82 FR 36792 - Product-Specific Guidances; Final Guidances for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 150 (August 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 150 (August 7, 2017)
| Page Range | 36792-36794 | |
| FR Document | 2017-16581 |
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)] [Notices] [Pages 36792-36794] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16581] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidances; Final 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 final 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 BE recommendations available to the public on FDA's Web site. The product- specific guidances identified in this notice were developed using the process described in that guidance. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments 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 [[Page 36793]] Guidances; Final 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. Submit written requests for single copies of a final guidance 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 a final guidance document. FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850. 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 Web site at http://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 Web site 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. Final product-specific guidances were last announced in the Federal Register on September 21, 2015 (80 FR 57000). This notice announces final product-specific guidances that are posted on FDA's Web site. II. Drug Products For Which Final Product-Specific Guidances Are Available FDA is announcing the availability of final product-specific guidances for industry for drug products containing the following active ingredients: Table 1--Final Product-Specific Guidances for Drug Products ------------------------------------------------------------------------ ------------------------------------------------------------------------- Acarbose. Acetaminophen; Aspirin, Caffeine. Acetaminophen; Butalbital; Caffeine; Codeine phosphate. Acitretin. Amoxicillin (multiple reference listed drugs). Amoxicillin; Clavulanate potassium. Aspirin; Butalbital; Caffeine (multiple reference listed drugs). Aspirin; Butalbital; Caffeine; Codeine Phosphate. Atenolol. Atenolol and Chlorthalidone. Cetirizine HCl. Chlorthalidone. Citalopram HBr. Citalopram hydrobromide. Clarithromycin. Clindamycin HCl. Clomiphene Citrate. Clonazepam. Clozapine. Cyclobenzaprine HCL. Cycloserine. Dapsone. Desipramine HCl. Desmopressin Acetate. Diflunisal. Diphenhydramine HCl. Dipyridamole. Disulfiram. Donepezil HCl. Doxazosin mesylate. Doxepin HCl. Doxercalciferol. Eprosartan Mesylate. Ethambutol HCl. Hydrochlorothiazide; Losartan Potassium. Hydrochlorothiazide; Triamterene. Hydrochlorothiazide; Valsartan. Hydrocodone bitartrate; Ibuprofen. Hydrocortisone. Hydromorphone HCl. Selegiline hydrochloride. Sotalol HCl. Tenofovir Disoproxil Fumarate. Tiagabine HCl. Valproic acid. Verapamil HCl. ------------------------------------------------------------------------ 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 final guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These guidances 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. III. Electronic Access Persons with access to the internet may obtain the final guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. [[Page 36794]] Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16581 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
![36792 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
regarding whether the applicant for including each proposed extension of an drug applications (ANDAs). In the
extension acted with due diligence existing collection of information, and Federal Register of June 11, 2010, FDA
during the regulatory review period. To to allow 60 days for public comment in announced the availability of a guidance
meet its burden, the petition must be response to the notice. for industry entitled ‘‘Bioequivalence
timely (see DATES) and contain sufficient In the March 15, 2017, Federal Recommendations for Specific
facts to merit an FDA investigation. (See Register notice, FDA proposed to extend Products’’ that explained the process
H. Rept. 857, part 1, 98th Cong., 2d the information collection related to that would be used to make product-
sess., pp. 41–42, 1984.) Petitions should SACs (OMB control number 0910– specific BE recommendations available
be in the format specified in 21 CFR 0766). However, we are withdrawing the to the public on FDA’s Web site. The
10.30. notice because, upon further review of product-specific guidances identified in
Submit petitions electronically to the information collection request (ICR) this notice were developed using the
http://www.regulations.gov at Docket associated with the notice and process described in that guidance.
No. FDA–2013–S–0610. Submit written comments received on the information DATES: Submit either electronic or
petitions (two copies are required) to the collection, we have determined that the written comments on Agency guidances
Dockets Management Staff (HFA–305), estimated burden expressed in the SAC at any time.
Food and Drug Administration, 5630 ICR is included as part of the estimated
burden for the information collections ADDRESSES: You may submit comments
Fishers Lane, Rm. 1061, Rockville, MD
in the premarket notification (510(k)) as follows:
20852.
ICR (OMB control number 0910–0120). Electronic Submissions
Dated: August 1, 2017.
Because the information collected for
Anna K. Abram, safety assurance cases is already Submit electronic comments in the
Deputy Commissioner for Policy, Planning, included under another information following way:
Legislation, and Analysis. collection approval, we have • Federal eRulemaking Portal:
[FR Doc. 2017–16516 Filed 8–4–17; 8:45 am] discontinued the ICR and we are https://www.regulations.gov. Follow the
BILLING CODE 4164–01–P withdrawing the March 15, 2017, notice instructions for submitting comments.
requesting comment on the information Comments submitted electronically,
collection. including attachments, to https://
DEPARTMENT OF HEALTH AND The guidance entitled ‘‘Infusion www.regulations.gov will be posted to
HUMAN SERVICES Pumps Total Product Life Cycle; the docket unchanged. Because your
Guidance for Industry and FDA Staff’’ comment will be made public, you are
Food and Drug Administration (https://www.fda.gov/ucm/groups/ solely responsible for ensuring that your
[Docket No. FDA–2017–N–0041] fdagov-public/@fdagov-meddev-gen/ comment does not include any
documents/document/ucm209337.pdf), confidential information that you or a
Agency Information Collection which provides recommendations on third party may not wish to be posted,
Activities; Proposed Collection; the inclusion of safety assurance cases such as medical information, your or
Comment Request; Safety Assurance as part of the premarket submissions for anyone else’s Social Security number, or
Case; Withdrawal of Notice new, changed, or modified infusion confidential business information, such
pumps submitted by device as a manufacturing process. Please note
AGENCY: Food and Drug Administration, that if you include your name, contact
HHS. manufacturers, continues to provide the
Agency’s current thinking on this topic. information, or other information that
ACTION: Notice; withdrawal. identifies you in the body of your
Dated: August 2, 2017.
SUMMARY: The Food and Drug comments, that information will be
Anna K. Abram, posted on https://www.regulations.gov.
Administration (FDA) is announcing the
withdrawal of a notice that was
Deputy Commissioner for Policy, Planning, • If you want to submit a comment
Legislation, and Analysis. with confidential information that you
published in the Federal Register of [FR Doc. 2017–16561 Filed 8–4–17; 8:45 am]
March 15, 2017. do not wish to be made available to the
BILLING CODE 4164–01–P public, submit the comment as a
DATES: August 7, 2017.
written/paper submission and in the
FOR FURTHER INFORMATION CONTACT: manner detailed (see ‘‘Written/Paper
Amber Sanford, Office of Operations, DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration, Three HUMAN SERVICES
White Flint North, 10A63, 11601 Written/Paper Submissions
Landsdown St., North Bethesda, MD Food and Drug Administration
Submit written/paper submissions as
20852, 301–796–8867, PRAStaff@ [Docket No. FDA–2007–D–0369] follows:
fda.hhs.gov. • Mail/Hand delivery/Courier (for
SUPPLEMENTARY INFORMATION: In a notice Product-Specific Guidances; Final written/paper submissions): Dockets
published in the Federal Register of Guidances for Industry; Availability Management Staff (HFA–305), Food and
March 15, 2017 (82 FR 13817), ‘‘Agency AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers
Information Collection Activities; HHS. Lane, Rm. 1061, Rockville, MD 20852.
Proposed Collection; Comment Request; ACTION: Notice of availability. • For written/paper comments
Safety Assurance Case,’’ FDA requested submitted to the Dockets Management
comment on the information collection SUMMARY: The Food and Drug Staff, FDA will post your comment, as
mstockstill on DSK30JT082PROD with NOTICES
associated with safety assurance cases Administration (FDA or Agency) is well as any attachments, except for
(SACs). announcing the availability of final information submitted, marked and
Under the Paperwork Reduction Act product-specific guidances. The identified, as confidential, if submitted
of 1995 (PRA), Federal Agencies are guidances provide product-specific as detailed in ‘‘Instructions.’’
required to publish notice in the recommendations on, among other Instructions: All submissions received
Federal Register concerning each things, the design of bioequivalence must include the Docket No. FDA–
proposed collection of information, (BE) studies to support abbreviated new 2007–D–0369 for ‘‘Product-Specific
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![36794 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
Dated: August 2, 2017. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Anna K. Abram, https://www.regulations.gov. Follow the Agency will review this copy, including
Deputy Commissioner for Policy, Planning, instructions for submitting comments. the claimed confidential information, in
Legislation, and Analysis. Comments submitted electronically, its consideration of comments. The
[FR Doc. 2017–16581 Filed 8–4–17; 8:45 am] including attachments, to https:// second copy, which will have the
BILLING CODE 4164–01–P www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
DEPARTMENT OF HEALTH AND solely responsible for ensuring that your https://www.regulations.gov. Submit
HUMAN SERVICES comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
Food and Drug Administration third party may not wish to be posted, contact information to be made publicly
[Docket Nos. FDA–2016–E–2171, FDA– such as medical information, your or available, you can provide this
2016–E–2169, and FDA–2016–E–2170] anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Determination of Regulatory Review as a manufacturing process. Please note must identify this information as
Period for Purposes of Patent that if you include your name, contact ‘‘confidential.’’ Any information marked
Extension; VONVENDI information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
AGENCY: Food and Drug Administration, comments, that information will be
HHS. and other applicable disclosure law. For
posted on https://www.regulations.gov. more information about FDA’s posting
ACTION: Notice. • If you want to submit a comment of comments to public dockets, see 80
SUMMARY: The Food and Drug with confidential information that you FR 56469, September 18, 2015, or access
Administration (FDA or the Agency) has do not wish to be made available to the the information at: https://www.gpo.gov/
determined the regulatory review period public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
for VONVENDI and is publishing this written/paper submission and in the 23389.pdf.
notice of that determination as required manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
by law. FDA has made the Submissions’’ and ‘‘Instructions’’). read background documents or the
determination because of the Written/Paper Submissions electronic and written/paper comments
submission of applications to the received, go to https://
Submit written/paper submissions as
Director of the U.S. Patent and www.regulations.gov and insert the
follows:
Trademark Office (USPTO), Department docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
of Commerce, for the extension of a heading of this document, into the
written/paper submissions): Dockets
patent which claims that human ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and
biological product. and/or go to the Dockets Management
Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852.
of the dates as published (in the • For written/paper comments Rockville, MD 20852.
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
incorrect may submit either electronic Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory
or written comments and ask for a well as any attachments, except for Policy, Food and Drug Administration,
redetermination by October 6, 2017. information submitted, marked and 10903 New Hampshire Ave., Bldg. 51,
Furthermore, any interested person may identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993,
petition FDA for a determination as detailed in ‘‘Instructions.’’ 301–796–3600.
regarding whether the applicant for Instructions: All submissions received SUPPLEMENTARY INFORMATION:
extension acted with due diligence must include the Docket Nos. FDA–
during the regulatory review period by 2016–E–2171, FDA–2016–E–2169, and I. Background
February 5, 2018. See ‘‘Petitions’’ in the FDA–2016–E–2170 for ‘‘Determination The Drug Price Competition and
SUPPLEMENTARY INFORMATION section for of Regulatory Review Period for Patent Term Restoration Act of 1984
more information. Purposes of Patent Extension; (Pub. L. 98–417) and the Generic
ADDRESSES: You may submit comments VONVENDI.’’ Received comments, Animal Drug and Patent Term
as follows. Please note that late, those filed in a timely manner (see Restoration Act (Pub. L. 100–670)
untimely filed comments will not be ADDRESSES), will be placed in the docket generally provide that a patent may be
considered. Electronic comments must and, except for those submitted as extended for a period of up to 5 years
be submitted on or before October 6, ‘‘Confidential Submissions,’’ publicly so long as the patented item (human
2017. The https://www.regulations.gov viewable at https://www.regulations.gov drug product, animal drug product,
electronic filing system will accept or at the Dockets Management Staff medical device, food additive, or color
comments until midnight Eastern Time between 9 a.m. and 4 p.m., Monday additive) was subject to regulatory
at the end of October 6, 2017. Comments through Friday. review by FDA before the item was
received by mail/hand delivery/courier • Confidential Submissions—To marketed. Under these acts, a product’s
(for written/paper submissions) will be submit a comment with confidential regulatory review period forms the basis
considered timely if they are information that you do not wish to be for determining the amount of extension
mstockstill on DSK30JT082PROD with NOTICES
postmarked or the delivery service made publicly available, submit your an applicant may receive.
acceptance receipt is on or before that comments only as a written/paper A regulatory review period consists of
date. submission. You should submit two two periods of time: A testing phase and
copies total. One copy will include the an approval phase. For human
Electronic Submissions information you claim to be confidential biological products, the testing phase
Submit electronic comments in the with a heading or cover note that states begins when the exemption to permit
following way: ‘‘THIS DOCUMENT CONTAINS the clinical investigations of the
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Document Created: 2017-08-05 02:59:38
Document Modified: 2017-08-05 02:59:38
| 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 Agency guidances at any time. | |
| Contact | Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850. | |
| FR Citation | 82 FR 36792 |
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