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
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 |