0393 Supporting Statement 2016 REV

Prescription Drug Product Labeling Medication Guide Requirements
OMB Control No. 0910-0393
SUPPORTING STATEMENT
Justification
1. Circumstances Making the Collection of Information Necessary
Food and Drug Administration (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. These
Medication Guides inform patients about the most important information they should know
about these products in order to use them safely and effectively. Included in the Medication
Guide (MG) is information such as the drug’s approved uses, contraindications, adverse drug
reactions, and cautions for specific populations, with a focus on why the particular product
requires a Medication Guide. The regulations are intended to improve the public health by
providing information necessary for patients to use certain medication safely and effectively.
While sponsors of New Drug Applications (NDAs), Biologics License Applications (BLAs), and
Abbreviated New Drug Applications (ANDAs) are subject to general labeling requirements
under regulations found in 21 CFR Parts 314 and 601, this information collection specifically
addresses patient labeling for human prescription drug products, including biological products,
as set forth under 21 CFR part 208.
21 CFR 208.20 explains the content and format of a Medication Guide that must be submitted
for FDA approval. Under regulations found at 21 CFR part 314.50 and 21 CFR 601.2, applicants
are required to provide this information to FDA as part of the subject application. Similarly,
when supplements or changes are necessary to current drug and biologics applications, under 21
CFR 314.70(b) (3) (ii) and 21 CFR 601.12(f), applicants are required to submit any changes to
the Medication Guide for FDA approval.
21 CFR 208.24(c) requires a distributor or packer that receives Medication Guides, or the means
to produce Medication Guides, to provide those Medication Guides to each authorized dispenser
to whom it ships a container of the drug product.
21 CFR 208.24(e) requires that each authorized dispenser of a prescription drug product for
which a Medication Guide is required, when dispensing the product to a patient or to a patient’s
agent, provide a Medication Guide directly to each patient unless exempt under 21 CFR 208.26.
21 CFR 208.26(a) allows applicants to submit requests for exemption or deferral from particular
Medication Guide content or format requirements.
FDA is therefore requesting OMB approval for the information collection associated with these
regulations.

2. Purpose and Use of the Information Collection
This information collection enables the agency to determine whether the labeling for certain
prescription drug products and biological products complies with 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 21 CFR part 208 may be submitted in electronic format provided that 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
to minimize burden on respondents. FDA provides resources to industry, including guidance,
regarding the submission of information in electronic format. These resources are available on
the agency’s website at http://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. While other information collection
requests cover specific labeling requirements (OMB Control Nos. 0910-0001, 0910-0338, and
0910-0572), this information collection specifically relates to the collection of information
associated with human prescription drugs, including biological products, subject to 21 CFR part
208.
5. Impact on Small Businesses or Other Small Entities
The information collection applies to all sponsors of NDAs, BLAs, ANDAs, and authorized
packers and dispensers of human prescription drugs, including biological products. FDA offers
assistance to small businesses through industry guidance available at
http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm065016.htm,
and through the Center for Drug Evaluation and Research’s (CDER) office of Small Business
and Industry Assistance (SBIA).
6. Consequences of Collecting the Information Less Frequently
Frequency of reporting is consistent with the statutory requirements associated with the labeling
of human prescription drugs, including biological products.
7. Special Circumstances Relating to the Guidelines in 5 CFR 1320.5
There are no special circumstances for this collection of information.

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8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice in the Federal Register of
May 29, 2015 (80 FR 30688). FDA received one comment in response to the notice requesting
clarification of FDA’s burden estimates for 21 CFR 208.24(c) (burden incurred by distributers of
Patient Medication Guides). The agency addressed the comment in its 30-day notice that
published on November 3, 2015 (80 FR 67762) attempting to provide such clarification, however
the agency will be particularly mindful of estimating burden for this disclosure burden as FDA
undertakes rulemaking to revise its patient medication information labeling regulations (0910AH33).
9. Explanation of Any Payment or Gift to Respondents
There is no payment to respondents
10. Assurance of Confidentiality Provided to Respondents
This reporting burden has no confidentiality implications.
11. Justification for Sensitive Questions
This reporting burden does not involve any sensitive question.
12. Estimates of Annualized Burden Hour and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden associated with the information as follows:
Table 1--Estimated Annual Reporting Burden
21 CFR Section;
Activity

208.20; MGs submitted
w/NDAs and BLAs
208.20; MGs submitted
as supplements or
updates
208.26(a); Exemptions
and deferrals
TOTAL
1

Total
Annual
Responses

Average Burden
per Response

57

No. of
Responses
per
Respondent
1

57

320

18,240

108

1

108

72

7,776

1

1

1

4

4

No. of
Respondents

Total
Hours

26,020

There are no capital costs or operating and maintenance costs associated with this collection of information. 

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Table 2—Estimated Annual Third-Party Disclosure Burden1
21 CFR Section

208.24(c); MG from
packer/distributor to
authorized dispenser
208.24(e); MG from
authorized dispenser to
patient
TOTAL
1

No. of
Respondents
191

No. of
Disclosures per
Respondent
9,000

Total
Annual
Disclosures
1,719,000

Avg.
Burden per
Disclosure
1.25

88,736

5,705

506,238,000

0.05
(3 mins.)

507,957,000

Total
Hours
2,148,750

25,311,900

27,460,650

There are no capital costs or operating and maintenance costs associated with this collection of information.

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
Compliance with requirements for Medication Guides is reviewed on a product-by-product basis
contemporaneously with the review of NDAs, BLAs, and ANDAs. We therefore estimate no
cost to the Federal government for this collection as expenditure for this review is calculated
under collections 0910-0001 (NDAs) and 0910-0338 (BLAs).
15. Explanation for Program Changes or Adjustments
FDA has adjusted its estimates associated with the collection as follows:
IC
1 – MGs submitted as part of NDAs and BLAs
2 – MGs submitted as updates
3 – Exemptions and deferrals
4 – MGs from packers/distributers to authorized dispensers
5 – MGs from authorized dispensers to patients
TOTAL

Responses
+32
+103
0
0
+211,238,000
211,238,135

Hours
+10,240
+7,416
0
0
+10,561,900
10,579,556

We note that the increase to IC 5 (Medication Guides from authorized dispensers to patients
under 21 CFR 204.24(e)) reflects adjustments over a six year period during which nearly 150
pharmaceuticals requiring the issuance of Patient Medication Guides have been included.
Additionally, we have revised the number of respondents to reflect information reported by the
National Association of Boards of Pharmacy (NABP) in a 2013 Survey of Pharmacy Law.
Although there are no estimates for the average number of medications distributed annually at a
single pharmacy, we can estimate the numbers associated with 208.24(e) based on a percentage
of products that have a medication guide. Of an estimated 3500 Reference Listed Drug (RLD)
products, 425, or 12.14%, have medication guides. Thus, multiplying the total number of
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prescriptions filled annually (4.17 billion) by the percentage of those with medication guides
(12.14 %) reflects 506,238,000 annual disclosures. Dividing the number of total annual
disclosures (506,238,000) by the number of pharmacies (88,736), shows 5,705 disclosures per
respondent. And finally, multiplying the total annual disclosures (506,238,000) by the average
burden per disclosure, reflects a total of 25,311,900 burden hours annually for this IC.
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
While there are no forms associated with this collection of information, the agency will display
OMB expiration as appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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