0393 PMGs SSA 2019 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Prescription Drug Product Labeling
Medication Guide Requirements
OMB Control No. 0910-0393
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us or we)
regulations pertaining to 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. The regulations are codified at 21 CFR
part 208 (21 CFR 208): Medication Guides for Prescription Drug Products, and set forth general
requirements including both content and format, as well as provide for exemptions and deferrals.
Medication Guides provide patients important 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 both consumers and industry with understanding the applicable regulatory requirements
and purpose of Medication Guides, we have developed resources and made them available on
our website at www.fda.gov. Among the resources we include the guidance document entitled,
“Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and
Mitigation Strategies (REMS)”; as well as a discussion of the distinction between Medication
Guides and Consumer Medication information. The regulations, guidance, and informational
resources are intended to improve the public health by enabling patients to use certain
medications most safely and effectively.
Accordingly, we are requesting extension of OMB approval for the information collection
provisions under 21 CFR 208 and discussed in the supporting statement.
2. Purpose and Use of the Information Collection
As part of the new drug application process (21 CFR 314), FDA reviews Medication Guides to
determine whether the labeling for certain prescription drug products and biological products
comply with the applicable regulations. In turn, the information will then inform patients to
whom these products are administered thereby promoting the safe and effective use of human
prescription drug and biological products.
3. Use of Improved Information Technology and Burden Reduction
Labeling under part 208 may be submitted in electronic format provided it is submitted in a form
that FDA can process, review, and archive. Because the labeling is submitted as part of the

application process for NDAs, BLAs, and ANDAs, we believe this helps minimize burden on
respondents. FDA provides resources to industry, including guidance, regarding the submission
of information in electronic format. These resources are available on our website at
https://www.fda.gov/Drugs/ResourcesForYou/Industry/default.htm.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Although other ICRs cover specific
labeling requirements (OMB control numbers 0910-0001, 0910-0338, and 0910-0572), this ICR
specifically relates to the collection of information associated with human prescription drugs,
including biological products, subject to part 208.
5. Impact on Small Businesses or Other Small Entities
No undue burden is imposed on small entities as a result of the information collection. At the
same time, we provide assistance to sponsors of NDAs, BLAs, ANDAs, and authorized packers
and dispensers of human prescription drugs, including biological products through industry
guidance available at
https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm065016.ht
m and through the Center for Drug Evaluation and Research’s (CDER) Office of Small Business
and Industry Assistance.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory requirements
associated with the labeling of human prescription drugs, including biological products.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment in the
Federal Register of October 26, 2018, 2018 (83 FR 54110). We received one comment
suggesting that the use of “provider-neutral language” be incorporated into the Medication
Guide regulations. While we are appreciative of this comment, we decline to adopt the
suggestion at this time.
9. Explanation of Any Payment or Gift to Respondents
No remuneration is provided to respondents to the information collection.

2

10. Assurance of Confidentiality Provided to Respondents
We have reviewed this information collection to identify any potential risks to the privacy of
individuals whose information may be handled by or on behalf of FDA and to ensure appropriate
handling of information that may require privacy protection under the Privacy Act. In this case,
this information collection does not involve solicitation or collection of personally identifiable
information (PII) by or on behalf of FDA/CDER. Specifically, FDA/CDER does not intend to
collect personally identifiable information (PII) and will not maintain records subject to the
Privacy Act or otherwise operate a Privacy Act System of Records in relation to this specific
collection.
11. Justification for Sensitive Questions
This reporting burden does not involve any sensitive questions.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden for the information collection as follows:
Table 1.--Estimated Annual Reporting Burden
IC Activity;
21 CFR citation
Content and format of a
Medication Guide; § 208.20
Supplements/other changes to an
approved application;
§§ 314.70(b)(3)(ii) and 601.12(f)
Exemptions and deferrals;
§ 208.26(a)
TOTAL

No. of
Respondents
61

No. of
Responses per
Respondent
1

Total
Annual
Responses
61

Avg.
Burden per
Response
320

155

1

155

72

11,160

1

1

1

4

4

217

Total
Hours
19,520

30,684

Table 2.--Estimated Annual Third-Party Disclosure Burden
IC Activity;
21 CFR citation
Distribution: MGs to authorized
dispenser; § 208.24(c)
Distributing and Dispensing a
Medication Guide to Patient-§ 208.24(e)
TOTAL

No. of
Respondents
191

No. of
Disclosures
per
Respondent
9,000

88,736

5,705

Total
Annual
Disclosures
1,719,000
506,238,880
507,957,880

3

Avg.
Burden
per
Disclosure
1.25
0.05
(3 mins.)

Total
Hours
2,148,750
25,311,944
27,460,694

12b. Annualized Cost Burden Estimate
We estimate an average of 61 Medication Guides are submitted annually. Assuming each
Medication Guide requires 320 hours to prepare and submit to FDA, the industry cost, based on
and hourly rate of $75 per hour, is estimated at $1,464,000 (19,520 hours x $75/hr). We estimate
the cost of developing each Medication Guide to supplement existing applications would is
$6,100, and the cost for each generic drug Medication Guide is approximately $610.
FDA estimates that the sponsor of one of the new or supplementary applications will request an
exemption under § 208.26(a) from at least some of the Medication Guide format or content
requirements. FDA estimates that this will entail approximately 4 hours of work, or
approximately $300 (4 x $75/hr).
In addition, FDA estimates that 155 existing Medication Guides annually might require minor
change under § 314.70 (b)(3)(ii) or § 601.12 (f), necessitating 11,160 hours of full-time effort or
$837,000 (11,160 hours x $75/hr).
Under § 201.24(e), authorized dispensers are required to provide a Medication Guide directly to
the patient (or the patient’s agent) upon dispensing a product for which a Medication Guide is
required. This distribution of a Medication Guide to a patient is estimated to require 3 minutes of
a pharmacist’s time, $1,673,626,000 (25,311,944 hours x $66.12/hr) annually.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, or operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
Costs to the Federal government are absorbed through existing resource allocations covering the
review of NDAs, BLAs, and ANDAs.
15. Explanation for Program Changes or Adjustments
The information collection reflects an upward adjustment in the number of respondents, which
we attribute to an increase in submissions we have received over the past few years. We have
also corrected a calculation error in our annual third-party disclosure burden. These adjustments
result in an overall increase of 51 annual responses and 4,708 annual hours.

4

16. Plans for Tabulation and Publication and Project Time Schedule
FDA does not intend to publish tabulated results of the information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
The OMB expiration date will be displayed as required by 1320.8(b)(1).
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

5