83 FR 46745 - 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 179 (September 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 179 (September 14, 2018)
| Page Range | 46745-46747 | |
| FR Document | 2018-20018 |
[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)] [Notices] [Pages 46745-46747] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20018] ----------------------------------------------------------------------- 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 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 DATES: Submit either electronic or written comments on the draft guidance by November 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 [[Page 46746]] 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, 240-402-9682. 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 July 20, 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 a new draft product-specific guidances for industry for drug products containing the following active ingredients: Table 1--New Draft Product-Specific Guidances for Drug Products ------------------------------------------------------------------------ ------------------------------------------------------------------------- Abemaciclib Albuterol sulfate Allopurinol; Lesinurad Amantadine hydrochloride Amphetamine aspartate; Amphetamine sulfate; Dextroamphetamine saccharate; Dextroamphetamine sulfate Azelaic acid Benznidazole Brigatinib Brimonidine tartrate; Timolol maleate Chlorzoxazone Ciprofloxacin hydrochloride Dapagliflozin propanediol; Saxagliptin hydrochloride Delafloxacin meglumine Desonide Deutetrabenazine Diazepam Efinaconazole Enasidenib mesylate Glecaprevir; Pibrentasvir Ibuprofen; Pseudoephedrine hydrochloride Ivermectin Lamotrigine Luliconazole Midostaurin Miltefosine Morphine sulfate Neratinib maleate Olaparib Olive oil; Soybean oil Oxycodone hydrochloride Penciclovir Perflutren Pilocarpine hydrochloride Pitavastatin magnesium Pitavastatin sodium Pregabalin Secnidazole Sofosbuvir; Velpatasvir; Voxilaprevir Spironolactone Sulfur hexafluoride lipid-type a microspheres Talc Tavaborole ------------------------------------------------------------------------ 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 ------------------------------------------------------------------------ ------------------------------------------------------------------------- Acetazolamide Chlorpromazine hydrochloride Doxorubicin hydrochloride Morphine sulfate Nicotine polacrilex (multiple Reference Listed Drugs) Nisoldipine Oxycodone Raltegravir potassium Tacrolimus (multiple strengths) ------------------------------------------------------------------------ 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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. [[Page 46747]] Dated: September 10, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20018 Filed 9-13-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 46745
recommends that 3P Review complaints were resolved, or attempted experience with the program and the
Organizations establish a recordkeeping to be resolved. Therefore, we have recommendations in the guidance, we
system for tracking the submission of added an IC for ‘‘Recordkeeping system estimate the average burden per
those complaints and how those regarding complaints.’’ Based on our recordkeeping to be 2 hours.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
510(k) reviews 3 ................................................................... 7 21 147 10 1,470
Records regarding qualifications to receive FDA recogni-
tion as a 3P Review Organization 4 ................................. 7 1 7 1 7
Recordkeeping system regarding complaints 4 ................... 7 1 7 2 14
Total .............................................................................. ........................ ........................ ........................ ........................ 1,491
1 There are no capital costs or operating and maintenance costs associated with this IC.
We revised our estimates for OMB SUMMARY: The Food and Drug that if you include your name, contact
control number 0910–0375 by adding Administration (FDA or Agency) is information, or other information that
new ICs, changing the title of the ICR, announcing the availability of identifies you in the body of your
and adjusting the existing ICs based on additional draft and revised draft comments, that information will be
current trends. Despite the addition of product-specific guidances. The posted on https://www.regulations.gov.
new ICs, the estimated burden reflects guidances provide product-specific • If you want to submit a comment
an overall decrease of 5,581 hours. We recommendations on, among other with confidential information that you
attribute this adjustment to a decrease in things, the design of bioequivalence do not wish to be made available to the
the number of submissions we received (BE) studies to support abbreviated new public, submit the comment as a
over the last few years. drug applications (ANDAs). In the written/paper submission and in the
The draft guidance also refers to Federal Register of June 11, 2010, FDA manner detailed (see ‘‘Written/Paper
previously approved ICs found in FDA announced the availability of a guidance Submissions’’ and ‘‘Instructions’’).
regulations. The ICs in 21 CFR part 807, for industry entitled ‘‘Bioequivalence Written/Paper Submissions
subpart E have been approved under Recommendations for Specific
OMB control number 0910–0120; the Products’’ that explained the process Submit written/paper submissions as
ICs regarding 3P Review of medical that would be used to make product- follows:
devices under FDAMA have been specific guidances available to the • Mail/Hand delivery/Courier (for
approved under OMB control number public on FDA’s website. The guidances written/paper submissions): Dockets
0910–0375; the ICs for the device identified in this notice were developed Management Staff (HFA–305), Food and
appeals processes have been approved using the process described in that Drug Administration, 5630 Fishers
under OMB control number 0910–0738; guidance. Lane, Rm. 1061, Rockville, MD 20852.
the ICs in the guidance document • For written/paper comments
DATES: Submit either electronic or submitted to the Dockets Management
‘‘Requests for Feedback on Medical written comments on the draft guidance
Device Submissions: The Pre- Staff, FDA will post your comment, as
by November 13, 2018 to ensure that the well as any attachments, except for
Submission Program and Meetings with Agency considers your comment on this
Food and Drug Administration Staff’’ information submitted, marked and
draft guidance before it begins work on identified, as confidential, if submitted
have been approved under OMB control the final version of the guidance.
number 0910–0756. as detailed in ‘‘Instructions.’’
ADDRESSES: You may submit comments Instructions: All submissions received
Dated: September 10, 2018. on any guidance at any time as follows: must include the Docket No. FDA–
Leslie Kux, 2007–D–0369 for ‘‘Product-Specific
Associate Commissioner for Policy. Electronic Submissions
Guidances; Draft and Revised Draft
[FR Doc. 2018–19992 Filed 9–13–18; 8:45 am] Submit electronic comments in the Guidances for Industry.’’ Received
BILLING CODE 4164–01–P following way: comments will be placed in the docket
• Federal eRulemaking Portal: and, except for those submitted as
https://www.regulations.gov. Follow the ‘‘Confidential Submissions,’’ publicly
DEPARTMENT OF HEALTH AND instructions for submitting comments. viewable at https://www.regulations.gov
HUMAN SERVICES Comments submitted electronically, or at the Dockets Management Staff
including attachments, to https:// between 9 a.m. and 4 p.m., Monday
Food and Drug Administration www.regulations.gov will be posted to through Friday.
the docket unchanged. Because your • Confidential Submissions—To
[Docket No. FDA–2007–D–0369] comment will be made public, you are submit a comment with confidential
solely responsible for ensuring that your information that you do not wish to be
daltland on DSKBBV9HB2PROD with NOTICES
Product-Specific Guidances; Draft and comment does not include any made publicly available, submit your
Revised Draft Guidances for Industry; confidential information that you or a comments only as a written/paper
Availability third party may not wish to be posted, submission. You should submit two
AGENCY: Food and Drug Administration, such as medical information, your or copies total. One copy will include the
HHS. anyone else’s Social Security number, or information you claim to be confidential
confidential business information, such with a heading or cover note that states
ACTION: Notice of availability.
as a manufacturing process. Please note ‘‘THIS DOCUMENT CONTAINS
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![Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 46747
Dated: September 10, 2018. The topics to be discussed during the Prevention Division has issued a
Leslie Kux, teleconference include finalizing certificate of alternative compliance
Associate Commissioner for Policy. recommendations regarding innovative from the International Regulations for
[FR Doc. 2018–20018 Filed 9–13–18; 8:45 am] systems of care, barriers to effective data Preventing Collisions at Sea, 1972 (72
BILLING CODE 4164–01–P
collection, and primary prevention COLREGS), for the TUG JUDY MORAN,
related serious mental illness; Hull 123. We are issuing this notice
discussing the framework and speakers because its publication is required by
DEPARTMENT OF HEALTH AND for the following disparities-themed statute. Due to the construction and
HUMAN SERVICES report that will include placement of the vessel’s side lights and
recommendations; and discussing the stern lights, TUG JUDY MORAN cannot
Meeting of the Advisory Committee on agenda for the next meeting. The fully comply with the light, shape, or
Minority Health recommendations will be given to the sound signal provisions of the 72
Deputy Assistant Secretary for Minority COLREGS without interfering with the
AGENCY: Office of Minority Health,
Health. vessel’s design and construction. This
Office of the Secretary, Department of
This call will be limited to 125 notification of issuance of a certificate of
Health and Human Services.
participants. The OMH will make every alternative compliance promotes the
ACTION: Notice of meeting. effort to accommodate persons with Coast Guard’s marine safety mission.
SUMMARY: As stipulated by the Federal special needs. Individuals who have DATES: The Certificate of Alternative
Advisory Committee Act, the special needs for which special Compliance was issued on 26 July,
Department of Health and Human accommodations may be required 2018.
Services (HHS) is hereby giving notice should contact Professional and
Scientific Associates at (703) 234–1700 FOR FURTHER INFORMATION CONTACT: For
that the Advisory Committee on information or questions about this
Minority Health (ACMH) will hold a and reference this meeting. Requests for
special accommodations should be notice call or email Mr. Kevin Miller,
meeting conducted as a telephone First District Towing Vessel/Barge
conference call. This call will be open made at least ten (10) business days
prior to the meeting. Safety Specialist, U.S. Coast Guard;
to the public. Preregistration is required telephone (617) 223–8272, email
Members of the public will have an
for both public participation and Kevin.L.Miller2@uscg.mil.
opportunity to provide comments at the
comment. Any individual who wishes
meeting. Public comments will be SUPPLEMENTARY INFORMATION:
to participate in the call should email
limited to two minutes per speaker The United States is signatory to the
OMH-ACMH@hhs.gov by October 11,
during the time allotted. Individuals International Maritime Organization’s
2018. Instructions regarding
who would like to submit written International Regulations for Preventing
participating in the call and how to
statements should email, mail, or fax Collisions at Sea, 1972 (72 COLREGS),
provide verbal public comments will be
their comments to the designated as amended. The special construction or
given at the time of preregistration.
contact at least seven (7) business days purpose of some vessels makes them
Information about the meeting is
prior to the meeting. unable to comply with the light, shape,
available from the designated contact
Any members of the public who wish or sound signal provisions of the 72
and will be posted on the website for
to have electronic or printed material COLREGS. Under statutory law,
the Office of Minority Health (OMH),
distributed to ACMH members should however, specified 72 COLREGS
www.minorityhealth.hhs.gov.
email OMH-ACMH@hhs.gov or mail provisions are not applicable to a vessel
Information about ACMH activities can
their materials to the Designated Federal of special construction or purpose if the
be found on the OMH website under the
Officer, ACMH, Tower Building, 1101 Coast Guard determines that the vessel
heading About OMH.
Wootton Parkway, Suite 600, Rockville, cannot comply fully with those
DATES: The conference call will be held Maryland 20852, prior to close of
on October 16, 2018, 1 p.m. to 3 p.m. requirements without interfering with
business on October 11, 2018. the special function of the vessel.1
EST.
Dated: September 5, 2018. The owner, builder, operator, or agent
ADDRESSES: Instructions regarding
participating in the call will be given at Violet Woo, of a special construction or purpose
the time of preregistration. Designated Federal Officer, Advisory vessel may apply to the Coast Guard
Committee on Minority Health. District Office in which the vessel is
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–20040 Filed 9–13–18; 8:45 am] being built or operated for a
Violet Woo, Designated Federal Officer, determination that compliance with
BILLING CODE 4150–29–P
Advisory Committee on Minority alternative requirements is justified,2
Health, Office of Minority Health, and the Chief of the Prevention Division
Department of Health and Human would then issue the applicant a
Services, Tower Building, 1101 Wootton DEPARTMENT OF HOMELAND
SECURITY certificate of alternative compliance
Parkway, Suite 600, Rockville, (COAC) if he or she determines that the
Maryland 20852. Phone: 240–453–8222; vessel cannot comply fully with 72
Coast Guard
fax: 240–453–8223; email OMH-ACMH@ COLREGS light, shape, and sound signal
hhs.gov. [Docket No. USCG–2018–0801]
provisions without interference with the
SUPPLEMENTARY INFORMATION: In vessel’s special function.3 If the Coast
Certificate of Alternative Compliance
accordance with Public Law 105–392, Guard issues a COAC, it must publish
daltland on DSKBBV9HB2PROD with NOTICES
for the TUG JUDY MORAN Hull 123
the ACMH was established to provide notice of this action in the Federal
advice to the Deputy Assistant Secretary AGENCY: Coast Guard, DHS. Register.4
for Minority Health on improving the ACTION: Notification of issuance of a
health of each racial and ethnic certificate of alternative compliance. 1 33 U.S.C. 1605.
minority group and on the development 2 33 CFR 81.5.
of goals and specific program activities SUMMARY: The Coast Guard announces 3 33 CFR 81.9.
of the OMH. that the U. S. Coast Guard First District 4 33 U.S.C. 1605(c) and 33 CFR 81.18.
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Document Created: 2018-09-14 03:02:50
Document Modified: 2018-09-14 03:02:50
| 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 November 13, 2018 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, 240-402-9682. | |
| FR Citation | 83 FR 46745 |
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