83 FR 16108 - Agency Information Collection Activities; Proposed Collection; Comment Request; Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 72 (April 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 72 (April 13, 2018)
| Page Range | 16108-16110 | |
| FR Document | 2018-07684 |
[Federal Register Volume 83, Number 72 (Friday, April 13, 2018)] [Notices] [Pages 16108-16110] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07684] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1111] Agency Information Collection Activities; Proposed Collection; Comment Request; Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological 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 ``Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products.'' DATES: Submit either electronic or written comments on the collection of information by June 12, 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 June 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 12, 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-2018-N-1111 for ``Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological 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 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 [[Page 16109]] 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. Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products--21 CFR 310.306, 314.81(b)(3)(iii), and 600.82 OMB Control Number 0910-0759--Extension Sections 310.306, 314.81(b)(3)(iii), and 600.82 (21 CFR 310.306, 314.81(b)(3)(iii), and 600.82) were modified to implement sections 506C and 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c and 356e) as amended by the Food and Drug Administration Safety and Innovation Act. Under these sections, applicants with an approved new drug application (NDA) or abbreviated new drug application (ANDA) for a covered drug product, manufacturers of a covered drug product marketed without an approved application, and applicants with an approved biologics license application (BLA) for a covered biological product (including certain applications of blood or blood components) must notify FDA in writing of a permanent discontinuance of the manufacture of the drug or biological product, or an interruption in manufacturing of the drug or biological product, that is likely to lead to a meaningful disruption in the applicant's supply (or a significant disruption for blood or blood components) of that product. The notification is required if the drug or biological product is life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including use in emergency medical care or during surgery, and if the drug or biological product is not a radiopharmaceutical drug product. The regulations also require that the notification include the following information: (1) The name of the drug or biological product subject to the notification, including the National Drug Code Directory (NDC) (or, for a biological product that does not have an NDC, an alternative standard for identification and labeling that has been recognized as acceptable by the Center Director); (2) the name of each applicant of the drug or biological product; (3) whether the notification relates to a permanent discontinuance of the drug or biological product or an interruption in manufacturing of the product; (4) a description of the reason for the permanent discontinuance or interruption in manufacturing; and (5) the estimated duration of the interruption in manufacturing. The notification must be submitted to FDA electronically at least 6 months prior to the date of the permanent discontinuance or interruption in manufacturing. If 6 months' advance notice is not possible because the permanent discontinuance or interruption in manufacturing was unanticipated 6 months in advance, the applicant must notify FDA as soon as practicable, but in no case later than 5 business days after the permanent discontinuance or interruption in manufacturing occurs. If an applicant fails to submit the required notification, FDA will issue a letter informing the applicant or manufacturer of its noncompliance. The applicant must submit to FDA, not later than 30 calendar days after FDA issues the letter, a written response setting forth the basis for noncompliance and providing the required notification. Description of Respondents: Applicants of prescription drugs and biological products subject to an approved NDA, ANDA, or BLA, and manufacturers of prescription drug products marketed without an approved ANDA or NDA, if the product is life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including use in emergency medical care or during surgery, or is not a radiopharmaceutical product. If the BLA applicant is a manufacturer of blood or blood components, it is only subject to these regulations if it manufactures a significant percentage of the nation's blood supply. Burden Estimates: Based on the number of drug and biological product shortage related notifications we have seen in the past 12 months, we estimate that annually a total of approximately 75 respondents (``No. of Respondents'' in table 1) will notify us of a permanent discontinuance of the manufacture of a drug or biological product or an interruption in manufacturing of a drug or biological product that is likely to lead to a meaningful disruption in the respondent's supply of that product. We estimate that these respondents will submit annually a total of approximately 352.5 notifications as required under Sec. Sec. 310.306, 314.81(b)(3)(iii), and 600.82. We estimate 4.7 notifications per respondent, because a respondent may experience multiple discontinuances or interruptions in manufacturing in a year that require notification (``No. of Responses per Respondent'' in table 1). We also estimate that preparing and submitting these notifications to FDA will take approximately 2 hours per respondent (``Average Burden per Response'' in table 1). FDA estimates the burden of this collection of information as follows: [[Page 16110]] Table 1--Estimated Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Notifications required under Sec. Sec. 310.306 (unapproved 75 4.7 352.5 2 705 drugs), 314.81(b)(3)(iii) (products approved under an NDA or ANDA), and 600.82 (products approved under a BLA)................. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated burden for this information collection has changed since the previous OMB approval. The current burden is based on the number of actual new notifications received including notifications that were counted previously under the OMB approval for the interim final rule entitled ``Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products'' (80 FR 38915, July 8, 2015) (OMB control number 0910-0699). Dated: April 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07684 Filed 4-12-18; 8:45 am] BILLING CODE 4164-01-P
![16108 Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Notices
number 0910–0485; the collections of electronic filing system will accept Dockets Management Staff between 9
information in 21 CFR part 814, comments until midnight Eastern Time a.m. and 4 p.m., Monday through
subparts A through E, regarding at the end of June 12, 2018. Comments Friday.
premarket approval, have been received by mail/hand delivery/courier • Confidential Submissions—To
approved under OMB control number (for written/paper submissions) will be submit a comment with confidential
0910–0231; the collections of considered timely if they are information that you do not wish to be
information in 21 CFR part 820, postmarked or the delivery service made publicly available, submit your
regarding the quality system regulation, acceptance receipt is on or before that comments only as a written/paper
have been approved under OMB control date. submission. You should submit two
number 0910–0073; and the collections copies total. One copy will include the
Electronic Submissions information you claim to be confidential
of information in the guidance
document ‘‘Requests for Feedback on Submit electronic comments in the with a heading or cover note that states
Medical Device Submissions: The Pre- following way: ‘‘THIS DOCUMENT CONTAINS
Submission Program and Meetings with • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Food and Drug Administration Staff’’ https://www.regulations.gov. Follow the Agency will review this copy, including
have been approved under OMB control instructions for submitting comments. the claimed confidential information, in
number 0910–0756. Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
Dated: April 9, 2018.
www.regulations.gov will be posted to claimed confidential information
Leslie Kux, the docket unchanged. Because your redacted/blacked out, will be available
Associate Commissioner for Policy. comment will be made public, you are for public viewing and posted on
[FR Doc. 2018–07687 Filed 4–12–18; 8:45 am] solely responsible for ensuring that your https://www.regulations.gov. Submit
BILLING CODE 4164–01–P 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
third party may not wish to be posted, contact information to be made publicly
DEPARTMENT OF HEALTH AND such as medical information, your or available, you can provide this
HUMAN SERVICES 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
Food and Drug Administration as a manufacturing process. Please note must identify this information as
[Docket No. FDA–2018–N–1111] that if you include your name, contact ‘‘confidential.’’ Any information marked
information, or other information that as ‘‘confidential’’ will not be disclosed
Agency Information Collection identifies you in the body of your except in accordance with 21 CFR 10.20
Activities; Proposed Collection; comments, that information will be and other applicable disclosure law. For
Comment Request; Permanent posted on https://www.regulations.gov. more information about FDA’s posting
Discontinuation or Interruption in • If you want to submit a comment of comments to public dockets, see 80
Manufacturing of Certain Drug and with confidential information that you FR 56469, September 18, 2015, or access
Biological Products do not wish to be made available to the the information at: https://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
AGENCY: Food and Drug Administration,
written/paper submission and in the 23389.pdf.
HHS.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
ACTION: Notice. Submissions’’ and ‘‘Instructions’’). read background documents or the
SUMMARY: The Food and Drug Written/Paper Submissions electronic and written/paper comments
Administration (FDA or Agency) is received, go to https://
Submit written/paper submissions as www.regulations.gov and insert the
announcing an opportunity for public
follows: docket number, found in brackets in the
comment on the proposed collection of • Mail/Hand delivery/Courier (for
certain information by the Agency. heading of this document, into the
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Under the Paperwork Reduction Act of Management Staff (HFA–305), Food and
1995 (PRA), Federal Agencies are and/or go to the Dockets Management
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
required to publish notice in the Lane, Rm. 1061, Rockville, MD 20852.
Federal Register concerning each Rockville, MD 20852.
• For written/paper comments
proposed collection of information, FOR FURTHER INFORMATION CONTACT:
submitted to the Dockets Management
including each proposed extension of an Staff, FDA will post your comment, as Domini Bean, Office of Operations,
existing collection of information, and well as any attachments, except for Food and Drug Administration, Three
to allow 60 days for public comment in information submitted, marked and White Flint North, 10A–12M, 11601
response to the notice. This notice identified, as confidential, if submitted Landsdown St., North Bethesda, MD
solicits comments on ‘‘Permanent as detailed in ‘‘Instructions.’’ 20852, 301–796–5733, PRAStaff@
Discontinuation or Interruption in Instructions: All submissions received fda.hhs.gov.
Manufacturing of Certain Drug and must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
Biological Products.’’ 2018–N–1111 for ‘‘Permanent PRA (44 U.S.C. 3501–3520), Federal
DATES: Submit either electronic or Discontinuation or Interruption in Agencies must obtain approval from the
written comments on the collection of Manufacturing of Certain Drug and Office of Management and Budget
daltland on DSKBBV9HB2PROD with NOTICES
information by June 12, 2018. Biological Products.’’ Received (OMB) for each collection of
ADDRESSES: You may submit comments comments, those filed in a timely information they conduct or sponsor.
as follows. Please note that late, manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
untimely filed comments will not be in the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
considered. Electronic comments must submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
be submitted on or before June 12, 2018. Submissions,’’ publicly viewable at or requirements that members of the
The https://www.regulations.gov https://www.regulations.gov or at the public submit reports, keep records, or
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![16110 Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Notices
TABLE 1—ESTIMATED REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
Notifications required under §§ 310.306 (unapproved
drugs), 314.81(b)(3)(iii) (products approved under an
NDA or ANDA), and 600.82 (products approved under a
BLA) .................................................................................. 75 4.7 352.5 2 705
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated burden for this FDA for recognition, and how FDA information submitted, marked and
information collection has changed would review such applications and identified, as confidential, if submitted
since the previous OMB approval. The periodically reevaluate recognized as detailed in ‘‘Instructions.’’
current burden is based on the number databases. Instructions: All submissions received
of actual new notifications received DATES: The announcement of the must include the Docket No. FDA–
including notifications that were guidance is published in the Federal 2016–D–1233 for ‘‘Use of Public Human
counted previously under the OMB Register on April 13, 2018. Genetic Variant Databases to Support
approval for the interim final rule Clinical Validity for Genetic and
ADDRESSES: You may submit either
entitled ‘‘Permanent Discontinuance or Genomic-Based In Vitro Diagnostics;
electronic or written comments on
Interruption in Manufacturing of Certain Guidance for Stakeholders and Food
Agency guidances at any time as
Drug or Biological Products’’ (80 FR and Drug Administration Staff.’’
follows:
38915, July 8, 2015) (OMB control Received comments will be placed in
number 0910–0699). Electronic Submissions the docket and, except for those
Dated: April 9, 2018. Submit electronic comments in the submitted as ‘‘Confidential
Leslie Kux, following way: Submissions,’’ publicly viewable at
Associate Commissioner for Policy. • Federal eRulemaking Portal: https://www.regulations.gov or at the
[FR Doc. 2018–07684 Filed 4–12–18; 8:45 am] https://www.regulations.gov. Follow the Dockets Management Staff office
BILLING CODE 4164–01–P
instructions for submitting comments. between 9 a.m. and 4 p.m., Monday
Comments submitted electronically, through Friday.
including attachments, to https://
• Confidential Submissions—To
DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to
the docket unchanged. Because your submit a comment with confidential
HUMAN SERVICES information that you do not wish to be
comment will be made public, you are
solely responsible for ensuring that your made publicly available, submit your
Food and Drug Administration
comment does not include any comments only as a written/paper
[Docket No. FDA–2016–D–1233]
confidential information that you or a submission. You should submit two
third party may not wish to be posted, copies total. One copy will include the
Use of Public Human Genetic Variant information you claim to be confidential
Databases To Support Clinical Validity such as medical information, your or
anyone else’s Social Security number, or with a heading or cover note that states
for Genetic and Genomic-Based In ‘‘THIS DOCUMENT CONTAINS
Vitro Diagnostics; Guidance for confidential business information, such
as a manufacturing process. Please note CONFIDENTIAL INFORMATION.’’ The
Stakeholders and Food and Drug Agency will review this copy, including
Administration Staff; Availability that if you include your name, contact
information, or other information that the claimed confidential information, in
AGENCY: Food and Drug Administration, identifies you in the body of your its consideration of comments. The
HHS. comments, that information will be second copy, which will have the
ACTION: Notice of availability. posted on https://www.regulations.gov. claimed confidential information
• If you want to submit a comment redacted/blacked out, will be available
SUMMARY: The Food and Drug with confidential information that you for public viewing and posted on
Administration (FDA or Agency) is do not wish to be made available to the https://www.regulations.gov. Submit
announcing the availability of the final public, submit the comment as a both copies to the Dockets Management
guidance entitled ‘‘Use of Public Human written/paper submission and in the Staff. If you do not wish your name and
Genetic Variant Databases to Support manner detailed (see ‘‘Written/Paper contact information to be made publicly
Clinical Validity for Genetic and Submissions’’ and ‘‘Instructions’’). available, you can provide this
Genomic-Based In Vitro Diagnostics; information on the cover sheet and not
Guidance for Stakeholders and Food Written/Paper Submissions in the body of your comments and you
and Drug Administration Staff.’’ This Submit written/paper submissions as must identify this information as
guidance document describes how follows: ‘‘confidential.’’ Any information marked
publicly accessible databases of human • Mail/Hand delivery/Courier (for as ‘‘confidential’’ will not be disclosed
genetic variants can serve as sources of written/paper submissions): Dockets except in accordance with 21 CFR 10.20
daltland on DSKBBV9HB2PROD with NOTICES
valid scientific evidence to support the Management Staff (HFA–305), Food and and other applicable disclosure law. For
clinical validity of genotype-phenotype Drug Administration, 5630 Fishers more information about FDA’s posting
relationships in FDA’s regulatory review Lane, Rm. 1061, Rockville, MD 20852. of comments to public dockets, see 80
of genetic and genomic-based tests. This • For written/paper comments FR 56469, September 18, 2015, or access
guidance further outlines the process by submitted to the Dockets Management the information at: https://www.gpo.gov/
which administrators of genetic variant Staff, FDA will post your comment, as fdsys/pkg/FR-2015-09-18/pdf/2015-
databases could voluntarily apply to well as any attachments, except for 23389.pdf.
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Document Created: 2018-04-13 00:17:54
Document Modified: 2018-04-13 00:17:54
| 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 June 12, 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 16108 |
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