83 FR 42509 - Agency Information Collection Activities; Proposed Collection; Comment Request; Sun Protection Factor Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 163 (August 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 163 (August 22, 2018)
| Page Range | 42509-42512 | |
| FR Document | 2018-18073 |
[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)] [Notices] [Pages 42509-42512] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18073] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0449] Agency Information Collection Activities; Proposed Collection; Comment Request; Sun Protection Factor Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on sun protection factor (SPF) labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and comments on compliance with Drug Facts labeling requirements for all OTC sunscreen products. DATES: Submit either electronic or written comments on the collection of information by October 22, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 22, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2011-N-0449 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The [[Page 42510]] second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [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, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's 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. SPF Labeling and Testing Requirements for OTC Sunscreen Products--21 CFR 201.327(a)(1) and (i), 21 CFR 201.66(c) and (d) OMB Control Number 0910-0717--Extension I. Background 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, the 2011 sunscreen final rule lifted the delay of implementing the prior 1999 sunscreen final rule (published in the Federal Register of May 21, 1999 (64 FR 27666) and stayed in the Federal Register of December 31, 2001 (66 FR 67485) from complying with the 1999 Drug Facts labeling final rule (published in the Federal Register of 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 Drug Facts labeling final rule added new Sec. 201.66 to part 201. Section 201.66 establishes content and format requirements for the Drug Facts portion of OTC drug product labels. We specifically exempted OTC sunscreen products from complying with the 1999 Drug Facts 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 in the Federal Register of May 11, 2012 (77 FR 27591) (2012 extension date notice). II. 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 regarding SPF labeling and testing requirements for OTC sunscreen products containing specified ingredients and marketed without approved applications (2011 60-day notice). 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 sunscreen final rule to include the SPF value determined by conducting the SPF test outlined in Sec. 201.327(i). Therefore, that provision resulted in an information collection with a third-party disclosure burden for manufacturers of OTC sunscreens covered by the 2011 sunscreen rule. We determined that products need only complete the testing and labeling required by the 2011 sunscreen rule once and then continue to use 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 sunscreen final rule for all OTC sunscreens covered by that rule. We determined that the third-party disclosure burden by manufacturers of OTC sunscreens covered by the 2011 sunscreen rule was based on: (1) An estimate 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) the conduct of SPF testing based on the estimated number of existing formulations; (3) an estimate of the time to relabel currently marketed OTC sunscreens containing specified ingredients and marketed without approved applications; and (4) testing and labeling of new products introduced each year. The estimate for this burden in the 2011 60-day notice was a total of 30,066 hours in years 1 and 2, and a total of 966 in each subsequent year. All currently marketed OTC sunscreen drug products are already required to comply with the SPF labeling requirements specified by the 2011 sunscreen final rule. However, our original estimate also included the burden of new products introduced each year. We estimated that as many as [[Page 42511]] 60 new OTC sunscreen products stock keeping units (SKUs) may be introduced each year, which must 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 received only two comments on our estimated information collection burden (FDA-2011-N-0449-0002 and FDA-2011-N-0449-0003). These comments were already addressed in FDA's notice entitled ``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'' published in the Federal Register of 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. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of disclosures Total annual Activity respondents per disclosures Average burden per disclosure Total hours respondent -------------------------------------------------------------------------------------------------------------------------------------------------------- Conduct SPF testing in accordance with 20 1.95 39 24.......................................... 936 Sec. 201.327(i) for new sunscreens. Create PDP labeling in accordance with 20 3 60 0.5 (30 minutes)............................ 30 Sec. 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. III. Drug Facts Labeling for OTC Sunscreens Because the 2011 sunscreen final rule also lifted the delay of implementing the Drug Facts regulations (Sec. 201.66) for OTC sunscreens, the rule also modified the information collection associated with Sec. 201.66 (currently approved under OMB control number 0910-0340) and added a third-party disclosure burden resulting from requiring OTC sunscreen products to comply with Drug Facts regulations. In the 1999 Drug Facts 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 OTC drug products, codified in Sec. 201.66. This section establishes 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, OTC sunscreen products already on the market at that time incurred a one-time burden to comply with the requirements in Sec. 201.66(c) and (d). In the 60- day notice, the burden was estimated as 43,200 hours for existing sunscreen SKUs and 720 hours for new sunscreen SKUs. The compliance dates for the 2011 sunscreen final rule that lifted 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 the 2012 extension date notice. All currently marketed sunscreen products are, therefore, already required to comply with the Drug Facts labeling requirements in Sec. 201.66 and will incur no further burden in the 1999 Drug Facts 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 notice, we estimated that as many as 60 new product SKUs marketed each year must comply with Drug Facts regulations. We estimated that these 60 SKUs would be marketed by 30 manufacturers, which will spend approximately 12 hours on each label based on the most recent estimate used for other OTC drug products to comply with the 1999 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, 12 hours per 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 considered this 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 Drug Facts labeling 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. FDA estimates the burden of this collection of information as follows: [[Page 42512]] Table 2--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Number of disclosures Total annual Average Activity respondents per disclosures burden per Total hours respondent disclosure ---------------------------------------------------------------------------------------------------------------- Format labeling in accordance 20 3 60 12 720 with Sec. 201.66(c) and (d) for new sunscreen SKUs......... Request for Drug Facts exemption 1 0.125 0.125 24 3 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. We note that these estimates may be adjusted in the future development of an upcoming rulemaking on over-the-counter sunscreen products (RIN 0910-AA01). FDA intends to amend this information collection and/or seek approval of additional information collections, as appropriate, concurrent with this rulemaking. Dated: August 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-18073 Filed 8-21-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42509
Center’s website following the meeting: DEPARTMENT OF HEALTH AND the docket unchanged. Because your
https://healthpolicy.duke.edu/events/ HUMAN SERVICES comment will be made public, you are
expanding-access-to-treatment-for-OUD. solely responsible for ensuring that your
Webcast participants will be able to Food and Drug Administration comment does not include any
submit questions and comments via the [Docket No. FDA–2011–N–0449]
confidential information that you or a
webcast portal. Persons interested in third party may not wish to be posted,
participating in the live webcast must Agency Information Collection such as medical information, your or
register online by September 19, 2018, Activities; Proposed Collection; anyone else’s Social Security number, or
by 5 p.m. Eastern Time (see Registration Comment Request; Sun Protection confidential business information, such
section above). Early registration is Factor Labeling and Testing as a manufacturing process. Please note
recommended because webcast Requirements for Over-the-Counter that if you include your name, contact
connections are limited. Organizations Sunscreen Drug Products information, or other information that
are required to register all participants; identifies you in the body of your
however, we request that organizations AGENCY: Food and Drug Administration, comments, that information will be
view the meeting using one connection HHS. posted on https://www.regulations.gov.
per location whenever possible. ACTION: Notice. • If you want to submit a comment
with confidential information that you
Other Issues for Consideration: All SUMMARY: The Food and Drug do not wish to be made available to the
event materials will be provided to Administration (FDA or Agency) is public, submit the comment as a
registered attendees via email prior to announcing an opportunity for public written/paper submission and in the
the meeting and will be made publicly comment on the proposed collection of manner detailed (see ‘‘Written/Paper
available at the Duke-Margolis Center’s certain information by the Agency. Submissions’’ and ‘‘Instructions’’).
website: https://healthpolicy.duke.edu/ Under the Paperwork Reduction Act of
events/expanding-access-to-treatment- Written/Paper Submissions
1995 (PRA), Federal Agencies are
for-OUD. A 1-hour lunch break is required to publish notice in the Submit written/paper submissions as
scheduled, but food will not be Federal Register concerning each follows:
provided. There are multiple restaurants proposed collection of information, • Mail/Hand delivery/Courier (for
within walking distance of the including each proposed extension of an written/paper submissions): Dockets
Conference Center. existing collection of information, and Management Staff (HFA–305), Food and
IV. References to allow 60 days for public comment in Drug Administration, 5630 Fishers
response to the notice. This notice Lane, Rm. 1061, Rockville, MD 20852.
The following references are on solicits comments on sun protection • For written/paper comments
display in the Dockets Management factor (SPF) labeling and testing submitted to the Dockets Management
Staff (HFA–305), Food and Drug requirements for over-the-counter (OTC) Staff, FDA will post your comment, as
Administration, 5630 Fishers Lane, Rm. sunscreen products containing specified well as any attachments, except for
1061, Rockville, MD 20852, and are ingredients and marketed without information submitted, marked and
available for viewing by interested approved applications, and comments identified, as confidential, if submitted
persons between 9 a.m. and 4 p.m., on compliance with Drug Facts labeling as detailed in ‘‘Instructions.’’
Monday through Friday; they are also requirements for all OTC sunscreen Instructions: All submissions received
available electronically at https:// products. must include the Docket No. FDA–
www.regulations.gov. FDA has verified 2011–N–0449 for ‘‘Agency Information
DATES: Submit either electronic or Collection Activities; Proposed
the website addresses, as of the date this
written comments on the collection of Collection; Comment Request; Sun
document publishes in the Federal
information by October 22, 2018. Protection Factor Labeling and Testing
Register, but websites are subject to
change over time. ADDRESSES: You may submit comments Requirements and Drug Facts Labeling
as follows. Please note that late, for Over-the-Counter Sunscreen Drug
1. Hedegaard, H., M. Warner, and A.M. untimely filed comments will not be Products.’’ Received comments, those
Miniño, ‘‘Drug Overdose Deaths in the filed in a timely manner (see
considered. Electronic comments must
United States, 1999–2016,’’ NCHS Data
be submitted on or before October 22, ADDRESSES), will be placed in the docket
Brief, no. 294, Hyattsville, MD: National
Center for Health Statistics. 2017
2018. The https://www.regulations.gov and, except for those submitted as
(available at https://www.cdc.gov/nchs/ electronic filing system will accept ‘‘Confidential Submissions,’’ publicly
products/databriefs/db294.htm), comments until midnight Eastern Time viewable at https://www.regulations.gov
accessed June 27, 2018. at the end of October 22, 2018. or at the Dockets Management Staff
2. Substance Abuse and Mental Health Comments received by mail/hand between 9 a.m. and 4 p.m., Monday
Services Administration, Center for delivery/courier (for written/paper through Friday.
Behavioral Health Statistics and Quality, submissions) will be considered timely • Confidential Submissions—To
‘‘Results from the 2016 National Survey if they are postmarked or the delivery submit a comment with confidential
on Drug Use and Health: Detailed service acceptance receipt is on or information that you do not wish to be
Tables.’’ September 8, 2016 (available at before that date. made publicly available, submit your
https://www.samhsa.gov/data/sites/ comments only as a written/paper
default/files/NSDUH-DetTabs-2016/ Electronic Submissions submission. You should submit two
NSDUH-DetTabs-2016.htm), accessed Submit electronic comments in the copies total. One copy will include the
amozie on DSK3GDR082PROD with NOTICES1
June 27, 2018. following way: information you claim to be confidential
• Federal eRulemaking Portal: with a heading or cover note that states
Dated: August 16, 2018.
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
Leslie Kux, instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Associate Commissioner for Policy. Comments submitted electronically, Agency will review this copy, including
[FR Doc. 2018–18071 Filed 8–21–18; 8:45 am] including attachments, to https:// the claimed confidential information, in
BILLING CODE 4164–01–P www.regulations.gov will be posted to its consideration of comments. The
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![42512 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number disclosures Total annual
Activity burden per Total hours
of respondents per disclosures disclosure
respondent
Format labeling in accordance with § 201.66(c) and (d) for
new sunscreen SKUs ....................................................... 20 3 60 12 720
Request for Drug Facts exemption or deferral § 201.66(e) 1 0.125 0.125 24 3
Total .............................................................................. ........................ ........................ ........................ ........................ 723
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We note that these estimates may be Competition and Patent Term urgency, and frequency, and for the
adjusted in the future development of Restoration Act of 1984 (Pub. L. 98–417) treatment of pediatric patients aged 6
an upcoming rulemaking on over-the- (the 1984 amendments), which years and older with symptoms of
counter sunscreen products (RIN 0910– authorized the approval of duplicate detrusor overactivity associated with a
AA01). FDA intends to amend this versions of drug products under an neurological condition (e.g., spina
information collection and/or seek ANDA procedure. ANDA applicants bifida).
approval of additional information must, with certain exceptions, show that In a letter dated December 14, 2017,
collections, as appropriate, concurrent the drug for which they are seeking Janssen Pharmaceuticals Inc. notified
with this rulemaking. approval contains the same active FDA that DITROPAN XL (oxybutynin
ingredient in the same strength and chloride) Extended Release Tablets, 15
Dated: August 16, 2018.
dosage form as the ‘‘listed drug,’’ which mg, were being discontinued, and FDA
Leslie Kux,
is a version of the drug that was moved the drug product to the
Associate Commissioner for Policy. previously approved. ANDA applicants ‘‘Discontinued Drug Product List’’
[FR Doc. 2018–18073 Filed 8–21–18; 8:45 am] do not have to repeat the extensive section of the Orange Book. Although
BILLING CODE 4164–01–P clinical testing otherwise necessary to DITROPAN XL (oxybutynin chloride)
gain approval of a new drug application Extended Release Tablets, 5 mg and 10
(NDA). mg, were also previously listed in the
DEPARTMENT OF HEALTH AND The 1984 amendments include what ‘‘Discontinued Drug Product List’’
HUMAN SERVICES is now section 505(j)(7) of the Federal section of the Orange Book, they are
Food, Drug, and Cosmetic Act (21 U.S.C. now listed in the ‘‘Prescription Drug
Food and Drug Administration 355(j)(7)), which requires FDA to Product List’’ section of the Orange
[Docket Nos. FDA–2018–P–1335 and FDA– publish a list of all approved drugs. Book.
2018–P–1361] FDA publishes this list as part of the Hyman, Phelps & McNamara, P.C.,
‘‘Approved Drug Products With submitted a citizen petition dated
Determination That DITROPAN XL Therapeutic Equivalence Evaluations,’’ March 30, 2018 (Docket No. FDA–2018–
(Oxybutynin Chloride) Extended which is known generally as the P–1335), and Ajanta Pharma Limited
Release Tablets, 15 Milligrams, Were ‘‘Orange Book.’’ Under FDA regulations, submitted a citizen petition dated April
Not Withdrawn From Sale for Reasons drugs are removed from the list if the 2, 2018 (Docket No. FDA–2018–P–
of Safety or Effectiveness Agency withdraws or suspends 1361), under 21 CFR 10.30, requesting
approval of the drug’s NDA or ANDA that the Agency determine whether
AGENCY: Food and Drug Administration,
for reasons of safety or effectiveness or DITROPAN XL (oxybutynin chloride)
HHS.
if FDA determines that the listed drug Extended Release Tablets, 5 mg, 10 mg,
ACTION: Notice. was withdrawn from sale for reasons of and 15 mg, were withdrawn from sale
SUMMARY: The Food and Drug safety or effectiveness (21 CFR 314.162). for reasons of safety or effectiveness.
A person may petition the Agency to As noted, DITROPAN XL (oxybutynin
Administration (FDA or Agency) has
determine, or the Agency may chloride) Extended Release Tablets, 5
determined that DITROPAN XL
determine on its own initiative, whether mg and 10 mg, are no longer listed in
(oxybutynin chloride) Extended Release
a listed drug was withdrawn from sale the ‘‘Discontinued Drug Product List’’
Tablets, 15 milligrams (mg), were not
for reasons of safety or effectiveness. section of the Orange Book, and
withdrawn from sale for reasons of
This determination may be made at any therefore we need not determine
safety or effectiveness. This
time after the drug has been withdrawn whether they were withdrawn from sale
determination will allow FDA to
from sale, but must be made prior to for reasons of safety or effectiveness.
approve abbreviated new drug With regard to DITROPAN XL
approving an ANDA that refers to the
applications (ANDAs) for DITROPAN (oxybutynin chloride) Extended Release
listed drug (§ 314.161 (21 CFR 314.161)).
XL (oxybutynin chloride) Extended Tablets, 15 mg, after considering the
FDA may not approve an ANDA that
Release Tablets, 15 mg, if all other legal citizen petition and reviewing Agency
does not refer to a listed drug.
and regulatory requirements are met. DITROPAN XL (oxybutynin chloride) records, and based on the information
FOR FURTHER INFORMATION CONTACT: Glen Extended Release Tablets, 5 mg, 10 mg, we have at this time, FDA has
amozie on DSK3GDR082PROD with NOTICES1
Cheng, Center for Drug Evaluation and and 15 mg, are the subject of NDA determined under § 314.161 that
Research, Food and Drug 020897, held by Janssen DITROPAN XL (oxybutynin chloride)
Administration, 10903 New Hampshire Pharmaceuticals Inc., and initially Extended Release Tablets, 15 mg, were
Ave., Bldg. 51, Rm. 6210, Silver Spring, approved on December 16, 1998. not withdrawn from sale for reasons of
MD 20993–0002, 301–796–1494. DITROPAN XL is indicated for the safety or effectiveness. The petitioners
SUPPLEMENTARY INFORMATION: In 1984, treatment of overactive bladder with have identified no data or other
Congress enacted the Drug Price symptoms of urge urinary incontinence, information suggesting that this drug
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Document Created: 2018-08-22 00:39:22
Document Modified: 2018-08-22 00:39:22
| 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 October 22, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 42509 |
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