80 FR 43782 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 141 (July 23, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 141 (July 23, 2015)
| Page Range | 43782-43784 | |
| FR Document | 2015-18026 |
[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)] [Notices] [Pages 43782-43784] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18026] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0449] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the- Counter Sunscreen Drug Products 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 August 24, 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 [email protected]. All comments should be identified with the OMB control number 0910-0717. 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 Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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. SPF Labeling and Testing Requirements for OTC Sunscreen Products Containing Specified Active Ingredients and Marketed Without Approved Applications, and Drug Facts Labeling for All OTC Sunscreen Products-- 21 CFR 201.327(a)(1) and (i), 21 CFR 201.66(c) and (d) (OMB Control Number 0910-0717)--Extension In the Federal Register of June 17, 2011 (76 FR 35620), we published a final rule establishing labeling and effectiveness testing requirements for certain OTC sunscreen products containing specified active ingredients without approved applications (2011 sunscreen final rule; Sec. 201.327 (21 CFR 201.327)). In addition to establishing testing requirements, this sunscreen final rule lifts the delay of implementation of the prior 1999 sunscreen final rule (published May 21, 1999, at 64 FR 27666 and stayed December 31, 2001, 66 FR 67485) from complying with the 1999 labeling final rule (published March 17, 1999, 64 FR 13254) in which we amended our regulations governing requirements for human drug products to establish standardized format and content requirements for the labeling of all marketed OTC drug products in part 201 (21 CFR part 201). Specifically, the 1999 labeling final rule added new Sec. 201.66 to part 201. Section 201.66 sets content and format requirements for the Drug Facts portion of labels on OTC drug products. We specifically exempted OTC sunscreen products from complying with the 1999 labeling final rule until we lifted the stay of the 1999 sunscreen final rule. The 2011 sunscreen final rule became effective December 17, 2012, for sunscreen products with annual sales of $25,000 or more and December 17, 2013, for sunscreen products with annual sales of less than $25,000 when we published an extension date notice on May 11, 2012 (77 FR 27591). SPF Labeling and Testing for OTC Sunscreens Containing Specified Active Ingredients and Marketed Without Approved Applications In the Federal Register of June 17, 2011 (76 FR 35678), we published a 60-day notice requesting public comment on the proposed collection of information in regard to SPF labeling and testing requirements for OTC sunscreen products containing specified ingredients and marketed without approved applications. In that notice, we stated that Sec. 201.327 (a)(1) requires the principal display panel (PDP) labeling of a sunscreen covered by the 2011 final rule to include the SPF value determined by conducting the SPF test outlined in Sec. 201.327(i). Therefore, this provision results in information collection with a third-party disclosure burden for manufacturers of OTC sunscreens covered by the rule. We determined that products need only complete the testing and labeling required by the rule one time, and then continue to utilize the resultant labeling (third-party disclosure) going forward without additional burden. This one-time testing would need to be conducted within the first 3 years after publication of the 2011 final rule for all [[Page 43783]] OTC sunscreens covered by that rule. We determined that the third-party disclosure burden by manufacturers of OTC sunscreens covered by the rule was based on an estimate: (1) Of the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information; (2) on the conduct of SPF testing based on the estimated number of existing formulations; (3) of the time to relabel currently marketed OTC sunscreens containing specified ingredients and marketed without approved applications; and (4) on testing and labeling of new products introduced each year. The estimate for this burden in the 2011 60-day PRA notice was a total of 30,066 hours in years one and two and a total burden of 966 in each subsequent year. All currently marketed OTC sunscreen drug products are required at this time to be in compliance with the SPF labeling requirements specified by the 2011 final rule. However, our original estimate included the burden of new products introduced each year. We estimated that as many as 60 new OTC sunscreen products stock keeping units (SKUs) may be introduced each year which will have to be tested and labeled with the SPF value determined in the test. We estimated that the 60 new sunscreen SKUs represent 39 new formulations. The burden for testing and labeling these formulations was estimated at 30 hours per year. We have received no further comments on our estimate of burden for the collection of this information other than two comments (FDA-2011-N- 0449-0002 and FDA-2011-N-0449-0003). These comments were already addressed in FDA's notice of ``Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products'' published on May 9, 2012 (77 FR 27230). In the Federal Register of April 16, 2015 (80 FR 20499), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- No. of Activity No. of disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure ---------------------------------------------------------------------------------------------------------------- Conduct SPF testing in 20 1.95 39 24.............. 936 accordance with Sec. 201.327(i) for new sunscreens. Create PDP labeling in 20 3 60 0.5............. 30 accordance with Sec. (30 min.)....... 201.327(a)(1) for new sunscreen SKUs. Total................... .............. ................ .............. ................ 966 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Drug Facts Labeling for OTC Sunscreens Because the 2011 final rule also lifts the delay of implementation of the Drug Facts regulations (Sec. 201.66) for OTC sunscreens, the rule also modifies the information collection associated with Sec. 201.66 (currently approved under OMB control number 0910-0340) and adds an additional third-party disclosure burden resulting from requiring OTC sunscreen products to comply with Drug Facts regulations. In the Federal Register of March 17, 1999 (64 FR 13254), we amended our regulations governing requirements for human drug products to establish standardized format and content requirements for the labeling of all marketed OTC drug products, codified in Sec. 201.66 (the 1999 Drug Facts labeling final rule). Section 201.66 sets requirements for the Drug Facts portion of labels on OTC drug products, requiring such labeling to include uniform headings and subheadings, presented in a standardized order, with minimum standards for type size and other graphical features. Therefore, currently marketed OTC sunscreen products will incur a one-time burden to comply with the requirements in Sec. 201.66(c) and (d). The burden was estimated in the 60-day PRA notice published in the Federal Register of June 17, 2011 (76 FR 35678), as 43,200 hours for existing sunscreen SKUs and 720 hours for new sunscreen SKUs. The compliance dates for the 2011 final rule lifting the delay of the Sec. 201.66 labeling implementation data for OTC sunscreen products were December 17, 2012, for sunscreen products with annual sales of $25,000 or more and December 17, 2013, for sunscreen products with annual sales of less than $25,000, respectively, when we published an extension date notice on May 11, 2012 (77 FR 27591). All currently marketed sunscreen products are, therefore, already required to be in compliance with the Drug Facts labeling requirements in Sec. 201.66 and will incur no further burden in the 1999 labeling final rule. However, new OTC sunscreen drug products will be subject to a one-time burden to comply with Drug Facts labeling requirements in Sec. 201.66. In the 2011 60-day PRA, we estimated that as many as 60 new product SKUs marketed each year will have to comply with Drug Facts regulations. We estimated that these 60 SKUs would be marketed by 30 manufacturers. We estimated that approximately 12 hours would be spent on each label, based on the most recent estimate used for other OTC drug products to comply with the Drug Facts labeling final rule, including public comments received on this estimate in 2010 that addressed sunscreens. This is equal to 720 hours annually (60 SKUs x 12 hours/SKU). We stated that we do not expect any OTC sunscreens to apply for exemptions or deferrals of the Drug Facts regulations in Sec. 201.66(e). However, we took this into consideration in 2013 and estimated the burden for an exemption or deferral by considering the number of exemptions or deferrals we have received since publication of the 1999 final rule (one response) and estimating that a request for deferral or exemption would require 24 hours to complete. Multiplying the annual frequency of response (0.125) by the number of hours per response (24) gives a total response time for requesting an exemption or deferral equal to 3 hours. We estimate the burden of this collection of information as follows: [[Page 43784]] Table 2--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- No. of Activity No. of disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure ---------------------------------------------------------------------------------------------------------------- Format labeling in 20 3 60 12.............. 720 accordance with Sec. 201.66(c) and (d) for new sunscreen SKUs. Request for Drug Facts 1 0.125 0.125 24.............. 3 exemption or deferral Sec. 201.66(e). Total................... .............. ................ .............. ................ 723 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated:` July 17, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-18026 Filed 7-22-15; 8:45 am] BILLING CODE 4164-01-P
![43782 Federal Register / Vol. 80, No. 141 / Thursday, July 23, 2015 / Notices
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND containing specified active ingredients
HUMAN SERVICES HUMAN SERVICES without approved applications (2011
sunscreen final rule; § 201.327 (21 CFR
Food and Drug Administration Food and Drug Administration 201.327)). In addition to establishing
[Docket No. FDA–2011–N–0449] testing requirements, this sunscreen
[Docket No. FDA–2007–D–0369] final rule lifts the delay of
Agency Information Collection implementation of the prior 1999
Product-Specific Bioequivalence Activities; Submission for Office of sunscreen final rule (published May 21,
Recommendations; Draft and Revised Management and Budget Review; 1999, at 64 FR 27666 and stayed
Draft Guidances for Industry; Comment Request; Sun Protection December 31, 2001, 66 FR 67485) from
Availability; Correction Factor Labeling and Testing complying with the 1999 labeling final
Requirements and Drug Facts Labeling rule (published March 17, 1999, 64 FR
AGENCY: Food and Drug Administration, for Over-the-Counter Sunscreen Drug 13254) in which we amended our
HHS. Products regulations governing requirements for
human drug products to establish
ACTION: Notice; correction. AGENCY: Food and Drug Administration, standardized format and content
HHS. requirements for the labeling of all
SUMMARY: The Food and Drug ACTION: Notice. marketed OTC drug products in part 201
Administration (FDA) is correcting a (21 CFR part 201). Specifically, the 1999
SUMMARY: The Food and Drug labeling final rule added new § 201.66
notice that appeared in the Federal
Administration (FDA) is announcing to part 201. Section 201.66 sets content
Register of June 30, 2015 (80 FR 37273).
that a proposed collection of and format requirements for the Drug
The document announced the information has been submitted to the
availability of additional draft and Facts portion of labels on OTC drug
Office of Management and Budget products. We specifically exempted
revised draft product-specific (OMB) for review and clearance under
bioequivalence (BE) recommendations. OTC sunscreen products from
the Paperwork Reduction Act of 1995. complying with the 1999 labeling final
The document was published with an DATES: Fax written comments on the rule until we lifted the stay of the 1999
incorrect table title and contents. This collection of information by August 24, sunscreen final rule. The 2011
document corrects those errors. 2015. sunscreen final rule became effective
FOR FURTHER INFORMATION CONTACT: Lisa ADDRESSES: To ensure that comments on December 17, 2012, for sunscreen
Granger, Office of Policy and Planning, the information collection are received, products with annual sales of $25,000 or
Food and Drug Administration, 10903 OMB recommends that written more and December 17, 2013, for
New Hampshire Ave., Bldg. 32, Rm. comments be faxed to the Office of sunscreen products with annual sales of
3330, Silver Spring, MD 20993–0002, Information and Regulatory Affairs, less than $25,000 when we published an
301–796–9115. OMB, Attn: FDA Desk Officer, FAX: extension date notice on May 11, 2012
202–395–7285, or emailed to oira_ (77 FR 27591).
SUPPLEMENTARY INFORMATION: In FR Doc. submission@omb.eop.gov. All
2015–16013, appearing in the Federal SPF Labeling and Testing for OTC
comments should be identified with the Sunscreens Containing Specified Active
Register of Tuesday, June 30, 2015, the OMB control number 0910–0717. Also Ingredients and Marketed Without
following corrections are made: include the FDA docket number found Approved Applications
1. On page 37274, in the first column, in brackets in the heading of this
document. In the Federal Register of June 17,
the title of table 2, ‘‘Table 2. Revised 2011 (76 FR 35678), we published a 60-
Draft Product-Specific BE FOR FURTHER INFORMATION CONTACT: FDA day notice requesting public comment
Recommendations for Drug Products PRA Staff, Office of Operations, Food on the proposed collection of
Cholestyramine’’ is corrected to read and Drug Administration, 8455 information in regard to SPF labeling
‘‘Table 2. Revised Draft Product-Specific Colesville Rd., COLE–14526, Silver and testing requirements for OTC
BE Recommendations for Drug Spring, MD 20993–0002, PRAStaff@ sunscreen products containing specified
Products’’. fda.hhs.gov. ingredients and marketed without
2. On page 37274, in the first column, SUPPLEMENTARY INFORMATION: In approved applications. In that notice,
in the first line of the table under table compliance with 44 U.S.C. 3507, FDA we stated that § 201.327 (a)(1) requires
2, ‘‘Cholestyramine’’ is added to precede has submitted the following proposed the principal display panel (PDP)
‘‘Doxycycline hyclate, Prasugrel collection of information to OMB for labeling of a sunscreen covered by the
hydrochloride, Tiagabine review and clearance. 2011 final rule to include the SPF value
determined by conducting the SPF test
hydrochloride’’. SPF Labeling and Testing Requirements outlined in § 201.327(i). Therefore, this
Dated: July 17, 2015. for OTC Sunscreen Products Containing provision results in information
Leslie Kux,
Specified Active Ingredients and collection with a third-party disclosure
Marketed Without Approved burden for manufacturers of OTC
Associate Commissioner for Policy. Applications, and Drug Facts Labeling
[FR Doc. 2015–18024 Filed 7–22–15; 8:45 am]
sunscreens covered by the rule. We
for All OTC Sunscreen Products—21 determined that products need only
BILLING CODE 4164–01–P CFR 201.327(a)(1) and (i), 21 CFR
mstockstill on DSK4VPTVN1PROD with NOTICES
complete the testing and labeling
201.66(c) and (d) (OMB Control Number required by the rule one time, and then
0910–0717)—Extension continue to utilize the resultant labeling
In the Federal Register of June 17, (third-party disclosure) going forward
2011 (76 FR 35620), we published a without additional burden. This one-
final rule establishing labeling and time testing would need to be
effectiveness testing requirements for conducted within the first 3 years after
certain OTC sunscreen products publication of the 2011 final rule for all
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![43784 Federal Register / Vol. 80, No. 141 / Thursday, July 23, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
No. of Average
No. of Total annual
Activity disclosures per burden per Total hours
respondents disclosures
respondent disclosure
Format labeling in accordance with § 201.66(c) and (d) 20 3 60 12 ................. 720
for new sunscreen SKUs.
Request for Drug Facts exemption or deferral 1 0.125 0.125 24 ................. 3
§ 201.66(e).
Total ........................................................................... ........................ ............................ ........................ ...................... 723
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated:‘ July 17, 2015. titers on reporter cells, for multiple (2) that if within three (3) years from
Leslie Kux, strains of SIV based chimeric viruses the effective date of the Agreement,
Associate Commissioner for Policy. such that the results were not accurately Respondent receives or applies for PHS
[FR Doc. 2015–18026 Filed 7–22–15; 8:45 am] represented in: support, Respondent agreed that any
BILLING CODE 4164–01–P • Figure 7 in JVI 2013 institution employing her shall submit
• Figures 6B and 8C in R01 AI114367– in conjunction with each application for
01A1 PHS funds, or report, manuscript, or
DEPARTMENT OF HEALTH AND • Figures 1, 2B, and 3B in R01 abstract involving PHS-supported
HUMAN SERVICES AI120787–01 research in which Respondent is
• Figures 1A–D, 2D, 3D, 5A–C, 5I, 6C, involved, a certification to ORI that the
Office of the Secretary and S3D in the unpublished data provided by Respondent are based
manuscript on actual experiments or are otherwise
Findings of Research Misconduct legitimately derived, and that the data,
2. Respondent falsified and/or
AGENCY: Office of the Secretary, HHS. procedures, and methodology are
fabricated in vitro binding data of SIV
ACTION: Notice.
accurately reported in the application,
based chimeric viruses to human or
report, manuscript, or abstract; and
macaque CD4 such that the results were
SUMMARY: Notice is hereby given that (3) to exclude herself voluntarily from
not accurately represented in:
the Office of Research Integrity (ORI) serving in any advisory capacity to PHS
has taken final action in the following • Figure 6 in R01 AI120787–01 including, but not limited to, service on
case: • Figures 5D–F in the unpublished any PHS advisory committee, board,
Julia Bitzegeio, Ph.D., Aaron Diamond manuscript and/or peer review committee, or as a
AIDS Research Center: Based on the ADARC has submitted a request for consultant for a period of three (3) years,
Respondent’s admission, an assessment correction of JVI 2013. beginning on June 23, 2015.
conducted by the Aaron Diamond AIDS Dr. Bitzegeio has entered into a FOR FURTHER INFORMATION CONTACT:
Research Center (ADARC), and analysis Voluntary Settlement Agreement and Acting Director, Office of Research
conducted by ORI in its oversight has voluntarily agreed: Integrity, 1101 Wootton Parkway, Suite
review, ORI found that Dr. Julia (1) That if within three (3) years from 750, Rockville, MD 20852, (240) 453–
Bitzegeio, former Postdoctoral Fellow, the effective date of the Agreement, 8200.
ADARC, engaged in research Respondent receives or applies for U.S
misconduct in research supported by Public Health Service (PHS) support, Donald Wright,
National Institute of Allergy and Respondent agreed to have her research Acting Director, Office of Research Integrity.
Infectious Diseases (NIAID), National supervised for a period of three (3) years [FR Doc. 2015–18088 Filed 7–22–15; 8:45 am]
Institutes of Health (NIH), grants R01 beginning on the date of her BILLING CODE 4150–28–P
AI078788, R21 AI093255, and R37 employment in a position in which she
AI064003. receives or applies for PHS support and
ORI found that Respondent engaged to notify her employer(s)/institution(s) DEPARTMENT OF HEALTH AND
in research misconduct by falsifying of the terms of this supervision; HUMAN SERVICES
and/or fabricating data that were Respondent agreed that prior to the
included in one (1) publication, two (2) submission of an application for PHS National Institutes of Health
unfunded grant applications, and one support for a research project on which Center for Scientific Review; Notice of
(1) unpublished manuscript: her participation is proposed and prior Closed Meeting
Journal of Virology 87:3549–3560, to her participation in any capacity on
2013 (hereafter referred to as ‘‘JVI PHS-supported research, Respondent Pursuant to section 10(d) of the
2013’’). shall ensure that a plan for supervision Federal Advisory Committee Act, as
• R01 AI114367–01A1 of her duties is submitted to ORI for amended (5 U.S.C. App.), notice is
• R01 AI120787–01 approval; the supervision plan must be hereby given of the following meeting.
• ‘‘A single amino acid in the CD4 designed to ensure the scientific The meeting will be closed to the
binding site of HIV–1 Env is a key
mstockstill on DSK4VPTVN1PROD with NOTICES
integrity of her research contribution; public in accordance with the
determinant of species tropism.’’ Respondent agreed that she shall not provisions set forth in sections
Unpublished manuscript participate in any PHS-supported 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Specifically, ORI found that: research until such a supervision plan is as amended. The grant applications and
1. Respondent falsified and/or submitted to and approved by ORI; the discussions could disclose
fabricated in vitro rates of viral Respondent agreed to maintain confidential trade secrets or commercial
replication or infection in human and responsibility for compliance with the property such as patentable material,
macaque lymphocytes and infectious agreed upon supervision plan; and personal information concerning
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Document Created: 2015-12-15 12:53:21
Document Modified: 2015-12-15 12:53:21
| 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 August 24, 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 43782 |
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