total response time for requesting exemption or deferral equal
to 3 hours.
In the Federal Register of June 3, 2010 (75 FR 31448), we published
a 60-day notice requesting public comment on the proposed collection of
information. We received no comments.
We estimate the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
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201.66(c) and (d)\2\ 400 11.88 4,752 2 9,504
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201.66(c) and (d)\3\ 300 3 900 5 4,500
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201.66(e) 1 0.125 0.125 24 3
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Total 14,007
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\1\ We estimate that capital costs of 22 to 25 million dollars will result from preparing labeling content and format in accordance with Sec. 201.66.
There are no operating or maintenance costs associated with this collection of information.
[[Page 49497]]
\2\ Burden for manufacturers of sunscreen drug products.
\3\ Burden for manufacturers of new OTC drug products.
Dated: August 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19985 Filed 8-12-10; 8:45 am]
BILLING CODE 4160-01-S
