83 FR 61388 - Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 230 (November 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 230 (November 29, 2018)
| Page Range | 61388-61390 | |
| FR Document | 2018-25950 |
[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)] [Notices] [Pages 61388-61390] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25950] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA [[Page 61389]] announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance. DATES: Submit either electronic or written comments on the draft guidance by January 28, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: 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-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised Draft Guidances for Industry.'' Received comments 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 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidances to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance documents. FOR FURTHER INFORMATION CONTACT: Wendy Good, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 240-402-1146. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the Federal Register on October 10, 2018. This notice announces draft product-specific guidances, either new or revised, that are posted on FDA's website. II. Drug Products for Which New Draft Product-Specific Guidances Are Available FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients: [[Page 61390]] Table 1--New Draft Product-Specific Guidances for Drug Products ------------------------------------------------------------------------ ------------------------------------------------------------------------- Amphetamine. Atropine sulfate; Diphenoxylate hydrochloride. Dichlorphenamide. Doxepin hydrochloride. Ertugliflozin. Ertugliflozin; Metformin hydrochloride. Ertugliflozin; sitagliptin phosphate. Estradiol. Latanoprostene bunod. Letermovir (multiple Reference Listed Drugs). Levothyroxine sodium. Lifitegrast. Macimorelin acetate. Metoprolol succinate. Netarsudil dimesylate. Nitazoxanide. Penicillamine. Plecanatide. Reserpine. Ribociclib succinate. Thiothixene. ------------------------------------------------------------------------ III. Drug Products for Which Revised Draft Product-Specific Guidances Are Available FDA is announcing the availability of revised draft product- specific guidances for industry for drug products containing the following active ingredients: Table 2--Revised Draft Product-Specific Guidances for Drug Products ------------------------------------------------------------------------ ------------------------------------------------------------------------- Acetaminophen; Butalbital; Caffeine (multiple Reference Listed Drugs). Acetaminophen; Oxycodone HCl. Adapalene (multiple Reference Listed Drugs). Adapalene; Benzoyl peroxide (multiple Reference Listed Drugs). Asenapine maleate. Benzoyl peroxide; Clindamycin phosphate (multiple Reference Listed Drugs). Benzoyl peroxide; Erythromycin (multiple Reference Listed Drugs). Clindamycin phosphate (multiple Reference Listed Drugs). Clindamycin phosphate; Tretinoin. Dapsone (multiple Reference Listed Drugs). Everolimus. Isosorbide dinitrate. Metaxalone. Mycophenolic acid. Nitazoxanide. Sulfacetamide Sodium. Sulfamethoxazole; Trimethoprim. Sumatriptan. Tazarotene (multiple Reference Listed Drugs). Tretinoin (multiple Reference Listed Drugs and multiple .strengths). Triamterene. Zolmitriptan. ------------------------------------------------------------------------ For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369. These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. IV. Electronic Access Persons with access to the internet may obtain the draft guidances at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: November 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-25950 Filed 11-28-18; 8:45 am] BILLING CODE 4164-01-P
![61388 Federal Register / Vol. 83, No. 230 / Thursday, November 29, 2018 / Notices
from the internet. See the For a 510(k), such studies are often and CLIA Waiver by Application
SUPPLEMENTARY INFORMATION section for performed by trained operators (i.e., test Studies.’’ It does not establish any rights
information on electronic access to the operators who meet the qualifications to for any person and is not binding on
guidance. Submit written requests for a perform moderate complexity testing FDA or the public. You can use an
single hard copy of the draft guidance and with previous training in alternative approach if it satisfies the
document entitled ‘‘Recommendations performing the test; sometimes referred requirements of the applicable statutes
for Dual 510(k) and CLIA Waiver by to as ‘‘moderate complexity users’’). For and regulations. This guidance is not
Application Studies’’ to the Office of the a CLIA Waiver by Application, we subject to Executive Order 12866.
Center Director, Guidance and Policy believe such studies need to be
conducted by the intended user (i.e., test III. Electronic Access
Development, Center for Devices and
Radiological Health, Food and Drug operators in waived settings and with Persons interested in obtaining a copy
Administration, 10903 New Hampshire limited or no training or hands-on of the draft guidance may do so by
Ave., Bldg. 66, Rm. 5431, Silver Spring, experience in conducting laboratory downloading an electronic copy from
MD 20993–0002. Send one self- testing; sometimes referred to as the internet. A search capability for all
addressed adhesive label to assist that ‘‘untrained operators’’ or ‘‘waived Center for Devices and Radiological
office in processing your request. users’’) (see 42 U.S.C. 263a(d)(3)). Health guidance documents is available
An applicant may choose to conduct at https://www.fda.gov/MedicalDevices/
FOR FURTHER INFORMATION CONTACT:
a single set of comparison and DeviceRegulationandGuidance/
Peter Tobin, Center for Devices and
reproducibility studies with untrained GuidanceDocuments/default.htm. This
Radiological Health, Food and Drug
operators to satisfy certain requirements guidance document is also available at
Administration, 10903 New Hampshire
to establish both substantial equivalence https://www.regulations.gov. Persons
Ave., Bldg. 66, Rm. 5657, Silver Spring,
under section 513(i) of the FD&C Act (21
MD 20993–0002, 240–402–6169. unable to download an electronic copy
U.S.C. 360c(i) for 510(k) clearance and
SUPPLEMENTARY INFORMATION: of ‘‘Recommendations for Dual 510(k)
simplicity and insignificant risk of
and CLIA Waiver by Application
I. Background erroneous results under 42 U.S.C.
Studies’’ may send an email request to
263a(d)(3) for CLIA waiver. To
Typically, in an application for CLIA CDRH-Guidance@fda.hhs.gov to receive
streamline the review of such data, the
waiver (CLIA Waiver by Application) a an electronic copy of the document.
Dual 510(k) and CLIA Waiver by
manufacturer submits evidence to FDA Please use the document number 16038
Application (Dual Submission) pathway
that a previously cleared or approved to identify the guidance you are
was established as part of the Medical
test, initially categorized as moderate requesting.
Device User Fee Amendments of 2012
complexity, meets the CLIA statutory (MDUFA III), allowing the review of IV. Paperwork Reduction Act of 1995
criteria for waiver, 42 U.S.C. 263a(d)(3), both a 510(k) and CLIA Waiver by
and requests that FDA categorize the Application within a single submission This draft guidance refers to
test as waived. This means that with a reduced overall review time previously approved collections of
historically a CLIA Waiver by compared to sequential submissions. information. These collections of
Application has followed clearance or information are subject to review by the
approval of an IVD test. II. Significance of Guidance Office of Management and Budget
While a premarket notification This draft guidance is being issued (OMB) under the Paperwork Reduction
(510(k)) and CLIA Waiver by consistent with FDA’s good guidance Act of 1995 (44 U.S.C. 3501–3520). The
Application each include discrete practices regulation (21 CFR 10.115). collections of information in the
elements not required in the other, both The draft guidance, when finalized, will following FDA regulations and guidance
submissions generally include represent the current thinking of FDA have been approved by OMB as listed in
comparison and reproducibility studies. on ‘‘Recommendations for Dual 510(k) the following table:
21 CFR part; guidance; or FDA form Topic OMB Control No.
807, subpart E ......................................................................... Premarket notification .............................................................. 0910–0120
‘‘Recommendations for Clinical Laboratory Improvement CLIA Waiver Applications ........................................................ 0910–0598
Amendments of 1988 (CLIA) Waiver Applications for Man-
ufacturers of In Vitro Diagnostic Devices’’.
‘‘Administrative Procedures for CLIA Categorization’’ ............. CLIA Categorizations .............................................................. 0910–0607
‘‘Requests for Feedback on Medical Device Submissions: Q-Submissions ........................................................................ 0910–0756
The Pre-Submission Program and Meetings with Food and
Drug Administration Staff’’.
Dated: November 26, 2018. DEPARTMENT OF HEALTH AND ACTION: Notice of availability.
Leslie Kux, HUMAN SERVICES
SUMMARY: The Food and Drug
Associate Commissioner for Policy. Administration (FDA or Agency) is
Food and Drug Administration
[FR Doc. 2018–25960 Filed 11–28–18; 8:45 am] announcing the availability of
additional draft and revised draft
khammond on DSK30JT082PROD with NOTICES
BILLING CODE 4164–01–P
[Docket No. FDA–2007–D–0369]
product-specific guidances. The
Product-Specific Guidances; Draft and guidances provide product-specific
Revised Draft Guidances for Industry; recommendations on, among other
Availability things, the design of bioequivalence
(BE) studies to support abbreviated new
AGENCY: Food and Drug Administration, drug applications (ANDAs). In the
HHS. Federal Register of June 11, 2010, FDA
VerDate Sep<11>2014 16:42 Nov 28, 2018 Jkt 247001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/83_FR_61618/page/1.svg)
![61390 Federal Register / Vol. 83, No. 230 / Thursday, November 29, 2018 / Notices
TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS
Amphetamine.
Atropine sulfate; Diphenoxylate hydrochloride.
Dichlorphenamide.
Doxepin hydrochloride.
Ertugliflozin.
Ertugliflozin; Metformin hydrochloride.
Ertugliflozin; sitagliptin phosphate.
Estradiol.
Latanoprostene bunod.
Letermovir (multiple Reference Listed Drugs).
Levothyroxine sodium.
Lifitegrast.
Macimorelin acetate.
Metoprolol succinate.
Netarsudil dimesylate.
Nitazoxanide.
Penicillamine.
Plecanatide.
Reserpine.
Ribociclib succinate.
Thiothixene.
III. Drug Products for Which Revised for industry for drug products
Draft Product-Specific Guidances Are containing the following active
Available ingredients:
FDA is announcing the availability of
revised draft product-specific guidances
TABLE 2—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS
Acetaminophen; Butalbital; Caffeine (multiple Reference Listed Drugs).
Acetaminophen; Oxycodone HCl.
Adapalene (multiple Reference Listed Drugs).
Adapalene; Benzoyl peroxide (multiple Reference Listed Drugs).
Asenapine maleate.
Benzoyl peroxide; Clindamycin phosphate (multiple Reference Listed Drugs).
Benzoyl peroxide; Erythromycin (multiple Reference Listed Drugs).
Clindamycin phosphate (multiple Reference Listed Drugs).
Clindamycin phosphate; Tretinoin.
Dapsone (multiple Reference Listed Drugs).
Everolimus.
Isosorbide dinitrate.
Metaxalone.
Mycophenolic acid.
Nitazoxanide.
Sulfacetamide Sodium.
Sulfamethoxazole; Trimethoprim.
Sumatriptan.
Tazarotene (multiple Reference Listed Drugs).
Tretinoin (multiple Reference Listed Drugs and multiple .strengths).
Triamterene.
Zolmitriptan.
For a complete history of previously studies to support ANDAs. They do not http://www.fda.gov/Drugs/
published Federal Register notices establish any rights for any person and GuidanceComplianceRegulatory
related to product-specific guidances, go are not binding on FDA or the public. Information/Guidances/default.htm or
to https://www.regulations.gov and You can use an alternative approach if https://www.regulations.gov.
enter Docket No. FDA–2007–D–0369. it satisfies the requirements of the
khammond on DSK30JT082PROD with NOTICES
Dated: November 23, 2018.
These draft guidances are being applicable statutes and regulations. This
guidance is not subject to Executive Leslie Kux,
issued consistent with FDA’s good
Order 12866. Associate Commissioner for Policy.
guidance practices regulation (21 CFR
[FR Doc. 2018–25950 Filed 11–28–18; 8:45 am]
10.115). These draft guidances, when IV. Electronic Access
finalized, will represent the current BILLING CODE 4164–01–P
thinking of FDA on, among other things, Persons with access to the internet
the product-specific design of BE may obtain the draft guidances at either
VerDate Sep<11>2014 16:42 Nov 28, 2018 Jkt 247001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/83_FR_61618/page/3.svg)
Document Created: 2018-11-28 23:44:32
Document Modified: 2018-11-28 23:44:32
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by January 28, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Wendy Good, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 240-402-1146. | |
| FR Citation | 83 FR 61388 |
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