0754 Supporting Statement A 2016 Extension

0754 Supporting Statement A 2016 Extension.pdf

GFI: Dear Health Care Provider Letters; Improving Communication of Important Safety Information

OMB: 0910-0754

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Guidance for Industry (GFI) and FDA Staff: Dear Health Care Provider Letters (DHCP);
Improving Communication of Important Safety Information
OMB Control No. 0910-0754

Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Under section 705 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 375(b)) (the FD&C
Act), the Secretary may cause dissemination of information regarding drugs in situations
involving, in the opinion of the Secretary, “imminent danger to health, or gross deception of the
consumer.” Food and Drug Administration (FDA) regulations at § 200.5 (21 CFR 200.5) outline
the general provisions for the “[m]ailing of important information about drugs,” but do not
provide instructions on the format and content of the actual letter. To assist manufacturers and
distributors in this regard, FDA has developed a guidance entitled, “GFI: Dear Health Care
Provider Letters: Improving Communication of Important Safety Information.” The guidance
provides recommendations on (1) when to issue a DHCP letter, (2) the types of information to
include in a DHCP letter, (3) how to organize that information so that it is communicated
effectively to health care providers, and (4) formatting techniques to make the information more
accessible. FDA is therefore requesting approval of the information collection provisions
associated with the guidance.
2. Purpose and Use of the Information Collection
The information collection provides a means for manufacturers, distributors, (individuals) and
the FDA (Federal Government) to communicate directly with health care providers responsible
for patient care about new or updated information regarding a human drug or biologic. A DHCP
letter is one of the mechanisms used to communicate important new information about a
marketed product that should be directed to all health care providers who are likely to prescribe,
dispense, or administer the drug, as well as others who need to know the disseminated
information. In most cases, the information relates to an important safety concern that could
affect prescribing decisions, patient counseling, or in some cases, contacting patients
immediately who may need to alter their behavior (e.g., switch medications or discontinue
Individual health care providers may use the information included in this information collection
to make decisions about what products to prescribe for their patients, and how to counsel patients
about their medications.

3. Use of Improved Information Technology and Burden Reduction
Although FDA regulations at § 200.5 focus on paper mailings of DHCP letters, the guidance
makes it clear that the recommendations apply to electronic communications as well (e.g.,
distribution by e-mail or made available on the Internet on company websites). FDA believes
that approximately 50% of manufacturers and distributers are currently using information
technology to distribute DHCP letters.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
While the information collection provisions apply to small and large businesses alike, FDA aids
small businesses in complying with its requirements through the agency’s Regional Small
Business Representatives and through the scientific and administrative staffs within the agency.
FDA has provided a Small Business Guide on the agency’s website at
6. Consequences of Collecting the Information Less Frequently
This information collection will occur strictly as it is needed based on how data evolve and
information emerges (e.g., important new safety information that concerns a significant health
hazard of a marketed product) since new or updated information about a drug product emerges
throughout a product’s life cycle. Collecting the information with any less frequency (e.g.,
annual or biennial updates, or every decade) would result in health care providers lacking timely
information crucial to patient care. Timeliness of drug safety information is fundamental for its
usefulness and anything less than as-needed frequency could be potentially catastrophic for
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
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in the
Federal Register of March 10, 2016 (81 FR 12734). No comments were received in response to
the notice.
9. Explanation of Any Payment or Gift to Respondents
No remuneration is provided for the information collection.


10. Assurance of Confidentiality Provided to Respondents
Confidential commercial information is protected from disclosure under the Freedom of
Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), by Section
301(j) of the FD&C Act, and by part 20 of the agency’s regulations (21 CFR part 20).
11. Justification for Sensitive Questions
The information collection contains no questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
Description of respondents: Respondents to the collection of information are manufacturers and
distributors of drug for which the issuance of a Dear Healthcare Provider Letter is required
under 21 CFR part 200.5.
12 a. Annualized Hour Burden Estimate
Based on a query of the FDA Document Archiving, Reporting, and Regulatory Tracking
System, FDA estimates that approximately 25 DHCP letters will be submitted annually from
approximately 18 application holders. FDA professionals familiar with DHCP letters and with
the recommendations in the guidance estimate that it should take an application holder
approximately 100 hours to prepare and send DHCP letters in accordance with the guidance.
FDA estimates the annual third-party disclosure burden as follows:
Table 1 – Estimated Annual Reporting/Third-Party Disclosure Burden1
21 CFR
§ 200.5

Mailing of Important
Information About Drugs

No. of

No. of





Burden per




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

12b. Annualized Cost Burden Estimate
FDA estimates an average manufacturer or distributor loaded wage rate of $110.13 per
hour for preparing and submitting the information collection described in this guidance.
Type of Respondent

Manufacturers and

Total Burden

Hourly Wage Rate




Total Respondent


Preparation of the DHCP letter requires clerical, medical, and legal input and review. Therefore,
in valuing the time cost, FDA uses the weighted average of Pharmaceutical and Medicine
Manufacturing (NAICS, Code 325400) industry-specific mean hourly wages for Office and
Administrative Support Occupations ($20.66), Life, Physical, and Social Science Occupations
($36.02), Legal Occupations ($74.13), and Management Occupations ($67.66). FDA assigns
these occupational categories weights of 10 percent, 30 percent, 30 percent, and 30 percent. The
resulting composite wage in 2015 is $55.41 (= [$20.66 per hour * 0.10] + [$36.02 per hour *
0.30] + [$74.13 per hour * 0.30] + [$67.66 per hour * 0.30]). FDA then doubles this amount to
$110.82 (= $55.41 per hour * 2) to account for benefits and any capital costs. (Source: U.S.
Bureau of Labor Statistics, “Occupational Employment Statistics: May 2015 National IndustrySpecific Occupational Employment and Wage Estimates NAICS 325400—Pharmaceutical and
Medicine Manufacturing,” available at http://www.bls.gov/oes/current/naics4_325400.htm,
March 30, 2016.)
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
14. Annualized Cost to the Federal Government
We estimate a total annual cost to the Federal government of $22,000 for the information
collection. Letters that concern a significant hazard to health or that change important drug
package labeling include FDA review to ensure they appropriately describe the safety concern,
labeling change(s), and/or correction of labeling/advertising necessary, and also to ensure the
letter is not false, misleading, or promotional, and finally to give other feedback to respondent
we feel necessary. The grade level of staff performing these tasks ranges from GS-13 to GS-15
and takes at most 16 hours (i.e., combined hours of all disciplines involved) to complete. We
receive approximately five to ten DHCP letters per year for an annual cost of $9,775. For letters
concerning a correction of prescription drug advertising or labeling this includes approximately
15 hours of drafting letters by GS-13 or GS-14 staff and 5 hours of review for an annual cost of
15. Explanation for Program Changes or Adjustments
The information collection shows a decrease. Because our records reflect there have been 7
fewer respondents to the collection, we have adjusted the corresponding number of annual
burden hours by 500 and responses by 5.
16. Plans for Tabulation and Publication and Project Time Schedule
The reporting requirements contained in this proposal will not be published, tabulated or


17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.


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