2022-06034. Agency Information Collection Activities; Proposed Collection; Comment Request; Medication Guides for Prescription Drug Products

AGENCY:

Food and Drug Administration, Department of Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) 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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with Medication Guides for prescription drug products.

DATES:

Submit either electronic or written comments on the collection of information by May 23, 2022.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 23, 2022. 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 Docket No. FDA-2011-N-0902 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Medication Guide Requirements for Prescription Drug Product Labeling.” 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, 240-402-7500.

• 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.govinfo.gov/​content/​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, 240-402-7500.

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, [e-mail].

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3521), 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 revision 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.

Medication Guide Requirements for Prescription Drug Product Labeling

OMB Control Number 0910-0393—Extension

This information collection supports FDA regulations pertaining to the distribution of patient labeling, called Medication Guides, for human prescription drug and biological products used primarily on an outpatient basis, and required for products that pose a serious and significant public health concern. Applicable regulations are codified at 21 CFR part 208: Medication Guides for Prescription Drug Products, and set forth general content and format requirements, as well as provide for exemptions and deferrals. Medication Guides provide patients with important written information about drug products, including the drug's approved uses, contraindications, adverse drug reactions, and cautions for specific populations, and are required in accordance with Agency regulations.

To assist consumers and industry with understanding applicable regulatory requirements in 21 CFR part 208 pertaining to developing, distributing, and submitting certain Medication Guides, we have developed the guidance document entitled “Medication Guides—Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)” (available at https://www.fda.gov/​media/​79776/​download ). The guidance document includes a discussion of the applicable regulations; FDA enforcement policy with regard to Medication Guides associated with products dispensed to healthcare professionals, or patient caregivers, instead of being dispensed directly to the patient for self-administration; and Medication Guides required as part of a risk evaluation and mitigation strategy.

We estimate the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

Activity; 21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Content and format of a Medication Guide; § 208.20	41	1	41	320	13,120
Exemptions and deferrals; § 208.26(a)	1	1	1	4	4
Total			42		13,124
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Upon evaluation of the information collection, we have removed burden we attributed to reporting associated with supplements and other changes to approved abbreviated new drug applications, new drug applications, and biologics license applications (21 CFR 314.70(b)(3)(ii) and 601.12(f)). We now account for burden associated with these regulatory provisions in OMB control numbers 0910-0001 and 0910-0338 and have decreased the burden associated with this collection accordingly.

Table 2—Estimated Annual Third-Party Disclosure Burden ¹

Activity; 21 CFR section	Number of respondents	Number of disclosures per respondent	Total annual disclosures	Average burden per disclosure 2	Total hours
Distribute Medication Guides to authorized dispensers; § 208.24(c)	191	9,000	1,719,000	1.25	2,148,750
Distribute and Dispense Medication Guides to Patients; § 208.24(e)	88,000	5,705	502,040,000	0.05 (3 minutes)	25,102,000
Total			503,759,000		27,250,750
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
2  Numbers may not sum due to rounding.

We have decreased our estimated burden associated with disclosures to reflect a decrease in related submissions over the past 3 years.

Dated: March 14, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.