83 FR 54110 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 208 (October 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 208 (October 26, 2018)
| Page Range | 54110-54112 | |
| FR Document | 2018-23422 |
[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)] [Notices] [Pages 54110-54112] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23422] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0902] Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements 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 regulations requiring distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern. DATES: Submit either electronic or written comments on the collection of information by December 26, 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 December 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 26, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2011-N-0902 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements.'' 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 [[Page 54111]] 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: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Prescription Drug Product Labeling; Medication Guide Requirements OMB Control Number 0910-0393-Extension FDA regulations require the distribution of patient labeling, called Medication Guides, for certain prescription human drug and biological products used primarily on an outpatient basis that pose a serious and significant public health concern. Medication Guides provide patients the most important information about drug products, including the drugs' approved uses, contraindications, adverse drug reactions, and cautions for specific populations. These regulations are intended to improve the public health by providing information necessary for patients to use certain medications safely and effectively. The regulations contain the following reporting requirements that are subject to the PRA: 21 CFR 208.20--Applicants must submit draft Medication Guides for FDA approval according to the prescribed content and format. 21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)--Application holders must submit changes to Medication Guides as supplements to their applications to FDA for approval. 21 CFR 208.24(c)--Each distributor or packer who receives Medication Guides, or the means to produce Medication Guides, from a manufacturer under paragraph (b) of this section shall provide those Medication Guides to each authorized dispenser to whom it ships a drug product. 21 CFR 208.24(e)--Each authorized dispenser of a prescription drug product for which a Medication Guide is required must provide a Medication Guide directly to each patient when dispensing the product to the patient or to the patient's agent, unless an exemption applies under 21 CFR 208.26. 21 CFR 208.26(a)--Requests may be submitted for an exemption or a deferral from particular Medication Guide content or format requirements. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Content and Format of a 61 1 61 320 19,520 Medication Guide--Sec. 208.20 Supplements and Other Changes to 155 1 155 72 11,160 an Approved Application--Sec. Sec. 314.70(b)(3)(ii) and 601.12(f)...................... Exemptions and Deferrals--Sec. 1 1 1 4 4 208.26(a)...................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 30,684 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure ---------------------------------------------------------------------------------------------------------------- Distributing Medication Guide 191 9,000 1,719,000 1.25 2,148,750 to Authorized Dispenser--Sec. 208.24(c).................. [[Page 54112]] Distributing and Dispensing a 88,736 5,705 506,238,880 * 0.05 25,311,944 Medication Guide to Patient-- Sec. 208.24(e)............. --------------------------------------------------------------------------------- Total..................... .............. ................ .............. .............. 27,460,694 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. * 3 minutes. Our estimated annual reporting burden for the information collection reflects an increase of 51 respondents and responses and a corresponding overall increase of 4,664 total hours. We attribute this adjustment to an increase in the number of submissions we received over the last few years. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our annual third-party disclosure burden estimate, except for correction in calculations. Dated: October 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23422 Filed 10-25-18; 8:45 am] BILLING CODE 4164-01-P
![54110 Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
U.S.C. 262): March 23, 2015. FDA has DEPARTMENT OF HEALTH AND such as medical information, your or
verified the applicant’s claim that the HUMAN SERVICES anyone else’s Social Security number, or
biologics license application (BLA) for confidential business information, such
TALTZ (BLA 125521) was initially Food and Drug Administration as a manufacturing process. Please note
submitted on March 23, 2015. [Docket No. FDA–2011–N–0902] that if you include your name, contact
information, or other information that
3. The date the application was
Agency Information Collection identifies you in the body of your
approved: March 22, 2016. FDA has comments, that information will be
Activities; Proposed Collection;
verified the applicant’s claim that BLA posted on https://www.regulations.gov.
Comment Request; Prescription Drug
125521 was approved on March 22,
Product Labeling; Medication Guide • If you want to submit a comment
2016. Requirements with confidential information that you
This determination of the regulatory do not wish to be made available to the
review period establishes the maximum AGENCY: Food and Drug Administration, public, submit the comment as a
HHS. written/paper submission and in the
potential length of a patent extension.
However, the USPTO applies several ACTION: Notice. manner detailed (see ‘‘Written/Paper
statutory limitations in its calculations Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug
of the actual period for patent extension. Administration (FDA or Agency) is Written/Paper Submissions
In its applications for patent extension, announcing an opportunity for public Submit written/paper submissions as
this applicant seeks 1,156 days or 935 comment on the proposed collection of follows:
days of patent term extension. certain information by the Agency. • Mail/Hand Delivery/Courier (for
Under the Paperwork Reduction Act of written/paper submissions): Dockets
III. Petitions 1995 (PRA), Federal Agencies are Management Staff (HFA–305), Food and
Anyone with knowledge that any of required to publish notice in the Drug Administration, 5630 Fishers
the dates as published are incorrect may Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852.
submit either electronic or written proposed collection of information, • For written/paper comments
including each proposed extension of an submitted to the Dockets Management
comments and, under 21 CFR 60.24, ask
existing collection of information, and Staff, FDA will post your comment, as
for a redetermination (see DATES).
to allow 60 days for public comment in well as any attachments, except for
Furthermore, as specified in § 60.30 (21
response to the notice. This notice information submitted, marked and
CFR 60.30), any interested person may solicits comments on regulations identified, as confidential, if submitted
petition FDA for a determination requiring distribution of patient as detailed in ‘‘Instructions.’’
regarding whether the applicant for labeling, called Medication Guides, for Instructions: All submissions received
extension acted with due diligence certain products that pose a serious and must include the Docket No. FDA–
during the regulatory review period. To significant public health concern. 2011–N–0902 for ‘‘Agency Information
meet its burden, the petition must DATES: Submit either electronic or Collection Activities; Proposed
comply with all the requirements of written comments on the collection of Collection; Comment Request;
§ 60.30, including but not limited to: information by December 26, 2018. Prescription Drug Product Labeling;
Must be timely (see DATES), must be ADDRESSES: You may submit comments Medication Guide Requirements.’’
filed in accordance with § 10.20, must as follows. Please note that late, Received comments, those filed in a
contain sufficient facts to merit an FDA untimely filed comments will not be timely manner (see ADDRESSES), will be
investigation, and must certify that a considered. Electronic comments must placed in the docket and, except for
true and complete copy of the petition be submitted on or before December 26, those submitted as ‘‘Confidential
has been served upon the patent 2018. The https://www.regulations.gov Submissions,’’ publicly viewable at
applicant. (See H. Rept. 857, part 1, 98th electronic filing system will accept https://www.regulations.gov or at the
Cong., 2d sess., pp. 41–42, 1984.) comments until 11:59 p.m. Eastern Time Dockets Management Staff between 9
Petitions should be in the format at the end of December 26, 2018. a.m. and 4 p.m., Monday through
specified in 21 CFR 10.30. Comments received by mail/hand Friday.
delivery/courier (for written/paper • Confidential Submissions—To
Submit petitions electronically to submit a comment with confidential
https://www.regulations.gov at Docket submissions) will be considered timely
if they are postmarked or the delivery information that you do not wish to be
No. FDA–2013–S–0610. Submit written made publicly available, submit your
service acceptance receipt is on or
petitions (two copies are required) to the comments only as a written/paper
before that date.
Dockets Management Staff (HFA–305), submission. You should submit two
Food and Drug Administration, 5630 Electronic Submissions copies total. One copy will include the
Fishers Lane, Rm. 1061, Rockville, MD Submit electronic comments in the information you claim to be confidential
20852. following way: with a heading or cover note that states
Dated: October 22, 2018. • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Leslie Kux,
instructions for submitting comments. Agency will review this copy, including
Associate Commissioner for Policy. Comments submitted electronically, the claimed confidential information, in
[FR Doc. 2018–23438 Filed 10–25–18; 8:45 am] including attachments, to https:// its consideration of comments. The
khammond on DSK30JT082PROD with NOTICES
BILLING CODE 4164–01–P www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on
comment does not include any https://www.regulations.gov. Submit
confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
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![54112 Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Average
Number of Total annual
21 CFR section disclosures burden per Total hours
respondents disclosures
per respondent disclosure
Distributing and Dispensing a Medication Guide to Pa-
tient—§ 208.24(e) ......................................................... 88,736 5,705 506,238,880 * 0.05 25,311,944
Total .......................................................................... ........................ ............................ ........................ ........................ 27,460,694
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 3 minutes.
Our estimated annual reporting Furthermore, any interested person may Written/Paper Submissions
burden for the information collection petition FDA for a determination Submit written/paper submissions as
reflects an increase of 51 respondents regarding whether the applicant for follows:
and responses and a corresponding extension acted with due diligence • Mail/Hand delivery/Courier (for
overall increase of 4,664 total hours. We during the regulatory review period by written/paper submissions): Dockets
attribute this adjustment to an increase April 24, 2019. See ‘‘Petitions’’ in the Management Staff (HFA–305), Food and
in the number of submissions we SUPPLEMENTARY INFORMATION section for Drug Administration, 5630 Fishers
received over the last few years. Based more information. Lane, Rm. 1061, Rockville, MD 20852.
on a review of the information ADDRESSES: You may submit comments • For written/paper comments
collection since our last request for as follows. Please note that late, submitted to the Dockets Management
OMB approval, we have made no untimely filed comments will not be Staff, FDA will post your comment, as
adjustments to our annual third-party considered. Electronic comments must well as any attachments, except for
disclosure burden estimate, except for be submitted on or before December 26, information submitted, marked and
correction in calculations. 2018. The https://www.regulations.gov identified, as confidential, if submitted
Dated: October 22, 2018. electronic filing system will accept as detailed in ‘‘Instructions.’’
Leslie Kux, comments until 11:59 p.m. Eastern Time Instructions: All submissions received
Associate Commissioner for Policy. at the end of December 26, 2018. must include the Docket Nos. FDA–
[FR Doc. 2018–23422 Filed 10–25–18; 8:45 am]
Comments received by mail/hand 2017–E–6904 and FDA–2017–E–6909—
delivery/courier (for written/paper for ’’Determination of Regulatory
BILLING CODE 4164–01–P
submissions) will be considered timely Review Period for Purposes of Patent
if they are postmarked or the delivery Extension; REBINYN.’’ Received
DEPARTMENT OF HEALTH AND service acceptance receipt is on or comments, those filed in a timely
HUMAN SERVICES before that date. manner (see ADDRESSES), will be placed
in the docket and, except for those
Electronic Submissions
Food and Drug Administration submitted as ‘‘Confidential
Submit electronic comments in the Submissions,’’ publicly viewable at
[Docket Nos. FDA–2017–E–6904 and FDA– following way:
2017–E–6909]
https://www.regulations.gov or at the
• Federal eRulemaking Portal: https:// Dockets Management Staff between 9
Determination of Regulatory Review www.regulations.gov. Follow the a.m. and 4 p.m., Monday through
Period for Purposes of Patent instructions for submitting comments. Friday.
Extension; REBINYN Comments submitted electronically, • Confidential Submissions—To
including attachments, to https:// submit a comment with confidential
AGENCY: Food and Drug Administration, www.regulations.gov will be posted to information that you do not wish to be
HHS. the docket unchanged. Because your made publicly available, submit your
ACTION: Notice. comment will be made public, you are comments only as a written/paper
solely responsible for ensuring that your submission. You should submit two
SUMMARY: The Food and Drug comment does not include any copies total. One copy will include the
Administration (FDA or the Agency) has confidential information that you or a information you claim to be confidential
determined the regulatory review period third party may not wish to be posted, with a heading or cover note that states
for REBINYN and is publishing this such as medical information, your or ‘‘THIS DOCUMENT CONTAINS
notice of that determination as required anyone else’s Social Security number, or CONFIDENTIAL INFORMATION.’’ The
by law. FDA has made the confidential business information, such Agency will review this copy, including
determination because of the as a manufacturing process. Please note the claimed confidential information, in
submission of applications to the that if you include your name, contact its consideration of comments. The
Director of the U.S. Patent and information, or other information that second copy, which will have the
Trademark Office (USPTO), Department identifies you in the body of your claimed confidential information
of Commerce, for the extension of a comments, that information will be redacted/blacked out, will be available
patent which claims that human posted on https://www.regulations.gov. for public viewing and posted on
khammond on DSK30JT082PROD with NOTICES
biological product. • If you want to submit a comment https://www.regulations.gov. Submit
DATES: Anyone with knowledge that any with confidential information that you both copies to the Dockets Management
of the dates as published (see the do not wish to be made available to the Staff. If you do not wish your name and
SUPPLEMENTARY INFORMATION section) are public, submit the comment as a contact information to be made publicly
incorrect may submit either electronic written/paper submission and in the available, you can provide this
or written comments and ask for a manner detailed (see ‘‘Written/Paper information on the cover sheet and not
redetermination by December 26, 2018. Submissions’’ and ‘‘Instructions’’). in the body of your comments and you
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Document Created: 2018-10-26 02:29:13
Document Modified: 2018-10-26 02:29:13
| 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 December 26, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 54110 |
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